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Minutes for 253rd

Registration Board Meeting 1

Minutes for 253rd

Registration Board Meeting held on 05-06th

October, 2015.

Item No. Detail of Item Page No (s)

Item No.I Confirmation of minutes of 252nd

meeting Registration Board

04

Item No.II Cases referred by Pharmacy Services Division

04-13

Item No.III Cases referred by Pharmaceutical Evaluation & Registration Division

14-437

Item No.IV Additional Cases

438-514

Minutes for 253rd


Minutes for 253rd

Meeting Registration Board held on 05-06th

October, 2015.

253rd

meeting of Registration Board was held on 05-06th

October, 2015 in the Committee

Room, M/o National Health Regulation & Coordination. The meeting was chaired by Mr.

Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division. The

meeting started with recitation of the Holy Verses. The meeting was attended by the following:-

1. Prof. Dr.Rafi-uz-Zaman Saeed ul Haq

Dean Institute of Pharmacy, University of Lahore,

Islamabad.

Member

2. Lt General (R) Karamat Ahmed Karamat. Member

3. Brig (R). Dr. Muzammil Hasan Najmi,

Associate Dean, Basic Sciences Division,

Foundation Medical University, Rawalpindi

Member

4. Sheikh Sarfraz Ahmad

Deputy Draftsman, M/o Law and Justice

Member

5. Mr. A.Q.Javed Iqbal

Member

6. Dr.Muhammad Khalid Khan

Director Drugs Testing Laboratory

Government of Khyber Pakhtunkhwa, Peshawar

Member

7. Dr.Amanullah Khan


Government of Baluchistan, Quetta

Member

8. Mr.Jamil Anwar


Government of Punjab, Lahore

Member

9. Mr.Ghulam Mujtaba, Assistant Director

Representative of IPO

Member

10. Shaikh Ansar Ahmad

Director Biological Drugs, DRAP

Member

11. Dr.Noor Muhammad Shah

Director MD&MC, DRAP

Member

12. Zeeshan Nazeer Ch

Representative of QA&LT Division

Member

13. Dr. Obaidullah, Deputy Director General (Reg.I) Secretary/Member

Mr.Jamil Anwar and Mr.Ghulam Mujtaba attended the meeting on 06-10-2015.

Minutes for 253rd


Dr.Masud ur Rehman (DDG Biological), Dr.Tariq Siddique (DDG Regn-II), Zaheer ud

Din M Babar (DDC R.I / R IV), Muhammad Amin (DDC / Incharge, PEC), Zeeshan Nazeer

(DDC QA/ Chairman, QC), Adnan Faisal Saim (DDC QC), Babar Khan (ADC R.II / RIII),

Muneeb Ahmad Cheema (ADC PEC), Salateen Phillips (ADC PEC) and Rana Ahsan ul Haq

(ADC PEC) assisted relevant Directors and Secretary of the Board with agenda.

Shamim Ahmad, Shafiq Ahmad Abbasi, Nadeem Alamgeer and Abuzar Faizy attended

the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively.

Minutes for 253rd


Item No. I: Confirmation of minutes of 252nd

meeting Registration Board.

252nd

meeting of Registration Board was held on 07-08th

September, 2015. Draft minutes

were circulated to all members (who attended the meeting) through e-mail with the request to

forward their comments (if any) within 05 days. No comments have been received on draft

minutes.

Decision: Registration Board approved minutes of 251st Registration Board meeting.

Item No.II: Cases referred by Pharmacy Services Division.

Case No. 01. Tranexamic Acid for the treatment of gastrointestinal bleeding: an

International Randomised, double blind placebo controlled trial.

Haleema Shakur, Project Director, Trials Coordinating Centre, London School of

Hygiene and Tropical Medicine, Keppel Street, London, UK. Prof. Muttiullah Khan & Prof.

Rizwana Chaudhri of Holy Family Hospital, Said Pur Road, Rawalpindi have applied for

approval to conduct the subject trial in Pakistan at various sites. The short title of the trial is

“Haemorrhage Alleviation with Tranexamic Acid – Intestinal system (HALT- IT), trial.

This is a Phase III Clinical trial. List of sites alongwith names of Principal Investigators

has been provided by the Project Director. According to them the trial is an academic

collaboration of hospitals world wide and is being coordinated by the London School of Hygiene

and Tropical Medicine (LSHTM), University of London. As per documents submitted, the

salient features of the trial are as under:-

Aims:-

The HALT-IT trial will determine the effect of early administration of Tranexamic Acid

(TXA) on mortality, morbidity (re-bleeding, non fatal vascular events), blood transfusion,

surgical intervention and health status and patients with acute gastrointestinal bleeding.

Primary Outcome (Expected):-

The primary outcome is death in hospital within 28 days of randomisation (cause-specific

mortality will also be recorded).

Minutes for 253rd


Secondary Outcome (Expected):

a. Re-bleeding

b. Need for surgery or radiological intervention

c. Blood product transfusion

d. Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke,

myocardial infarction)

e. Other complication (significant cardiac event, sepsis, pneumonia, respiratory

failure, renal failure, liver failure seizures)

f. Patient‟s self care capacity using the Katz Index of Independence in Activities of

Daily Living

g. Days spent in intensive care unit or high dependency unit

Trial Design:

A pragmatic, randomised, double blind, placebo controlled trial among 8,000 patients

with significant gastrointestinal bleeding.

Diagnosis and Inclusion/Exclusion Criteria:

Adults with significant acute upper or lower gastrointestinal bleeding. The diagnosis of

significant bleeding is clinical but may include patients with hypotension, tachycardia, or those

likely to need transfusion, urgent endoscopy or surgery. The fundamental eligibility criterion is

the responsible clinician‟s uncertainty as to whether or not to use Tranexamic Acid in a

particular patient with GI bleeding. If the clinician believes there is a clear indication for, or clear

contraindication to, Tranexamic Acid use, the patient should not be randomised. There are no

pre-specified exclusion criteria.

Test Product, Reference Therapy, Dose and Mode of Administration:

A loading dose of Tranexamic acid (1 gram by intravenous injection) or placebo (sodium

chloride 0.9%) will be given as soon as possible after randomisation, followed by an intravenous

infusion of 3 grams of TXA or placebo (sodium chloride 0.9%) over hours.

Setting:

This trial is coordinated from the London School of Hygiene & Tropical Medicine

Clinical Trials Unit (University of London) and conducted in various hospitals worldwide.

Duration of Treatment and Participation:

Eligible patients should be randomised as soon as possible. The loading dose will be

given immediately after randomisation and the maintenance dose will be given immediately after

the loading dose, over 24 hours. Participation will end at discharge from randomizing hospital,

death or at 28 days post randomisation, whichever occurs first.

Minutes for 253rd


Criteria for Evaluation:

All patients randomly allocated to Tranexamic acid will be compared with those allocated

to placebo, irrespective of whether they received the allocated treatment or not („intention to treat

and analysis).

In the light of prevailing check list for clinical trial applications, the current status of

documents submitted by the applicant as pre-requisites is as follows:-

S. No. Document Remarks

1 Investigator Brochure (s) Yes

2 Final protocol Yes

3 Informed consent and participant

information sheet (Urdu to

English)

Yes

4 Fee No fee has been deposited. The fee for

clinical trial has not been defined under

“Schedule F”. However under the draft

Drugs (Bio-Study) Rules, 2011,

published under S.R.O. 61(1)/2011 dated

13-1-2011 following provision for

clinical trial fee has been given:-

a) Rupee Fifty thousand

(Rs.50000/=) for each principal

investigator in clinical trial.

b) Rupee Fifteen thousand

(Rs.15000/=) for clinical trial

site approval.

5 List of participating counties.

28 countries have been reported to

participate in the trial.

6 Phase of trial. Phase III

7 Quantity of drug / trial material

to be imported on Form 4 under

the Drugs (Import & Export)

Rules, 1976 and application for

import of trial material.

i) Injection Cyklokapron (Tranxamic

Acid), date of Mfg.11-2013

Mfd. By: Pfizer, Kent, UK.

Quantity:- 8000 x 500 mg ampoules,

contained within 1000 packs in a total

of 125 boxes.

ii) Sodium Chloride 0.9% Inj.

date of Mfg.30-07-2014

Mfd. By: South Devon Healthcare

NHS Foundation Trust.

Quantity:- 8000 x 500 mg ampoules,

contained within 1000 packs in a total

of 125 boxes.

iii) Sodium Chloride 0.9% Inj.

date of Mfg.29-06-2014

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Mfd. By: Baxter Healthcare, SA

Quantity:- 2000 x 100 ml bags

Each treatment pack also contains 2 x

sterile 10ml Syringes and 21 FG

needles.

Total amount of trial boxes applied

for import is 250 boxes of trial

treatment.

8 Independent Ethics Committee

(IEC)/Institutional Review

Board (IRB) approval of sites

with complete composition of

committee i.e. names and

designation of members.

Approvals of 05 sites by IRB/Research

Ethics Committee have been provided

with the documents where as request for

approval of 28 sites for conducting trials

has been made to DRAP. The applicants

have also not furnished approval letter

issued by National Bioethics Committee

(NBEC) of Pakistan.

9 CV‟s of the Investigators CVs of 08 PIs have been furnished

whereas the list indicates 30 PIs to

conduct the trial at various sites is given.

10 GMP certificate along with

COPP & free sale certificate of

the investigational product.

The GMP, COPP & Free Sale certificates

of the drug under investigation have not

been provided. The marketing

authorization of the placebo and COA of

the investigational drug have been

furnished only.

11 Pre-clinical/clinical safety

studies

Yes

12 Summary of Protocol Yes

13 Safety and progress report Yes

14 Adverse Event Reporting Form Yes

15 No of patients to be enrolled in

each centre.

8000 patients with diagnosed acute

gastrointestinal bleeding randomised will

be enrolled in participating hospital

selected worldwide. There is no limit to

the maximum number of patients to be

recruited at each site. It has been

estimated that minimum of 20 centres

will join the trial in Pakistan and that on

average 100 participants will be recruited

at each site

16 Name of monitors & clinical

research associate

30 Principle Investigator have been

mentioned to conduct the trial but

consent of only 8 is on record.

17 Evidence of registration in

country of origin.

Not provided, however it has been stated

that the drug is manufactured by Pfizer

Minutes for 253rd


Ltd under marketing authorization #

PL00032/0314 licensed by EMA. COA

of the drug has been provided. COPP is

required.

18 Evidence of registration in

Pakistan.

Not provided, however copy of National

Essential Drugs List of Pakistan has been

referred and as per section information

the drug is a registered in Pakistan under

the name Transamine.

19 Sample of label of the

investigational product / drug.

Yes

20 Duration of trial 04 years

Prima facie this is the case of grant of approval of clinical trial permission to be conducted as per

protocol submitted to the DRAP.

The Principal Investigator has been invited for short presentation regarding the subject title trial

before the Drug Registration Board on 06-10-2015 at 11;30 am.

The case is place before Registration Board for the following:-

i) Approval of the subject clinical trial namely Tranexamic Acid for the treatment of

gastrointestinal bleeding: an International Randomised, double blind placebo

controlled trial. The short title of the trial is “Haemorrhage Alleviation with Tranexamic

Acid – Intestinal system (HALT- IT), trial.

ii) Approval of the presently proposed clinical trial sites. (05 only whose IBR approval is

intact.

iii) Approval of proposed Principal Investigator for above 05 sites.

iv) Approval of fee .

v) Approval of Panel for post approval monitoring of trial sites from DRAP.

vi) Approval of proportionate trial material to be imported each time.

Decision: The case was considered by the Board in its 253rd

meeting held on 6-10-2015. In

the light of presentation made by the trial manager, discussion and

deliberations, the Board decided the matter as under:

i) The clinical trial namely Tranexamic Acid for the treatment of gastrointestinal

bleeding: an International Randomised, double blind placebo controlled trial was

approved in principle. The short title of the trial is “Haemorrhage Alleviation with

Tranexamic Acid – Intestinal system (HALT- IT), trial.

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ii) The Board approved five sites namely Allied Hospital, RMC Rawalpindi; Shifa

International Hospital, Ltd. Islamabad; Post graduate Medical Institute, Lady

Reading Hospital, Peshawar; DHQ Hospital, Khuzdar and DHQ Hospital,

Narowal, whose approvals from IBR are intact.

iii) Principal Investigators namely Dr. Matiullah Mutti, Holy Family Hospital,

Rawalpindi, Dr. Muhammad Umar, Rawalpindi Medical College, Rawalpindi, Dr.

Abdus Salam Khan, Shifa International Hospital, Islamabad, Dr. Aamir Ghafoor

Khan Lady Reading Hospital, Peshwar, Dr. Abdul Wahid DHQ Hospital

khuzdar, Dr. Sajjad, DHQ Hospital, Narowal, whose consents/CVs are intact,

were also approved.

iv) The fee for Clinical trial as proposed in the Bio Study Rules, 2011 was

recommended by the Board for inclusion in Schedule F of the Drugs (Lic, Reg &

Adv) Rules, 1976.

v) Regarding the panel for post approval monitoring of the trial sites, it was decided

that the member of the Registration Board from the concerned Province will head

the panel and the other members from the regional DRAP office or DRAP

Islamabad will associate for such inspection.

vi) Permission for import of proportionate trial material and other regulatory

deficient documents will be considered as per Drugs (Import and Export) Rules,

1976 by competent authority.

Case No. 02 The Efficacy of Varenicline in Achieving Abstinence Among Hookah

Smokers-a Two Arm, Double Blind, Placebo Controlled Study-Funded By

Pfizer (Hookah Trial).

Dr. Raana Zahid, Principal Investigator has sent details of proposed clinical trial of a

chemical “Varenicline” for looking at the efficacy of “Varenicline” in achieving abstinence

among Hookah Smokers-a Two Arm, Double Blind, Placebo Controlled Study-Funded by Pfizer

(Hookah Trial). It has been stated that “The Initiative‟ Pakistan” is a private, non-government

trust organization based at Islamabad, established recently by a group of public health

professionals who are working closely with the University of Leeds and University of York on

tobacco related quantitative and qualitative related research projects. The Pakistan team is

basically an extension of the University of York, UK. Dr. Raana has further informed that the

University of York has successfully implemented and published policy research and Randomized

Controlled Trials.

2. As per documents submitted, the salient features of the trial are as under:-

Minutes for 253rd


Background:

Hookah smoking has increased among youth across the globe including the US, and it

continues as a common and traditional form of smoking tobacco in Pakistan. A range of

behavioral and pharmacological therapies is available to support people in quitting cigarette

smoking; however, little evidence exists on the efficacy of these therapies in achieving

abstinence among hookah smokers.

Research objective:

To assess the efficacy of Varenicline when added to behavioral support for smoking

cessation, by measuring biochemical validated continuous abstinence in hookah smokers.

Design:

A two-arm, double blind, randomised, placebo-controlled, stated to be Phase III trial.

Setting:

At three district hospitals in Punjab, Pakistan (Sargodha, Khushab and Mandi Bahudding)

Participants:

Adults, using hookah (with or without concomitant cigarette, bidi, or other tobacco

smoking) on a daily basis for at least six-months and are willing to quit smoking, will be eligible.

individually randomise 510 participants to one of the two arms of the trial.

Interventions:

Arm 1: Varenicline + Behavioural Support

Arm 2: Placebo + Behavioural support

Measurements:

As per Russell‟s Standard, primary outcome will be continuous abstinence for at least six

months which is bio-chemically verified by a carbon monoxide level of 10 ppm at 5, 12 and 25

weeks post randomisation. Secondary outcomes will include bio-chemically verified point

abstinence at 5, 12 and 25 weeks and any lapses and relapses between the different assessment

points. Tertiary outcomes will include assessment of withdrawal symptom using Mood and

Physical Symptoms Scale (MPSS), smoking dependency using Lebanon Water pipe Dependency

Scale (LWDS-11), and monitoring adverse outcomes.

In the light of prevailing check list for clinical trial applications, the current status of

documents submitted by the applicant as pre-requisites is as follows:-

S. No. Document Remarks

1 Investigator Brochure (s) Yes

2 Final protocol Yes

3 Informed consent and participant

information sheet (Urdu to English)

Yes

Minutes for 253rd


4 Fee The fee for clinical trial has not been

defined under “Schedule F”. However

under the draft Drugs (Bio-Study) Rules,

2011, published under S.R.O. 61(1)/2011

dated 13-1-2011 following provision for

clinical trial fee has been given:-

a) Rupee Fifty thousand (Rs.50000/=) for

each principal investigator in clinical

trial.

b) Rupee Fifteen thousand (Rs.15000/=)

for clinical trial site approval.

The applicant has deposited Rs.5000/=

fee for clinical trial.

5 List of participating counties.

The trial is being conducted in Pakistan

only.

6 Phase of trial. Phase III

7 Quantity of drug / trial material to be

imported on Form 4 under the Drugs

(Import & Export) Rules, 1976 and

application for import of trial material.

i) Varenicline tartrate 0.5mg Tablets.

Quantity:- 2805 tablet units (255

packages having 11 tablets per

package.)

ii) Placebo 0.5mg Tablets.



package.)

iii) Varenicline Tartrate 1mg Tablets.



package.)

iv) Placebo 1mg Tablets.



package.)

8 Independent Ethics Committee

(IEC)/Institutional Review Board (IRB)

approval of sites with complete

composition of committee i.e. names and

designation of members.

Approvals from Independent Ethics

Committee (IEC) / Institutional Review

Board (IRB) of proposed 03 sites have not

been provided with the documents.

However, the applicant has furnished

approval letter issued by National

Bioethics Committee (NBEC) of Pakistan.

9 CV‟s of the Investigators CVs of Chief Investigator, PI and trial

Manager in Pakistan have been furnished.

However the names of research/study

associates/PIs to be involved in trials at

the three proposed sites have not been

provided.

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10 GMP certificate along with COPP & free

sale certificate of the investigational

product.

The GMP, COPP & Free Sale certificates

of the drug under investigation have not

been provided. However it has been stated

that Pfizer USA has been requested to

provide necessary documents and they are

processing our request.

11 Pre-clinical/clinical safety studies Yes

12 Summary of Protocol Yes

13 Safety and progress report Yes

14 Adverse Event Reporting Form Yes

15 No of patients to be enrolled in each

centre.

510 Participants will be enrolled in three

centres of study located at Sargodha,

Khushab and Mandi Bahauddin.

16 Name of monitors & clinical research

associate

The names of research/study

associates/PIs to be involved in trials at

the three proposed sites have not been

disclosed/ provided.

17 Evidence of registration in country of

origin.

Not provided, however it has been stated

that Pfizer USA has been requested to

provide necessary documents and they are

processing their request.

18 Evidence of registration in Pakistan.

Not provided, however as per section

information the drug is registered in

Pakistan.

19 Sample of label of the investigational

product / drug.

Not provided, it has been stated that the

sample of the label will be furnished as

soon as it is ready to be shipped to

Pakistan after receiving the NOC from

DRAP.

20 Duration of trial 02 years

The matter has been referred to the following two experts; however, the opinion of both

of the experts is still awaited:-

i) Dr. Huma Qureshi, Executive Director, PMRC.

ii) Brig. (R)/Dr. Muzammil H. Najmi, Member Registration Board.

Prima facie this is the case of grant of approval of clinical trial permission to be

conducted as per protocol submitted to the DRAP.

The Principal Investigator / Trial Manager has been invited for short presentation

regarding the subject titled trial before the Drug Registration Board 06-10-2015 at 12:30 pm.

The case is placed before the Registration Board for the following:-

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i) Approval of the subject clinical trial namely The Efficacy of Varenicline in

Achieving Abstinence among Hookah Smokers-a Two Arm, Double

Blind, Placebo Controlled Study-Funded By Pfizer (Hookah Trial).

ii) Approval of the presently proposed clinical trial sites subject to provision of

approvals from the IRBs.

iii) Approval of Principal Investigator for each site subject to provision of their CVs and

consent to conduct the trial.

iv) Approval of fee as mentioned above in para 3 (4).

v) Approval of Panel for post approval monitoring of trial sites from DRAP.

vi) Approval of proportionate trial material to be imported each time.

Decision: - The case was considered by the Board in its 253rd

meeting held on 6-10-2015. In the

light of presentation made by the trial manager, discussion and deliberations, the

Board decided the matter as under:

i) The clinical trial namely The Efficacy of Varenicline in Achieving Abstinence

among Hookah Smokers-a Two Arm, Double Blind, Placebo Controlled

Study-Funded By Pfizer (Hookah Trial) was approved by the Board.

ii) The Board approved three proposed sites namely DHQ Hospital, Sargodha,

DHQ Hospital, Mandi Bhauddin and DHQ Hospital, Khushab subject to

provision of approvals from the IRBs. It was also advised to have laison with

teaching Hospital for better conduction/monitoring of the trial/study.

iii) Principal Investigators namely Dr. Raana whose CV is intact was also

approved. Approval of Principal Investigators for the proposed three sites

subject to provision of their CVs and consent to conduct the trial was also

approved.

iv) The fee for Clinical trial as proposed in the Bio Study Rules, 2011 was

recommended by the Board for inclusion in Schedule F of the Drugs (Lic, Reg

& Adv) Rules, 1976.

v) Regarding the panel for post approval monitoring of the trial sites, it was

decided that the member of the Registration Board from the concerned

Province will head the panel and the other members from the regional DRAP

office or DRAP Islamabad will associate for such inspection.

vi) Permission for import of proportionate trial material and other regulatory

deficient documents will be considered as per Drugs (Import and Export)

Rules, 1976 by competent authority.

Minutes for 253rd


Item No.III: Cases referred by Pharmaceutical Evaluation & Registration Division.

A. Registration of Drugs.

Case No.01: Grant of registration of drugs deferred for stability data.

Registration Board in various meetings deferred registration applications of new molecules / formulations for submission of laboratory scale

scientifically rational stability data. Later on Registration Board in its 251st meeting held on 12-13

th August 2015 framed guidelines for submission of

stability data which were communicated to all applicants. The decision of Board is as follows.

“Registration Board deferred the case and advised applicants to provide scientifically rational lab scale data as per requirements decided in the

meeting. However, for the applicants who were previously advised for provision of stability data may provide stability data for testing frequency of at least

0, 3 and 6 months in addition to other requirements approved by Registration Board in instant meeting”.

Stability Study Data Sheet

1.0 Product details:

Product name /Generic

name/Dosage form ABCD 100mg tablets Batch No.

Description of pack

(container closure system)

e.g: 300mg uncoated 10mm off white round tablet

blistered in 250mn PVC, 25mm aluminum foil in a 10x 1

printed unit carton, 100 u/c further packed in a master

shipper.

Batch Size.

Parameters and tests mentioned As per Product Specifications Mfg. Date

Recommended storage

conditions

Short term conditions (Accelerated) 40+ 2C, 75

+5RH

Long term conditions (Real time) 30+ 2C, 65 +5

RH

Exp Date

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Date of initiation &

implementation (API) lot no.

Stability No.

Approval by:

QC Manager:---------------------

QA Manager:---------------------

Production Manager:----------

R&D Manager:-------------------

Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 16 20 24 26

Date of Testing

Mode of testing(F = full, P = Partial testing) F P F P F F F F F F F F

Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

conditions

(Accelerated)

40oC + 2

oC & 75%RH

+ 5% RH

40oC + 2

oC & 75%RH

+ 5% RH

40oC + 2

oC & 75%RH

+ 5% RH

40oC + 2

oC & 75%RH

+ 5% RH

Sample taken for physical tests =

Sample taken for Chemical tests =

Sample taken for Microbiological tests =

Extra samples (if needed) =

Total Sample size (approx) =

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40oC + 2

oC & 75%RH

+ 5% RH

Analyst signature (after completion of every time line)

Conclusion by QA (after completion of the study):


Date of Testing

Mode of testing(F = full, P = Partial testing) F P F P F F F F F F F F

Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

conditions

(Real Time)

30 C + 2oC,

65% +5% RH

30 C + 2oC,

65% +5% RH

30 C+ 2oC,

65% +5% RH

30 C + 2oC,

65 %+5% RH

30 C+ 2oC,

65% +5% RH

Minutes for 253rd




Documents / Data to be provided by the applicants

Certificate of Analysis of API.

Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of

country of origin.

Manufacturer will follow Drug Specification Rules, 1986.

Protocols followed for conduction of stability study and details of tests.

Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc.

Documents confirming import of API etc.

All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.

Shelf life of two years shall be granted based upon the results 06 month accelerated and real time stability study data.

Commitment to continue real time stability study till assigned shelf life of the product.

Furthermore all applicants have also been called for presentation of their data before the Registration Board. The applicants who have submitted the

stability data has been tabulated below for consideration of Registration Board please.

a. Sofosbuvir 400mg Tablet.

All the applications for registration of Sofosbuvir 400mg Tablet were initially discussed in the 244th

meeting of Registration board

held on 22-23rd

July 2014 wherein the Board decided that in addition to individual dossier deficiencies, every manufacturer will provide

additional data as decided by Registration Board in 240th

meeting for new drug molecule. Later on, Registration Board in its 251st meeting

held on 12-13th

August 2015 framed guidelines for submission of stability data which were communicated to all applicants, who had applied

for registration of the aforesaid drug.

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Registration Board provided an opputunity to all the applicants to present stability data before the Board. 28 applicants provided the

stability data and presented their cases whereas 35 applicants did not provide the same.

Following firms have not submitted stability data but their representatives attended the meeting.

S.No Name Designation & Organization

1. Shaigan Pharmaceuticals (Pvt) Ltd Ghulam Muhammad, (GM, R&D)

2. OBS Pharma, Karachi Mohammad Amjad, Director Industrial Operatoion

3. Rasco Pharma, Lahore Hussnain Raza, Plant manager

4. Dyson Research Lab, Lahore Muhammad Rafique, Quality Control Manager

5. Cirin Pharmaceutical, Hattar Sohail Qaiyum, Quality Control Manager

6. Valor Pharma, Islamabad Asif Iqbal, Quality Control Manager

7. Helix Pharma, Karachi Dr. Obaid Siddiqui, GM Quality Operation

8. Friends Pharma, Lahore Shahid Nadeem, Quality Control Manager

9. Novamed Pharma, Lahore M. Jehangir, Quality Control Manager

10. Saiben Pharma, Muhammad Rafiq, Production Manager

11. Neutro Pharma, Lahore Shahid Niazi, Quality Assurance Manager

12. English Phamaceutical, Lahore Muhammad Nadeem Shahid, Director Operation

13. Schazoo Pharmaceuticals, Lahore Asad Farooq, R&D Manager

14. Rotex Pharma, Islamabad Malik Ikram Shaukat, Quality Control Manager

15. Akson Pharma, Muhammad Azeen, Quality Control Manager

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16. Safron Pharma, Faisalabad Hafiz Muhammad Ibrahim, Quality Control Manager

17. Martin Dow, Karachi Dr. Shafiq ur Rehman,Head of Quality

18. Wilshire Laboratories, Lahore Farhan Qureshi, Quality Assurance Manager

After listening to above representatives, Registration Board advised manufacturers to sumit stability data and other documents as per

requirements decided in 251st meeting of Registration Board. Some manufacturers informed that their cases for permission by DRAP

regarding import of raw materials for the conduction of stability testing are pending. Registration Board deliberated that Quality Assurance

Division has already been advised in 245th

meeting of the Board held on 29-30th

September, 2014 to dispose off cases of raw material import

for conduction of stability studies and product development on priority basis. However keeping in view manufacturer‟s submission, Quality

Assurance Division was again re-iteriated to process such cases on priority without further delay.

Mr. A.Q. Javed Iqbal, Member Registration Board opined that level field should have been provided to all the players and decisions

should be transparent and across the board. He observed that some manufacturers have also been advised to provide clinical trial data.

Registration Board was apprised that in 244th

meeting all applicants were advised to provide following data inaddition to individual dossier

deficiencies:

a. Prescribing information (PI), Patient Information Leaflet (PIL) and Summary of product characteristics (SmPC) as per Approved by

Drug regulatory agencies or authorities of country of origin or FDA, EMA, TGA, Health Canada and MHLW (Japan)

b. Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.

c. Clinical Data / Clinical trials

d. Clinical justification

e. International availability specially in FDA, EMA, Health Canada, TGA & MHLW (Japan) of same generic, dosage form & strength

etc.

Minutes for 253rd


Registration Board discussed reference sent by PPMA stating that Registration Board should not grant registrations to Sofosbuvir

400mg Tablets from India as local pharmaceutical manufacturers can manufacture it. A delegation of PPMA led by its Chairman (Mr. Hamid

Raza) also shared same plea before Registration Board. The Board deliberated the request in detail and also discussed that parameters for

grant of registration are safety, efficacy and quality. Registration Board discussed PPMA‟s letter and members were of the view that Import

Policy Order 2012-2015, Ministry of Commerce doesn‟t restrict import of Sofosbuvir 400 mg tablets from India. However, keeping in view

presentation made by PPMA, the Board decided to get opinion of Ministry of Commerce regarding importability of Sofosbuvir 400 mg

tablets from India for updated status as mentioned in PPMA‟s letter.

Registration Board discussed that stability data submitted by the manufacturers will be discussed on case to case basis in presence of

firm‟s representatives. The Board discussed that cases will be evaluated in the light of decision of 251st Registration Board meeting for

requirement of documents and data. Moreover, data should include required pharmacopeial test as applicable to specific dosage form.

Manufacturers who complied aforementioned provisions will be granted registration. Registration Board decided that in order to further

ensure quality of the product and being first generic of new molecule, manufacturer will inform concerned Federal Inspector of Drugs for

taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs

Laboratory, Karachi before sale of finished product.

Thereafter, Board discussed individual applications of new molecules for which stability data was provided and following decisions

were taken:

Minutes for 253rd


1. SAMI PHARMA, KARACHI

Drug SOFVIR tablets (Sofosbuvir) 400 mg

Source M/s Lauras Labs India

Storage Condition Real Time: 30 C and 75% RH

Accelerated: 40 C and 75% RH

Time Period Real Time: 6 months

Accelerated: 6 months

Frequency 0, 1,2, 3,5, 6 months

Batch Size Batch 1: 300 tab

Batch 2: 410 tab

Batch 3: 410 tab

No. of Batches 03

Sample Size 25 tablets

Meeting Deferred in 244th

and 251st meeting of

Registration Board for stability as per

WHO/ICH guidelines

Batch 1 Accelerated

Parameters Appearance

Disintegration

Time

(in minutes)

Average

weight

(g /tab.)

Dissolutio

n

(%)

Assay

(%)

Specification

White to off white

oval shape tablets,

plain on both sides

Within 30

minutes

1.1742 to

1.2978 NLT 80

NLT 90

and NMT

110

Initial result

White oval shape

tablets, plain on both

sides

6‟:10‟‟ 1.239 100.77 105.91

Minutes for 253rd


After 1

months // 6‟:24‟‟ 1.2341 100.29 104.68

After 3

months // 6:59‟‟ 1.2344 99.23 103.19

After 5

months // 7‟:16‟‟ 1.2347 98.09 102.14

After 6

months // 7‟:25” 1.2355 97.56 100.87

Real Time


Disintegration

Time

(in minutes)

Average weight

(g /tab.) Dissolution

(%)

Assay

(%)

Specification

White to off white

oval shape tablets,

plain on both sides

Within 30

minutes

1.1742 to

1.2978 NLT 80

NLT 90

and NMT

110

Initial result

White oval shape


sides

6‟:10‟‟ 1.239 100.77 105.91

After 3

months // 6‟:19‟‟ 1.240 100.15 104.90

After 5

months // 6:35‟‟ 1.2342 99.65 103.55

After 6

months // 6:49‟‟ 1.2350 98.19 102.12

Minutes for 253rd


Batch 2

Accelerated

Parameters Appearance Disintegration Time

(in minutes)

Average

weight

(g /tab.)

Dissolution

(%)

Assay

(%)

Specification

White to off white

oval shape tablets,

plain on both sides

Within 30

minutes

1.1742 to

1.2978 NLT 80

NLT 90 and

NMT 110

Initial result

White oval shape


sides

6‟:12‟‟ 1.2237 100.60 104.60

After 1

months // 6‟:45‟‟ 1.2239 100.30 103.59

After 3

months // 7‟:08‟‟ 1.2341 99.34 102.97

After 5

months // 8‟:03‟‟ 1.2343 98.92 101.36

After 6

months // 8‟:23‟‟ 1.2353 95.44 100.32

Real Time


Disintegration

Time

(in minutes)

Average

weight

(g /tab.)

Dissolution

(%)

Assay

(%)

Specification

White to off white

oval shape tablets,

plain on both sides

Within 30

minutes

1.1742 to

1.2978 NLT 80

NLT 90

and NMT

110

Initial result White oval shape

tablets, plain on both 6‟:12‟‟ 1.2237 100.60 104.60

Minutes for 253rd


sides

After 3

months // 6‟:25‟‟ 1.2239 100.22 103.79

After 5

months // 6‟:49‟‟ 1.2300 99.75 102.99

After 6

months // 6‟:55‟‟ 1.2309 97.43 102.08

Batch 3 Accelerated


Disintegration

Time

(in minutes)

Average

weight

(g /tab.)

Dissolution

(%)

Assay

(%)

Specification

White to off white oval

shape tablets, plain on both

sides

Within 30

minutes

1.1742 to

1.2978 NLT 80

NLT 90 and

NMT 110

Initial result White oval shape tablets,

plain on both sides 6‟:14‟‟ 1.2382 101.26 105.84

After 1 months // 6‟:25‟‟ 1.2385 100.68 104.40

After 3 months // 6‟:44‟‟ 1.2389 99.18 103.48

After 5 months // 7‟:14‟‟ 1.2391 97.96 102.11

After 6 months // 7‟:34‟‟ 1.2399 95.57 101.84

Real Time


Disintegration

Time

(in minutes)

Average

weight

(g /tab.)

Dissolution

(%)

Assay

(%)

Specification

White to off white oval

shape tablets, plain on both

sides

Within 30 minutes 1.1742 to

1.2978 NLT 80

NLT 90

and NMT

110

Minutes for 253rd


Initial result White oval shape tablets,

plain on both sides 6‟:14‟‟ 1.2382 101.26 105.84

After 3 months // 6‟:20‟‟ 1.2386 100.70 104.75

After 5 months // 6‟:34‟‟ 1.2386 100.18 103.50

After 6 months // 6‟:45‟‟ 1.2390 97.47 101.75

Documents / Data provided by the applicants (M/s Sami, Karachi)

Sr. No. Documents to be provided Status

1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or GMP certificate of API

manufacturer issued by regulatory authority of country of origin.

Yes (Photocopy

provided)

3. Protocols followed for conduction of stability study and details of tests. Yes

4. Data of 03 batches will be supported by attested respective documents like

chromatograms, laboratory reports, data sheets etc.

Yes

5. Documents confirming import of API etc. Yes (By courier)

6. All provided documents will be attested (name, sign and stamp) for ensuring

authenticity of data / documents.

Yes

7. Commitment to continue real time stability study till assigned shelf life of the product. No

Decision: Mr.Shamim Akhter, Director Quality Operations presented the data. Registration Board observed that the stability data

provided by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted

approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of

Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from

Central Drugs Laboratory, Karachi before sale of finished product.

Minutes for 253rd


2. M/s Genix Pharma, Karachi

Drug Sofo tablets (Sofosbuvir) 400 mg

Source Zhejiang Jiangbei, Pharmaceutical Co. Ltd China

Storage Condition Accelerated: 40 C and 75% RH

Real Time: 30°C ± 2°C/65% ± 5% RH)

Time Period 6 months

Frequency 0, 1, 3, 6 months

Batch Size Batch 1 and 2: 225 tabs/ batch

Batch 3: 4985 tabs

No. of Batches 03

Sample Size 20 tablets per test

Meeting Deferred in 244th and 251

st meeting of Registration Board

Batch 1 Accelerated Stability Study (40°C ± 2°C, 75% ± 5% RH)

Product: SOFO 400mg tablet Mfg. Date: 09-2014 Date of Commencement: 12-09-2014

Product Code: NA Exp. Date: 09-2016 Date of Completion: 12-03-2015

Batch No.: TR001 Shelf Life: 2 Years Pack Size: 14‟s

Packaging: HDPE Bottle with Cap, pilfer-proof Specifications No/Version: GENIXQC-SOP-SF-140/00

Reason For Stability: Trial batch for registration purpose and shelf life.

Parameters Assay Dissolution Impurities Disintegration

Time

(minute)

Physical Observation

Specifications Label Claim

400mg/tablet

NLT 80% Unspecified NMT

0.5%

NMT 30

minutes

Oblong yellow biconvex

coated tablets engraved

Minutes for 253rd


Limits

(90%-110%)

Total NMT 1.0% “Genix” on one side plain

on other side.

Intervals

Initial Results 99.19% 99.1% ND 2.39 mins Complies

3rd

month 99.44% 95.5%

Unspecified Impurity

0.034%

Total Impurities

0.034%

2.39 mins Complies

6th month 99.21% 93.9%


0.182%

Total Impurities

0.182%

2.41 mins Complies

Real Time Stability Study (30°C ± 2°C/65% ± 5% RH)




Packaging: HDPE Bottle with Cap, pilfer-proof Specifications No/Version: GENIXQC-SOP-

SF-140/00



Time (minutes)



400mg/tablet


0.5%

NMT 30

minutes



Minutes for 253rd


Limits

(90%-110%)

Total NMT 1.0% “Genix” on one side plain

on other side.

Intervals


3rd

month 99.06% 96.6% ND 2.27 mins Complies

6th month 99.0% 94.0%


0.186%

Total Impurities

0.186%

2.19 mins

Complies

Batch 2 Accelerated Stability Study (40°C ± 2°C, 75% ± 5% RH)




Packaging: HDPE Bottle with

Cap, pilfer-proof Specifications No/Version: GENIXQC-SOP-SF-

140/00



time



400mg/tablet

Limits

(90%-110%)


0.5%

Total NMT 1.0%

NMT 30

minutes



“Genix” on one side plain on

other side.

Minutes for 253rd


Intervals↓


3rd

month 100.68% 96.7%


0.039%

Total Impurities

0.077%

2.14 mins Complies

6th month 99.0% 94.2%


0.179%

Total Impurities

0.179%

2.10 mins Complies






SF-140/00



time



400mg/tablet

Limits


0.5%

Total NMT 1.0%

NMT 30

minutes



“Genix” on one side

Minutes for 253rd


(90%-110%) plain on other side.

Intervals↓


3rd

month 100.24% 96.5%


0.003%

Total Impurities

0.003%

2.40 mins Complies

6th month 99.70% 92.3%


0.181%

Total Impurities

0.181%

2.31 mins

Complies

Batch 3 Accelerated Stability Study (40°C ± 2°C/75% ± 5% RH)

Product: SOFOS 400mg tablet Mfg. Date: 02-2015 Date of Commencement: 02-2015

Product Code: NA Exp. Date: 02-2017 Date of Completion: 08-2015

Batch No.: G094 Shelf Life: 2 Years Pack Size: 7‟s

Packaging: HDPE Bottle Specifications No/Version: GENIXQC-SOP-SF-140/00

Batch Size: 4985

Reason For Stability: New products for shelf life estimation.


time



400mg/tablet

Limits

(90%-110%)

NLT 80% Unspecified NMT 0.5%

Total 1.0%

NMT 30

minutes



“Genix” on one side plain

on other side.

Intervals↓

Initial Results 98.09% 95.26 % ND 4.12 minutes Complies

Minutes for 253rd


1st month 100.87% 97.09% ND 2.54 minutes Complies

2nd

month 100.55% 96.55% ND 3.12 minutes Complies

3rd


4th


5th


6th


Reference Record STR-001/022

Signature





SF-140/00



Time (minutes)



400mg/tablet

Limits

(90%-110%)


0.5%

Total NMT 1.0%

NMT 30

minutes



“Genix” on one side plain

on other side.

Intervals


Minutes for 253rd


3rd

month 99.06% 96.6% ND 2.27 mins Complies

6th month 99.0% 94.0%


0.186%

Total Impurities

0.186%

2.19 mins

Complies


Product: SOFOS 400mg tablet Mfg. Date: 02-2015 Date of Commencement: 02-2015

Product Code: NA Exp. Date: 02-2017 Date of Completion: 02-2017

Batch No.: G094 Shelf Life: 2 Years Pack Size: 7‟s

Packaging: HDPE Bottle Specifications No/Version: GENIXQC-SOP-SF-140/00

Batch Size: 4985

Reason For Stability: New products for shelf life estimation.


Time



400mg/tablet

Limits

(90%-110%)

NLT 80% Unspecified NMT 0.5%

Total 1.0%

NMT 30

minutes

Oblong yellow biconvex coated

tablets engraved “Genix” on

one side plain on other side.

Intervals↓

Initial Results 98.09% 95.26 % ND 4.12 minutes Complies

3rd


6th


Minutes for 253rd


Reference Record STR-001/04,20 STR-001/04 STR-001/04,20 STR-001/04,20 STR-001/04,20

Signature

Documents / Data provided by the applicant (M/s Genix Pharma, Karachi)


1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or GMP

certificate of API manufacturer issued by regulatory authority of country of

origin.

Yes

(Copy of GMP certificate

provided)




Yes (Attested photocopies

provided)

5. Documents confirming import of API etc. Yes (ADC cleared)



Yes

7. Commitment to continue real time stability study till assigned shelf life of the

product.

Yes

Decision: Mr. Masood-ur-Rehman, Manager Quality Control presented the data. Registration Board observed that the stability data





Minutes for 253rd


3. M/s Crystolite Pharma, Islamabad

Drug Hepvir tablets (Sofosbuvir) 400 mg

Source M/s Qingdao Fraken, China





Frequency 0, 1,2, 3,6 months


Batch 2: 400 tab

Batch 3: 400 tab

No. of Batches 03


Meeting Deferred in 251st meeting of Registration Board for stability

(AT ACCELERATED CONDITIONS)

Hepvir(Sofosbuvir) 400mg Tablet Batch No.TCP-001 Batch Size 400 Tablets

S.NO TEST SPECIFICATIONS

O Month

02-02-2015

01

Month

02-03-2015

02

Month

02-04-2015

03

Month

04-05-2015

06 Month

04-08-2015

Month

Manufacturing Date 02-2015 Expiry Date 02-2017

Date Of Manufacture 02/02/2015 Sample Size 20 Tablets

Minutes for 253rd


1 Physical Appearance

White, oblongfilm coated tablet with

Crystolite` on one side & plain on

other side.

Complies Complies complies complies complies

2 Identification Sofosbuvir must be positive +ve +ve +ve +ve +ve

3 Disintegration Time NMT 30 minutes 6.15 minutes 6.09 Minutes 6.45minutes 5.55 minutes 6.14 minutes

Average weight of the

tablet 700mg±5.0% 766 769 762 761 769

4 Dissolution NLT 85% in 20 minutes 94.5% 93.8% 95.2% 93.4% 92.5%

4 Assay 90 % to 110 % 100.14 % 99.96% 98.82 % 99.78% 100.63 %

PRODUCT STABILITY TESTING REPORT CONDUCTED AT 40°C ± 2, RH 75 % ± 5


Hepvir(Sofosbuvir) 400mg Tablet Batch No.TCP-002 Batch Size 400 Tablets

S.NO TEST SPECIFICATIONS O Month

03-03-2015

01

Month

03-04-

2015

02

Month

05-05-

2015

03

Month

03-06-2015

06 Month

03-09-2015

Month


Date Of Manufacture 03/03/2015 Sample Size 20 Tablets

Minutes for 253rd




Crystolite` on one side & Bisected

on other side.

Complies Complies complies complies Complies


3 Disintegration Time NMT 30 minutes 6.23

minutes

6.

45Minutes 6.0minutes 5.55minutes 5.35 minutes


tablet 700mg±5.0% 766 762 765 768 762


4 Assay 90 % to 110 % 98.75 % 99.52% 99.43 % 99.82% 99.95%



Hepvir(Sofosbuvir) 400mg Tablet Batch No.TCP-003 Batch Size Tablets 400


O Month

10-03-2015

01

Month

10-04-2015

02

Month

11-05-

03

Month

10-06-2015

06 Month

10-09-2015

Month


Date Of Manufacture 10-03-2015 Sample Size 20 Tablets

Minutes for 253rd


2015




on other side.

Complies Complies Complies complies complies


3 Disintegration Time NMT 30 minutes 6.10 minutes 6. Minutes 5.55

minutes 6.22 minutes 5.59 minutes


tablet 700mg±5.0% 769 762 765 764 767


4 Assay 90 % to 110 % 99.99 % 99.89% 99.92 % 99.82% 99.98 %


ON GOING LONG TERM

(REAL TIME)



O

Month

02-02-2015

03

Month

04-05-2015

06 month

04-08-2015

09

month

12

month

18

month

24

month



Minutes for 253rd



White, oblong film coated tablet

with Crystolite` on one side &

Bisected on other side.

White,

oblong film

coated tablet

with

Crystolite`

on one side

& Bisected

on other side

White,

oblong film

coated tablet

with

Crystolite`

on one side

& Bisected

on other side

White,

oblong film

coated tablet

with

Crystolite` on

one side &

Bisected on

other side

- - - -

2 Identification Sofosbuvir must be positive +ve +ve- +ve - - - -

3 Disintegration Time NMT 30 minutes 6.20 minutes 6.3minutes 6.54minutes - - - -

4 Dissolution NLT 85% in 20 minutes 96% 96.4% 93.5% - - - -

4 Assay 90 % to 110 % 100.95 % 99.33% 99.59% - - - -

PRODUCT STABILITY TESTING REPORT CONDUCTED AT 30°C ± 2, RH 65 % ± 5 ON GOING LONG TERM

(REAL TIME)



O

Month

03-03-2015

03

Month

03-06-2015

06

Month

03-09-2015

09

month

12

month

18

month

24

month




on other side.

White,

oblong film

coated tablet

with

Crystolite`

White,

oblong film

coated tablet

with

Crystolite`

White,

oblong film

coated tablet

with

Crystolite`

- - - -



Minutes for 253rd


on one side

& Bisected

on other side

on one side

& Bisected

on other side

on one side

& Bisected

on other side

2 Identification Sofosbuvir must be positive +ve +ve +ve - - - -

3 Disintegration Time NMT 30 minutes 6.20 minutes 6.50 minutes 6.40 minutes - - - -

4 Dissolution NLT 85% in 20 minutes 94.5% 96.8% 94.6% - - - -

4 Assay 90 % to 110 % 100.24% 99.99 % 99.87 % - - - -


ON GOING LONG TERM (REAL TIME)



O

Month

10-03-2015

03

Month

10-06-2015

06

Month

10-09-2015

09

month

12

month

18

month

24

month




on other side.

White,

oblong film

coated tablet

with

Crystolite`

on one side

& Bisected

on other side

White,

oblong film

coated tablet

with

Crystolite`

on one side

& Bisected

on other side

White,

oblong film

coated tablet

with

Crystolite`

on one side

& Bisected

on other side

- - - -



Minutes for 253rd


2 Identification Sofosbuvir must be positive +ve +ve +ve - - - -

3 Disintegration Time NMT 30 minutes 6.08 minutes 56.20

minutes 6.50 minutes - - - -


tablet 700mg±5.0% 764 766 769 - - - -

4 Dissolution NLT 85% in 20 minutes 96.5% 93.6% 96.5% - - - -

4 Assay 90 % to 110 % 100.00% 100.07 % 99.89 % - - - -

Documents / Data provided by the applicants (M/s Crystolite, Islamabad)


1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or GMP certificate of

API manufacturer issued by regulatory authority of country of origin.

Yes (Photocopy

provided)




Yes




Yes

7. Commitment to continue real time stability study till assigned shelf life of the product. Yes

Decision: Mr.Amir Raza, Quality Control Manager presented the data. Registration Board observed that the stability data provided

by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of

registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for

taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central

Drugs Laboratory, Karachi before sale of finished product.

Minutes for 253rd


4. M/s PharmEvo (Pvt) ltd

Drug Zoval tablets (Sofosbuvir) 400 mg

Source Zhejiang Jiangbei Pharmaceutical Pvt Ltd


Real time: 30 C and 75% RH

Time Period Accelerated: 6 months

Real Time: 3 months

Frequency 0, 3, 6 months

Batch Size 400 tablets (Accelerated only)

24500 tablets (Accelerated and RT: 03

months)

No. of Batches 02

Sample Size 200

Batch 1 (Real Time)

Commercial Batch-Long Term Stability Data

Assessment frequency (Months) Initial 1 2 3 6

Date of Testing 03-06-2015 23-07-2015 21-08-2015 21-09-2015

Mode of testing (F=full.) F F F F F Tests (Physical. Chemical) Acceptance Criteria Storage Conditions

(Accelerated)

Appearance Yellow color oblong biconvex

shape film coated tablet plain

from both sides

30◦C ± 2◦C & 75%

RH. ± 5% RH.

Complies Complies Complies Complies

Minutes for 253rd


Identification Positive for Sofosbuvir by

HPLC. The retention time of the

Sample peak in the

chromatogram of the assay

preparation corresponds to that

of the standard preparation as

obtained in the assay.

30◦C ± 2◦C & 75%

RH. ± 5% RH.

Retention time

complies

Retention time

complies

Retention time

complies

Retention time

complies

AVERAGE WEIGHT/TAB 915.0mg ± 5% 30◦C ± 2◦C & 75%

RH. ± 5% RH.

912.7 mg 915.8 mg 921.4 mg 918.4 mg

LENGTH

18.80 – 19.20 mm

30◦C ± 2◦C & 75%

RH. ± 5% RH.

19.14 mm 19.07mm 19.02mm 19.08 mm

WIDTH 8.80 – 9.20 mm 30◦C ± 2◦C & 75%

RH. ± 5% RH.

8.92 mm 9.05 mm 8.96 mm 9.03 mm

THICKNESS 6.30 – 6.90 mm 30◦C ± 2◦C & 75%

RH. ± 5% RH

6.41 mm 6.52 mm 6.49 mm 6.58 mm

DISINTEGRATION NMT 30 mins. 30◦C ± 2◦C & 75%

RH. ± 5% RH

5 mins. 3 mins 4 mins 5 mins

DISSOLUTION

(SOFOSUBVIR )

Not less than 80% after 45

minutes

30◦C ± 2◦C & 75%

RH. ± 5% RH

86.04%

84.78%

95.22%

96.56 %

Assay(SOFOSUBVIR )

(90.0 to 110.0) %

30◦C ± 2◦C & 75%

RH. ± 5% RH

98.45 % 98.53 % 98.32 % 99.37 %



Long term stability study at 300C + 20C and 75% + 5% R.H will be performed for 3 month showed no or little change over time. No significant changes were observed in the physical and

chemical characteristics of the drug product after 3 month.

Accelerated

Commercial Batch-Accelerated Stability Data

Assessment frequency (Months) Initial 1 2 3 6

Date of Testing 03-06-2015 23-07-2015 21-08-2015 21-09-2015

Mode of testing (F=full.) F F F F F

Tests (Physical. Acceptance Criteria Storage Conditions

Minutes for 253rd


Chemical) (Accelerated)

Appearance Yellow color oblong biconvex shape

film coated tablet plain from both

sides

40◦C ± 2◦C & 75%

RH. ± 5% RH.


Identification Positive for Sofosbuvir by HPLC.

The retention time of the Sample

peak in the chromatogram of the

assay preparation corresponds to that



40◦C ± 2◦C & 75%

RH. ± 5% RH.

Retention time

complies

Retention time

complies

Retention time

complies

Retention time

complies

AVERAGE

WEIGHT/TAB

915.0mg ± 5% 40◦C ± 2◦C & 75%

RH. ± 5% RH.

912.7 mg 914.8 mg 920.1 mg 917.3 mg

LENGTH

18.80 – 19.20 mm

40◦C ± 2◦C & 75%

RH. ± 5% RH.

19.14 mm 19.07mm 19.11mm 19.13 mm

WIDTH 8.80 – 9.20 mm 40◦C ± 2◦C & 75%

RH. ± 5% RH.

8.92 mm 8.97 mm 8.95 mm 8.94 mm

THICKNESS 6.30 – 6.90 mm 40◦C ± 2◦C & 75%

RH. ± 5% RH

6.41 mm 6.48mm 6.43mm 6.47mm

DISINTEGRATION NMT 30 mins. 40◦C ± 2◦C & 75%

RH. ± 5% RH

5 mins. 4 mins 5 mins 3 mins

DISSOLUTION

(SOFOSUBVIR )

Not less than 80% after 45 minutes

40◦C ± 2◦C & 75%

RH. ± 5% RH

86.04% 86.44 % 95.47 % 95.85 %

Assay(SOFOSUBVIR )

(90.0 to 110.0) %

40◦C ± 2◦C & 75%

RH. ± 5% RH

98.45 % 100.92 % 99.49 % 100.05 %



Accelerated stability study at 400C + 20C and 75% + 5% R.H will be performed for 3 month showed no or little change over time. No significant changes were observed in the physical and

chemical characteristics of the drug product after 3 month.

Minutes for 253rd


Batch 2:

Lab Scale Batch-Accelerated Stability Data

Assessment frequency (Months) Initial 3 6 Date of Testing 06-11-2014 10-02-2015 12-05-2015 Mode of testing (F=full.) F F F Tests (Physical.

Chemical) Acceptance Criteria Storage Conditions

(Accelerated)

Appearance Yellow color oblong biconvex

shape film coated tablet plain

from both sides

40◦C ± 2◦C & 75% RH.

± 5% RH. Complies Complies Complies

Identification Positive for Sofosbuvir by

HPLC. The retention time of the

Sample peak in the

chromatogram of the assay

preparation corresponds to that



40◦C ± 2◦C & 75% RH.

± 5% RH. Retention time

complies

Retention time

complies

Retention time complies

AVERAGE

WEIGHT/TAB

915.0mg ± 5% 40◦C ± 2◦C & 75% RH.

± 5% RH. 915.4 mg 915.8 mg 915.1 mg

LENGTH

18.80 – 19.20 mm

40◦C ± 2◦C & 75% RH.

± 5% RH. 19.04 mm 19.07mm 19.02 mm

WIDTH 8.80 – 9.20 mm 40◦C ± 2◦C & 75% RH.

± 5% RH. 9.01 mm 9.05 mm 9.03 mm

THICKNESS 6.30 – 6.90 mm 40◦C ± 2◦C & 75% RH.

± 5% RH 6.60 mm 6.68mm 6.65 mm

DISINTEGRATION NMT 30 mins. 40◦C ± 2◦C & 75% RH.

± 5% RH 4 mins. 6 mins 3 mins

DISSOLUTION

(SOFOSUBVIR )

Not less than 80% after 45

minutes

40◦C ± 2◦C & 75% RH.

± 5% RH

98.39%

93.45%

90.07%

Assay(SOFOSUBVIR )

(90.0 to 110.0) %

40◦C ± 2◦C & 75% RH.

± 5% RH 100.50 % 97.44 % 98.88%

Minutes for 253rd




Accelerated stability study at 400C + 20C and 75% + 5% R.H will be performed for 6 month showed no or little change over time. No significant changes were observed in the

physical and chemical characteristics of the drug product after 6 month.

Documents / Data provided by the applicants (M/s PharmEvo, Karachi)


1. COA of API Yes (COA for lab scale batch

not provided)



origin.

Yes (GMP for lab scale batch

not provided)




No (Data of two batches

provided)

5. Documents confirming import of API etc. Invoice of 10 kg API provided.

However, invoice of API for lab

scale batch not provided.



Yes


product.

Yes

Decision: Dr.Iftakhar Jafri, Chief Operating Officer presented the data. He also provided attested copies of GMP of API manufacturer,

Certificate of analysis of the material and invoice of API for lab scale batch. Registration Board observed that the stability data provided by

the firm is not in accordance with the guidelines approved by the Board in 251st meeting as firm has provided staility data for 02 batches.

Therefore, case was deferred till the applicant completes the requisite information in respect of stability studies.

Minutes for 253rd


5. M/s Hilton Pharma, Karachi

Drug Sofohil tablets (Sofosbuvir) 400 mg

Source Zheiejiang jianjbi Pharmaceutical Co, Limited

China (200gm)

Wuxi Sigma Chemical Product Co. Ltd, China (01

kg)

Virupaksha Organics, Telangana, India (500gm)






Batch Size 500 Tablets, 2500 Tablets, 400 Tablets

No. of Batches 03



st meeting of Registration

Board.

Attributes Tested (Batch 1) Real Time

Batch Number :

SOF-192710-1

Date of Manufacturing:

01-10-2014

Proposed Expiry Date:

2 Years Potency : 400mg / Tablet

Kept on stability :

10-10-2014

Container : Alu Alu Foil Blister

Storage Temperature : 30°C ± 2°C

Storage Humidity : 65% ± 5%

Tested / Analyzed For Specification Limits

RESULTS AT TEST STATIONS

Dates Oct-14 Nov-14 Jan-15 Apr-15 Jul-15

Months Initial 1st 3rd 6th 9th

Minutes for 253rd


Description White, Oblong, film

coated tablets

White, Oblong,

film coated tablets

White, Oblong, film

coated tablets

White, Oblong, film

coated tablets

White, Oblong, film

coated tablets

White, Oblong, film

coated tablets

Assay 90 -- 110 % 100.38% 99.89% 99.59% 99.53% 99.46%

Dissolution NLT 85% (Q+5%) in

20 minutes 98% 98% 98% 95% 95%

Degradation products

GS-606965

GS-331007

GS-566500

GS-607669

GS-607670

Phenol

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

Not detected

0.09%

0.03%

0.01%

Not detected

Not detected

Not detected

0.09%

0.01%

0.01%

0.043%

Not detected

Not detected

0.05%

0.03%

0.05%

0.083%

Not detected

Not detected

0.05%

0.04%

0.08%

0.123%

Not detected

Not detected

0.04%

0.03%

0.06%

0.118%

Not detected

Unspecified

Degradation Product NMT 0.2% 0.06% 0.06% 0.05% 0.05% 0.07%

Total degradation

product NMT 0.8% 0.32% 0.180% 0.263% 0.293% 0.317%

Accelerated

Batch Number : SOF-192710-1 Date of Manufacturing: 01-10-2014 Proposed Expiry Date: 2 Years

Potency : 400mg / Tablet

Kept on stability : 10-10-2014 Container : Alu Alu Foil Blister



Tested/Analyzed

For

Specification Limits


Dates Oct-14 Nov-14 Jan-15 Apr-15

Months Initial 1st 3rd 6th

Minutes for 253rd


Description White, Oblong, film

coated tablets

White, Oblong, film

coated tablets

White, Oblong, film

coated tablets

White, Oblong, film

coated tablets

White, Oblong, film coated

tablets

Assay 90 -- 110 % 100.38% 99.51% 98.47% 98.58%

Dissolution NLT 85% (Q+5%) in

20 minutes 98% 98% 98% 94%


GS-606965

GS-331007

GS-566500

GS-607669

GS-607670

Phenol

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

Not detected

0.09%

0.03%

0.01%

Not detected

Not detected

Not detected

0.07%

0.08%

0.01%

0.01%

Not detected

Not detected

0.02%

0.05%

0.10%

0.113%

Not detected

Not detected

0.05%

0.06%

0.10%

0.211%

Not detected

Unspecified Degradation

Product NMT 0.2% 0.06% 0.06% 0.05% 0.04%

Total degradation product NMT 0.8% 0.32% 0.230% 0.333% 0.461%


Batch Number :

SOF-194312-2


31-12-2014



Kept on stability :

09-01-2015






Dates Dec-14 Apr-15 Jul-15

Months Initial 3rd 6th

Minutes for 253rd


Description White, Oblong, film coated

tablets


tablets


tablets White, Oblong, film coated tablets

Assay 90 -- 110 % 100.04% 99.53% 99.46%

Dissolution NLT 85% (Q+5%) in 20

minutes 95% 94% 93%


GS-606965

GS-331007

GS-566500

GS-607669

GS-607670

Phenol

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

Not detected

Not detected

Not detected

0.01%

0.03%

Not detected

Not detected

0.01%

Not detected

Not detected

0.048%

Not detected

Not detected

0.01%

Not detected

Not detected

0.05%

Not detected


Product NMT 0.2% 0.045% 0.044% 0.040%

Total degradation product NMT 0.8% 0.085% 0.102% 0.101%

Accelerated

Batch Number :

SOF-194312-2


31-12-2014



Kept on stability :

09-01-2015






Dates Dec-14 Apr-15 Jul-15

Months Initial 3rd 6th

Minutes for 253rd


Description White, Oblong, film coated

tablets


tablets


tablets White, Oblong, film coated tablets

Assay 90 -- 110 % 100.04% 99.91% 98.83%

Dissolution NLT 85% (Q+5%) in 20

minutes 95% 94% 92%


GS-606965

GS-331007

GS-566500

GS-607669

GS-607670

Phenol

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

Not detected

Not detected

Not detected

0.01%

0.03%

Not detected

Not detected

0.02%

Not detected

0.03%

0.101%

Not detected

Not detected

0.01%

Not detected

0.01%

0.103%

Not detected


Product NMT 0.2% 0.045% 0.054% 0.048%

Total degradation product NMT 0.8% 0.085% 0.205% 0.204%


Batch Number :

SOF-194612-3


17.04.2015



Kept on stability :

20.04.2015 Container : Alu Alu Foil Blister Storage Temperature : 30°C ± 2°C Storage Humidity : 65% ± 5%



Dates Dec-14 Apr-15

Months Initial 3rd

Description White, Oblong, film coated tablets White, Oblong, film coated tablets White, Oblong, film coated tablets

Minutes for 253rd


Assay 90 -- 110 % 100.62% 100.40%

Dissolution NLT 85% (Q+5%) in 20 minutes 100% 99%


GS-606965

GS-331007

GS-566500

GS-607669

GS-607670

Phenol

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Unspecified Degradation Product NMT 0.2% Not detected Not detected

Total degradation product NMT 0.8% Not detected Not detected

Accelerated

Batch Number :

SOF-194612-3


17.04.2015



Kept on stability :

20.04.2015 Container : Alu Alu Foil Blister Storage Temperature : 40°C ± 2°C Storage Humidity : 75% ± 5%



Dates Dec-14 Apr-15

Months Initial 3rd

Description White, Oblong, film coated tablets White, Oblong, film coated tablets White, Oblong, film coated tablets

Assay 90 -- 110 % 100.62% 99.70%

Minutes for 253rd


Dissolution NLT 85% (Q+5%) in 20 minutes 100% 99%


GS-606965

GS-331007

GS-566500

GS-607669

GS-607670

Phenol

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

NMT 0.5%

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Not detected

Unspecified Degradation Product NMT 0.2% Not detected Not detected

Total degradation product NMT 0.8% Not detected Not detected

Documents / Data provided by the applicants

(M/s Hilton Pharma, Karachi)


1. COA of API Yes

2. Approval of API by regulatory authority of country

of origin or GMP certificate of API manufacturer

issued by regulatory authority of country of origin.

Yes

3. Protocols followed for conduction of stability study

and details of tests.

Yes

Minutes for 253rd


4. Data of 03 batches will be supported by attested

respective documents like chromatograms,

laboratory reports, data sheets etc.

Yes

5. Documents confirming import of API etc. Invoices of three batches from three different sources

provided.

500 gram from India (ADC Cleared).

200 gram & 01 Kg from China (custom cleared)

6. All provided documents will be attested (name, sign

and stamp) for ensuring authenticity of data /

documents.

Yes

7. Commitment to continue real time stability study till

assigned shelf life of the product.

Yes

Decision: Mr.Saleem Riaz, Director technical presented the data. He explained that firm has pre-qualified M/s Virupaksha Organics,

Telangana, India as API source and manufactured 03 laboratory scale batches and submitted real time and accelerated stability data for

about 05 months and 15 days. Registration Board observed that the stability data provided by the firm is not in accordance with the

guidelines approved by the Board in 251st meeting as firm has provided staility data for 02 batches. Therefore, case was deferred till the

applicant completes the requisite information in respect of stability studies.

Minutes for 253rd


6. M/s Genome Pharma, Hattar

Drug CHC tablets (Sofosbuvir) 400 mg

Source M/s Beijing Baiao Pharma, China







Batch 2: 400 tab

Batch 3: 400 tab

No. of Batches 03



Registration Board for stability




name/Dosage form CHC-400mg (Sofosbuvir) Tablets Batch No. T-001

Description of pack


28 Tablets in Alu Alu Blister Packed in Card Board Unit

Carton. Batch Size. 400 Tablets

Parameters and tests mentioned As per Product Specifications (Genome Spec‟s) Mfg. Date 07-03-2015

Recommended storage conditions Short term conditions (Accelerated) 40+ 2C, 75 +5RH Exp Date 06-03-2017

Date of initiation & implementation 08-03-2015 (API) lot no.

Sofosbuvir

Minutes for 253rd


Batch No 20150201

Stability No. ST/GP/CHC-001 Source Beijing baiao

Pharmaceuticals Co. Ltd

Accelerated

Tests Specifications

Results: Frequency/Date

0 Month 1 Month 2 Months 3 Months 6 Months

08-03-2015 08-04-2015 08-05-2015 08-06-2015 08-09-2015

Description

White to off-white oblong

unscored biconvex film

coated tablets

Off-white Off-white Off-white Off-white Off-white

Identification Sofosbuvir must be positive Complies Complies Complies Complies Complies

D.T NMT 30 minutes 04minutes 04minutes 04minutes 05minutes 07 minutes

Dissolution NLT 80%(Q) in 45minutes 95.46% 95.38% 95.29% 95.21% 93.87%

Assay 90.0% - 110% 100.43% 100.19% 100.10% 100.15% 99.95 %

Tested by QC Analyst

Sample taken for physical tests = 24 Tabs

Sample taken for Chemical tests = 104 Tabs

Sample taken for Microbiological tests = N/A

Extra samples (if needed) = N/A

Total Sample size (approx) = 128 Tabs

Minutes for 253rd


Checked by QC Manager




Description of pack







Sofosbuvir

Batch No 20150201



Accelerated

Tests Specifications Results: Frequency/Date






Minutes for 253rd



11-03-2015 11-04-2015 11-05-2015 11-06-2015 11-09-2015

Description



coated tablets



D.T NMT 30 minutes 03minutes 03minutes 04minutes 04minutes 06minutes


Assay 90.0% - 110% 100.75% 100.69% 100.61% 100.43% 99.96%





Description of pack







Sofosbuvir

Minutes for 253rd


Batch No 20150201






18-03-2015 18-04-2015 18-05-2015 18-06-2015 18-09-2015

Description



coated tablets



D.T NMT 30 minutes 06minutes 06minutes 06minutes 07minutes 08 minutes


Assay 90.0% - 110% 99.23% 99.22% 99.21% 99.19% 99.0 %






Minutes for 253rd








Description of pack





Recommended storage conditions Long term conditions (Real Time) 30+ 2C, 65 +5RH Exp Date 06-03-2017


Sofosbuvir

Batch No 20150201








Minutes for 253rd




0 Month 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months

08-03-2015 08-06-2015 08-09-2015 08-12-2015 08-03-2016 08-09-2016 08-03-2017

Description



coated tablets

Off-white Off-white Off-white

Identification Sofosbuvir must be

positive Complies Complies Complies

D.T NMT 30 minutes 04minutes 04minutes 04minutes

Dissolution NLT 80%(Q) in 45minutes 95.46% 95.37% 94.65%

Assay 90.0% - 110% 100.43% 100.23% 100.21%







Description of pack





Minutes for 253rd




Sofosbuvir

Batch No 20150201





Initial 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months

11-03-2015 11-06-2015 11-09-2015 11-12-2015 11-03-2016 11-09-2016 11-03-2017

Description



coated tablets





Dissolution NLT 80%(Q) in 45minutes 96.01% 96.28 % 95.08%






Minutes for 253rd


Assay 90.0% - 110% 100.75% 100.51% 100.46%







Description of pack







Sofosbuvir

Batch No 20150201








Minutes for 253rd




0 Month 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months

18-03-2015 18-06-2015 18-09-2015 18-12-2015 18-03-2016 18-09-2016 18-03-2017

Description



coated tablets





Dissolution NLT 80%(Q) in 45minutes 98.73% 98.64% 98.58%

Assay 90.0% - 110% 99.23% 99.21% 99.18%



Minutes for 253rd


Documents / Data provided by the applicants (M/s Genome Pharma, Hattar)


1. COA of API Yes



origin.

Yes (Photocopy provided)




Yes

5. Documents confirming import of API etc. Yes

(ADC cleared)



Yes


product.

No

Decision: Mr. Bakht Zameen, Quality Assurance Manager presented the data. Registration Board observed that the stability data





Minutes for 253rd


7. M/s High-Q Pharma, Karachi

Drug Basovir tablets (Sofosbuvir) 400 mg

Source M/s Jiang Xi Synergy Pharma, China






Batch Size 60 tablets per batch

No. of Batches 03




Stability Data for BASOVIR (Sofosbuvir) 400 mg Tablets

Stability Program Number: STP-048-013

Batch Size: 60 Tablets

Batch Number: TRBBSV-001

Real Time

Test Initial

1

(Month)

3

(Month)

6

(Month)

Description

Complies

Complies

Complies

Complies

Minutes for 253rd






Real Time

Sofosbuvir

by HPLC

(% Label Claim)

101.1

100.9

100.4

100.1

Dissolution

By U.V

94,97,93,

98,101,95

X = 96%

98,102,97

94,98,96

X = 97.5%

99,96,101

93,95,97

X = 96.8%

98,97,99

95,97,94

X = 96.6%

Test

Initial

1

(Month)

3

(Month)

6

(Month)

Description

Complies

Complies

Complies

Complies

Sofosbuvir

by HPLC

(% Label Claim)

100.8

99.9

99.4

99.1

Dissolution

By U.V

96,99,94

94,99,97

X = 96.5%

97,99,96

92,96,97

X = 96%

97,97,95

92,96,94

X = 95%

94,96,94

93,96,95

X = 95%

Minutes for 253rd






Real Time

Test Initial

1

(Month)

3

(Month)

6

(Month)

Description

Complies

Complies

Complies

Complies

Sofosbuvir

by HPLC

(% Label Claim)

100.9

100.8

100.2

100.0

Dissolution

By U.V

98,99,97

98,97,99

X = 98%

100,95,99,

95,95,97

X = 97%

96,95,97

96,94,93

X = 95%

99,94,92

93,93,95

X = 94%

Minutes for 253rd






Accelerated

Test

Initial

1

(Month)

3

(Month)

6

(Month)

Description

Complies

Complies

Complies

Complies

Sofosbuvir

by HPLC

(% Label Claim)

101.1

100.9

99.6

97.7

Dissolution

By U.V

94,97,93,

98,101,95

X = 96%

94,93,95

97,98,94

X = 95%

97,98,92

91,94,92

X = 94%

95,95,97

92,95,93

X = 94%

Minutes for 253rd






Accelerated

Test

Initial

1

(Month)

3

(Month)

6

(Month)

Description

Complies

Complies

Complies

Complies

Sofosbuvir

by HPLC

(% Label Claim)

100.8

101.1

99.2

97.3

Dissolution

By U.V

96,99,94

94,99,97

X = 96.5%

99,95,96

97,95,99

X = 96.8%

99,97,94

93,95,94

X = 95%

95,96,92

95,93,94

X = 94%

Minutes for 253rd






Accelerated

Test

Initial

1

(Month)

3

(Month)

6

(Month)

Description

Complies

Complies

Complies

Complies

Sofosbuvir

by HPLC

(% Label Claim)

100.9

100.2

99.4

98.1

Dissolution

By U.V

98,99,97

98,97,99

X = 98%

96,97,99

95,94,95

X = 96%

97,95,97

95,96,96

X = 96%

97,95,94

92,95,96

X = 95%

Minutes for 253rd


Documents / Data provided by the applicantsm (M/s High-Q Pharma, Karachi)


1. COA of API Yes



origin.

Yes (Photocopy provided)




Yes


(ADC cleared)



Yes


product.

Yes

Decision: No representative of the firm appeared to discuss the data. Registration Board observed that the stability data provided by the

firm is not in accordance with the guidelines approved by the Board in 251st meeting as firm has provided staility data for 02 batches and

clarification is also required regarding number of talets manufactured in a batch and tests performed for staility studies. Therefore, case

was deferred till the applicant completes the requisite information in respect of stability studies.

Minutes for 253rd


8. GLOBAL PHARMA ISLAMABAD

Drug VIRO-C tablets (Sofosbuvir) 400 mg

Source Sulli Pharma Tech, China


Real Time: 30 C and 65% RH


Real Time: 6 months


Batch Size Batch I: 100 tabs

Batch II: 100 tab

Batch III: 250 tabs

No. of Batches 03





WHO/ICH guidelines

ACCELERATED STABILITY STUDY REPORT

Product name / Generic

Name / Dosage form

Viro C Tablets 400mg (Sofosbuvir) Batch No. B#T-004

Description of pack (Container

closure system)

19mm oblong, Biconvex, Off White Coated

Tablets, Packed in HDPE-Bottles with Child

resistant closure & Slicagel Bag.

Batch Size 250 Tablets

Minutes for 253rd


Parameters and tests mentioned As per Product Specifications (Accelerated)

Mfg. Date Dec - 2014

Recommended storage conditions

Short term conditions (Accelerated) 40 +- 2C,

75+-5RH

Long term conditions (Real Time) 30 +

-2C,

65+

-5RH

Exp Date Nov - 2016

Date of initiation

& implementation

17/12/2014

API Lot No. 0049CT29183/2014

Stability No. 15/R&D/135

Approval by : QC Manager:......................................

QA Manager:......................................

Production Manager:...........................

R&D Manager:....................................

Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26

Date of Testing

16-12--

2014

16-03-

2015

16-06-

2015

Mode of testing (F = Full, P = Partial testing)F F P F P F F F F F F F F

Sample taken for physical test = 20 Tablets

Sample taken for Chemical Test = 20 Tablets

Sample taken for Microbiological tests = NA

Extra samples (If Needed) = NA Tot al Sample size 40 x2 = 80 Tab

Minutes for 253rd


Tests(Physical,

Chemical

Microbiological)

Acceptance

Criteria

Storage

Condition

(Accelerated)

Apperance

19mm oblong, biconvex, Off

White Coated

400

C+-20

C 75%

RH+

-5%RH

Complies Complies Complies

Dissolution NLT 75% 40

0

C+-20

C 75% RH+

-5%RH

98.7% 96.2% 95.9%

Identification Positive

400C

+-2

0C 75%

RH+

-5%RH

Positive Positive Positive

Assay 90-110% 400C

+-20C 75% RH

+-

5%RH

101.3% 103.3 103.5%

Analyst signature (after completion of every time line

Tablets

Conclusion by QA (After completion of the study


Product name / Generic Name / Dosage form



closure system)

19mm oblong, Biconvex, Off White

Coated Tablets, Packed in HDPE-

Bottles with Child resistant closure &

Slicagel Bag.


Parameters and tests mentioned

As per Product Specifications

(Accelerated)


Minutes for 253rd



Short term conditions (Accelerated) 40

+- 2C, 75+-5RH


-2C, 65+

-5RH

Exp Date Nov - 2016

Date of initiation & implementation 17/12/2014

API Lot No.

0049CT2918

3/2014



QA Manager:......................................


R&D Manager:....................................


Date of Testing

17-12-

2014

17-03-

2015

17-06-

2015


Tests(Physical,

Chemical

Microbiological)

Acceptance

Criteria

Storage

Condition

(Accelerated)

Apperance

19mm oblong,

biconvex, Off

White Coated

400

C+-20

C 75%

RH+

-5%RH



0

C+-20

C 75% RH+

-5%RH

97.7% 96.0% 95.7%





Minutes for 253rd



400C

+-2

0C 75%

RH+

-5%RH


Assay 90-110% 400C

+-20C 75% RH

+-

5%RH

100.10% 103.5% 103.4%

Analyst signature (after completion of every time line Tablets






closure system)




Slicagel Bag.



As per Product Specifications

(Accelerated)




+- 2C, 75+-5RH


-2C, 65+

-5RH

Exp Date Nov - 2016

Minutes for 253rd


Date of initiation &implementation

17/12/2014

API Lot No.

0049CT2918

3/2014



QA Manager:......................................


R&D Manager:....................................


Date of Testing

17-12--

2014

17-03-

2015

16-06-

2015


Tests(Physical,

Chemical

Microbiological)

Acceptance

Criteria

Storage

Condition

(Accelerated)

Apperance

19mm oblong,

biconvex, Off White Coated

400

C+-20

C 75%

RH+

-5%RH



0

C+-20

C 75% RH+

-5%RH

98.7% 95.8% 95.9%

Identification Positive 400C

+-2

0C 75% Positive Positive Positive





Minutes for 253rd


RH+

-5%RH

Assay 90-110% 400C

+-20C 75% RH

+-

5%RH

100.60% 104.5% 103.9%

Analyst signature (after completion of every time line Tablets


REAL TIME STABILITY STUDY REPORT


Name / Dosage form



closure system)




Slicagel Bag.



As per Product Specifications (Real

Time)




+- 2C, 75+-5RH


-2C, 65+

-5RH

Exp Date Nov - 2016

Date of initiation

& implementation

17/12/2014

API Lot No.

0049CT2918

3/2014

Minutes for 253rd




QA Manager:......................................


R&D Manager:....................................


Date of Testing

16-12--

2014

16-03-

2015

16-06-

2015


Tests(Physical,

Chemical

Microbiological)

Acceptance

Criteria

Storage

Condition

(Real

Time)

Apperance

19mm oblong, biconvex, Off

White Coated

300

C+-20

C

65% RH+

-5%RH


Dissolution NLT 75%

300

C+-20

C

65% RH+

-5%RH

98.7% 94.9% 94.9%


300

C+-20

C

65% RH+

-5%RH


Assay 90-110% 300

C+-20

C 101.33% 103.54% 100.50%




Extra samples (If Needed) = NA Total Sample size 40 x3 = 120 Tab

Minutes for 253rd


65% RH+

-5%RH


Tablets




Name / Dosage form



closure system)




Slicagel Bag.



As per Product Specifications (Real

Time)




+- 2C, 75+-5RH


-2C, 65+

-5RH

Exp Date Nov - 2016

Date of initiation

& implementation

17/12/2014

API Lot No.

0049CT2918

3/2014


Minutes for 253rd


Appro val by : QC Manager:......................................

QA Manager:......................................


R&D Manager:....................................


Date of Testing

16-12--

2014

16-03-

2015

16-06-

2015


Tests(Physical,

Chemical

Microbiological)

Acceptance

Criteria

Storage

Condition

(Real

Time)

Apperance

19mm oblong,

biconvex, Off

White Coated

300

C+-20

C

65% RH+

-5%RH


Dissolution NLT 75%

300

C+-20

C

65% RH+

-5%RH

97.7% 94.6% 94.2%


300

C+-20

C

65% RH+

-5%RH


Assay 90-110%

300

C+-20

C

65% RH+

-5%RH

101.10% 100.14% 100.09%





Minutes for 253rd



Tablets






closure system)




Slicagel Bag.


Parameters and tests mentioned As per Product Specifications (Real

Time) Mfg. Date Dec - 2014



+- 2C, 75+-5RH


-2C, 65+

-5RH

Exp Date Nov - 2016

Date of initiation & implementation 17/12/2014

API Lot No.

0049CT2918

3/2014


Appro val by : QC Manager:...................................... Sample take n for physical test = 10 Tablets

Sample take n for Chemical Test = 10 Tablets

Sample take n for Microbiological tests = NA


Minutes for 253rd


QA Manager:......................................


R&D Manager:....................................


Date of Testing

16-12--

2014

16-03-

2015

16-06-

2015


Tests(Physical,

Chemical

Microbiological)

Acceptance

Criteria

Storage

Condition

(Real

Time)

Apperance

19mm oblong,

biconvex, Off

White Coated

300

C+-20

C

65% RH+

-5%RH


Dissolution NLT 75%

300

C+-20

C

65% RH+

-5%RH

98.7% 95.4% 95.9%


300

C+-20

C

65% RH+

-5%RH


Assay 90-110%

300

C+-20

C

65% RH+

-5%RH

100.60% 100.54% 100.35%


Tablets


Minutes for 253rd



Global Pharma, Islamabad


1. COA of API Yes



origin.

Yes




Yes




Partially attested


product.

Yes

Decision: Mr.Zamir-ul-Hussan and Mr.Anis Iqbal presented the data. Registration Board observed that the stability data provided

by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of




Minutes for 253rd


9. CCL PHARMA ISLAMABAD

Drug Sofos tablets (Sofosbuvir) 400 mg

Source Jianxi Synergy Pharma, China




Real Time: 6 months


Batch Size Batch I: 400 tabs

Batch II: 400 tab

Batch III: 400 tabs

No. of Batches 03





WHO/ICH guidelines




name/Dosage form

Sofos tablets 400mg

Sofosbuvir Batch No. T1 / 15

Description of pack


1260mg film coated, with 19.8mm length, pink oblong

biconvex tablet blistered in 265mm Alu-Alu, in 3x10‟s tablet

packed in printed unit carton along with leaflet.

Batch Size. 400 tablets

Minutes for 253rd


Parameters and tests mentioned In House Mfg. Date 02-2015


Short term conditions (Accelerated) 40°C±2°C,

75% ±5%RH

Long term conditions (Real time) 30°C ± 2°C,

75% ±5 %RH

Exp Date 01-2017

Date of initiation & implementation 10-02-2015 (API) lot no. YF 20150123

Stability No. 024

Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26

Date of Testing 10-2-15 - - 10-5-15 - 10-8-15

Mode of testing(F = full, P = Partial testing) F F F F F F F F F F F F

Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

conditions

(Accelerated)

Description

Pink Oblong

Biconvex film

coated Tablet

40oC ± 2

oC &

75%RH ± 5% RH Complies

- - Complies Complies

Dissolution NLT 75% of

Sofosbuvir

40oC ± 2

oC &

75%RH ± 5% RH 95.29%

- - 93.63% 90.58%

Sample taken for physical tests = 30 tabs.

Sample taken for Chemical tests = 90 tabs.

Extra samples (if needed) = NA

Total Sample size (approx) = 120tabs.

Minutes for 253rd


dissolved in

45min

Identification of

Sofosbuvir

Retention time

of standard

and sample

should be

comparable

40oC ± 2

oC &

75%RH ± 5% RH

Complies

- - Complies

Complies

Assay of

Sofosbuvir 90-110%

40oC ± 2

oC &

75%RH ± 5% RH 103.97%

- - 100.15% 99.13%




Date of Testing 10-2-15 - - 10-5-15 - 10-8-15


Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

conditions

(Real Time)

Description

Pink Oblong

Biconvex film

coated Tablet

30 oC ± 2

oC,



Dissolution

NLT 75% of

Sofosbuvir

dissolved in

45min

30 oC ± 2

oC,

75%RH ±5% RH 95.29%

- - 94.68% 91.47%

Identification of Retention time 30 oC ± 2

oC, Complies

Minutes for 253rd


Sofosbuvir

of standard

and sample

should be

comparable

75%RH ± 5% RH - - Complies Complies

Assay of

Sofosbuvir 90-110%

30 oC ± 2

oC,

75%RH ± 5% RH 103.97%

- - 103.87% 101.51%






name/Dosage form

Sofos tablets 400mg

Sofosbuvir

Batch No. T2 / 15

Description of pack


1260mg film coated, with 19.8mm length, Pink oblong






Short term conditions (Accelerated) 40°C±2°C,

75% ±5%RH

Long term conditions (Real time) 30°C ±2C,

75% ±5 %RH

Exp Date 01-2017

Minutes for 253rd


Date of initiation & implementation 16-02-2015 (API) lot no. YF 20150123

Stability No. 028




Total Sample size (approx) = 120 tabs.

Minutes for 253rd



Date of Testing 16-2-15 - - 16-5-15 - 16-8-15


Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

conditions

(Accelerated)

Description

Pink Oblong

Biconvex film

coated Tablet

40oC ± 2

oC &



Dissolution

NLT 75% of

Sofosbuvir

dissolved in

45min

40oC ± 2

oC &

75%RH ± 5% RH 96.75%

- - 93.85% 90.69%

Identification of

Sofosbuvir

Retention time

of standard

and sample

should be

comparable

40oC ± 2

oC &

75%RH ± 5% RH

Complies


Assay of

Sofosbuvir 90-110%

40oC ± 2

oC &

75%RH ± 5% RH 103.93%

- - 100.15% 99.07%



Minutes for 253rd



Date of Testing 16-2-15 - - 16-5-15 - 16-8-15


Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

conditions

(Real Time)

Description

Pink Oblong

Biconvex film

coated Tablet

30 oC ± 2

oC,



Dissolution

NLT 75% of

Sofosbuvir

dissolved in

45min

30 oC ± 2

oC,

75%RH ±5% RH 96.75%

- - 95.51% 93.77%

Identification of

Sofosbuvir

Retention time

of standard

and sample

should be

comparable

30 oC ± 2

oC,

75%RH ± 5% RH

Complies

- -

Complies

Complies

Assay of

Sofosbuvir 90-110%

30 oC ± 2

oC,

75%RH ± 5% RH 103.93%

- - 103.32% 102.03%



Minutes for 253rd





name/Dosage form

Sofos tablets 400mg

Sofosbuvir Batch No. T3 / 15

Description of pack


1260mg film coated, with 19.8mm length, Pink oblong






Short term conditions (Accelerated) 40°C± 2°C,

75%±5%RH

Long term conditions (Real time) 30°C±2°C,

75%±5 %RH

Exp Date 01-2017


YF 20150123

Stability No. 038




Total Sample size (approx) = 120 tabs.

Minutes for 253rd



Date of Testing 22-2-15 - - 22-5-15 - 22-8-15


Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

conditions

(Accelerated)

Description

Pink Oblong

Biconvex film

coated Tablet

40oC ± 2

oC &



Dissolution

NLT 75% of

sofosbuvir

dissolved in

45min

40oC ± 2

oC &

75%RH ± 5% RH 94.76%

- - 91.13% 89.84%

Identification of

Sofosbuvir

Retention time

of standard

and sample

should be

comparable

40oC ± 2

oC &



Assay of

Sofosbuvir 90-110%

40oC ± 2

oC & 75%RH

± 5% RH 103.29%

- - 99.52% 98.98%



Minutes for 253rd



Date of Testing 22-2-15 - - 22-5-15 - 22-8-15


Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

conditions

(Real Time)

Description

Pink Oblong

Biconvex film

coated Tablet

30 oC ± 2

oC,



Dissolution

NLT 75% of

Sofosbuvir

dissolved in

45min

30 oC ± 2

oC,

75%RH ± 5% RH 94.76%

- - 93.51% 91.28%

Identification of

Sofosbuvir

Retention time

of standard

and sample

should be

comparable

30 oC ± 2

oC,



Assay of

Sofosbuvir 90-110%

30 oC ± 2

oC,

75%RH ± 5% RH 103.29%

- - 101.76% 100.85%



Minutes for 253rd


Documents / Data provided by the applicant

(M/s CCL Pharma, Lahore)


1. COA of API Yes



origin.

Yes




No (raw data not attested)


(By courier)



Partially attested


product.

Yes

Decision: Mr.Umer Saleem and Shahid Anwar presented the data. Registration Board observed that the stability data provided by

the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of




Minutes for 253rd


10. M/s Getz Pharma, Karachi

Drug Sofviget tablets (Sofosbuvir) 400 mg

Source Beijing Kawin Technology Share-Holding Co.

Ltd, China






Two batches: six months

one batch : three months

Batch Size Not provided

No. of Batches 03

Sample Size Not provided



Registration Board for stability studies

Stability Study Data Sheet Product Details:

Product Name / Generic

name / Dosage form Sofviget (Sofosbuvir) Tablets 400mg Batch No. 262DS01

Description of pack


400mg Yellow colored oblong shaped film coated

tablets, packed in 28 x 1 HDPE bottle, further packed

in secondary carton. Batch Size. 400 tablets

Parameters and test

mentioned

Appearance: Yellow colored oblong shaped film

coated tablets, both sides plain.

Disintegration Time: Not more than 30 minutes. Mfg. Date September 2014

Minutes for 253rd


Identification: The retention time of the major


Assay preparation corresponds to

that of the Standard preparation as

obtained in the Assay.

Dissolution: Not less than 75% (Q); (Q + 5% =

80%)

Assay: (90.0 – 110.0)%

Total Aerobic Not more than 1000 cfu/gm

Microbial Count:

Total Yeast & Mold Not more than 100 cfu/gm

Count:

Escherichia coli: Must be absent / 10gm

Recommended storage

conditions

Accelerated condition: 40°C ± 2°C & 75% ± 5%RH

Real time condition: 30°C ± 2°C & 75% ± 5%RH Exp. Date September 2016


Implementation September 2014 (API) lot no. HM174C00520140812

Stability No. FS-837

Sample taken for physical tests = 40


Sample taken for Microbiological tests = 10

Extra samples (if needed) = -

Total Sample size (approx) = 50

Minutes for 253rd



Date of Testing Sep-14 Dec-14 Mar-15

Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F

Tests (Physical,

Chemical,

Microbiological) Acceptance Criteria

Storage

conditions

(Accelerated)

Appearance Yellow colored oblong shaped film coated

tablets, both sides plain.

Complies

40°C ± 2°C &

75% ± 5%RH - - Complies - Complies

Disintegration Time

Not more than 30 minutes.

1 min

40°C ± 2°C & 75% ± 5%RH

- - 2 min - 2 min

Identification

The retention time of

the major peak in the

chromatogram of the Assay preparation

corresponds to that of

the Standard preparation as obtained in the

Assay.

Complies

40°C ± 2°C & 75% ± 5%RH

- - Complies - Complies

Dissolution Not less than 75% (Q); (Q + 5% = 80%)

91.801%

40°C ± 2°C &

75% ± 5%RH - - 91.040% - 96.749%

Assay (90.0 – 110.0)%

96.057%

40°C ± 2°C & 75% ± 5%RH

- - 97.295% - 96.760%

Total Aerobic

Microbial Count

Not more than 1000 cfu/gm

40°C ± 2°C &

75% ± 5%RH 0.00

cfu/g - - - -

0.00

cfu/g

Total Yeast &

Mold Count

Not more than 100

cfu/gm 40°C ± 2°C & 75% ± 5%RH

0.00

cfu/g - - - -

0.00

cfu/g

Escherichia coli Must be absent / 10gm 40°C ± 2°C & 75% ± 5%RH

Complies - - - - Complies

Analyst signature

Conclusion by QA

Minutes for 253rd



Date of Testing Sep-14 Dec-14 Mar-15 Jun-15


Tests (Physical,

Chemical,


Storage

conditions

(Accelerated)

Appearance Yellow colored oblong shaped film coated


Complies

30°C ± 2°C &

75% ± 5%RH - - Complies - Complies Complies

Disintegration Time

Not more than 30 minutes.

1 min

30°C ± 2°C & 75% ± 5%RH

- - 1 min - 2 min 1 min

Identification






Assay.

Complies

30°C ± 2°C & 75% ± 5%RH

- - Complies - Complies Complies

Dissolution Not less than 75% (Q); (Q + 5% = 80%)

91.801%

30°C ± 2°C &

75% ± 5%RH - - 96.670% - 96.626% 90.819%

Assay (90.0 – 110.0)%

96.057%

30°C ± 2°C & 75% ± 5%RH

- - 97.480% - 96.475% 101.054%

Total Aerobic

Microbial Count

Not more than 1000 cfu/gm

30°C ± 2°C &

75% ± 5%RH 0.00

cfu/g - - - - - -

Total Yeast &

Mold Count

Not more than 100

cfu/gm 30°C ± 2°C & 75% ± 5%RH

0.00

cfu/g - - - - - -


Complies - - - - - --

Analyst signature

Conclusion by QA

Minutes for 253rd





Description of pack





Parameters and test

mentioned



Disintegration Time: Not more than 30 minutes.







80%)

Assay: (90.0 – 110.0)%


Microbial Count:


Count:


Mfg. Date December 2014

Recommended storage

conditions


Real time condition: 30°C ± 2°C & 75% ± 5%RH Exp. Date December 2016


Implementation December 2014 (API) lot no. HM174C00520140812

Stability No. FS-879




Minutes for 253rd





Date of Testing Dec-14 Mar-15 Jun-15


Tests (Physical,

Chemical,


Storage

conditions

(Accelerated)

Appearance Yellow colored oblong shaped film coated tablets,

both sides plain.

Complies

40°C ± 2°C & 75%

± 5%RH - - Complies - Complies

Disintegration Time Not more than 30 minutes.

5 min

40°C ± 2°C & 75%

± 5%RH - - 3 min - 5 min

Identification

The retention time of the

major peak in the chromatogram of the

Assay preparation

corresponds to that of the Standard preparation as


Complies

40°C ± 2°C & 75% ± 5%RH


Dissolution Not less than 75% (Q); (Q

+ 5% = 80%)

93.879%

40°C ± 2°C & 75%

± 5%RH - - 97.105% - 97.038%

Assay (90.0 – 110.0)%

95.822%

40°C ± 2°C & 75%

± 5%RH - - 97.830% - 97.754%

Minutes for 253rd


Total Aerobic

Microbial Count

Not more than 1000

cfu/gm 40°C ± 2°C & 75%

± 5%RH 0.00 cfu/g - - - -

0.00

cfu/g

Total Yeast & Mold

Count Not more than 100 cfu/gm 40°C ± 2°C & 75%

± 5%RH 0.00 cfu/g - - - -

0.00

cfu/g


Complies - - - - Complies

Analyst signature

Conclusion by QA

Minutes for 253rd



Date of Testing Dec-14 Mar-15 Jun-15


Tests (Physical,

Chemical,


Storage

conditions

(Accelerated)

Appearance

Yellow colored oblong

shaped film coated


Complies

30°C ± 2°C & 75% ± 5%RH


Disintegration

Time

Not more than 30

minutes.

5 min

30°C ± 2°C & 75% ± 5%RH

- - 3 min - 5 min

Identification



chromatogram of the

Assay preparation



Assay.

Complies

30°C ± 2°C &

75% ± 5%RH - - Complies - Complies

Dissolution Not less than 75% (Q);

(Q + 5% = 80%)

93.879%

30°C ± 2°C &

75% ± 5%RH - - 96.238% - 94.805%

Assay (90.0 – 110.0)%

95.822%

30°C ± 2°C & 75% ± 5%RH

- - 97.895% - 99.785%

Total Aerobic

Microbial Count

Not more than 1000

cfu/gm 30°C ± 2°C &

75% ± 5%RH 0.00

cfu/g - - - - -

Total Yeast &

Mold Count

Not more than 100

cfu/gm 30°C ± 2°C & 75% ± 5%RH

0.00

cfu/g - - - - -


Complies - - - - -

Analyst signature

Conclusion by QA

Minutes for 253rd





Description of pack





Parameters and test

mentioned



Disintegration Time: Not more than 30 minutes.







80%)

Assay: (90.0 – 110.0)%


Microbial Count:


Count:


Mfg. Date April 2015

Recommended storage

conditions


Real time condition: 30°C ± 2°C & 75% ± 5%RH Exp. Date April 2016


Implementation April 2015 (API) lot no. 2141206

Stability No. FS-056-15


Minutes for 253rd







Date of Testing Apr-15 Aug-15


Tests (Physical,

Chemical,


Storage

conditions

(Accelerated)

Appearance


shaped film coated


Complies

40°C ± 2°C & 75% ± 5%RH

- - Complies

Disintegration

Time

Not more than 30

minutes.

2 min

40°C ± 2°C & 75% ± 5%RH

- - 3 min

Identification

The retention time of the major peak in the

chromatogram of the

Assay preparation corresponds to that of

the Standard preparation

as obtained in the

Assay.

Complies

40°C ± 2°C &

75% ± 5%RH - - Complies


(Q + 5% = 80%)

93.804%

40°C ± 2°C &

75% ± 5%RH - - 88.759%

Assay (90.0 – 110.0)%

97.798%

40°C ± 2°C & 75% ± 5%RH

- - 96.231%

Minutes for 253rd


Total Aerobic

Microbial Count

Not more than 1000

cfu/gm 40°C ± 2°C & 75% ± 5%RH

0.00

cfu/g - - -

Total Yeast &

Mold Count

Not more than 100

cfu/gm 40°C ± 2°C & 75% ± 5%RH

0.00

cfu/g - - -


Complies - - -

Analyst signature

Conclusion by QA


Date of Testing Apr-15 Aug-15


Tests (Physical,

Chemical,


Storage

conditions

(Accelerated)

Appearance


shaped film coated


Complies

30°C ± 2°C & 75% ± 5%RH

- - Complies

Disintegration

Time

Not more than 30

minutes.

2 min

30°C ± 2°C & 75% ± 5%RH

- - 2 min

Identification






Assay.

Complies

30°C ± 2°C &

75% ± 5%RH - - Complies


(Q + 5% = 80%)

93.804%

30°C ± 2°C &

75% ± 5%RH - - 91.359%

Assay (90.0 – 110.0)%

97.798%

Minutes for 253rd


30°C ± 2°C &

75% ± 5%RH - - 100.691%

Total Aerobic

Microbial Count

Not more than 1000

cfu/gm 30°C ± 2°C &

75% ± 5%RH 0.00

cfu/g - - -

Total Yeast &

Mold Count

Not more than 100

cfu/gm 30°C ± 2°C & 75% ± 5%RH

0.00

cfu/g - - -


Complies - - -

Analyst signature

Conclusion by QA

Documents / Data provided by the applicants (M/s Getz Pharma, Karachi)


1. COA of API Yes



origin.

Yes




Yes

(Third batch : 3months

data)




Yes


product.

Yes

Decision: Mr. Sultan Ghani, Director QA submitted up dated stability data for 3rd

batch. Registration Board observed that the stability data

provided by the firm for 3rd

batch is not for 06 months and thus not in accordance with the guidelines approved by the Board in 251st

meeting. Therefore, case was deferred till the applicant completes the requisite information in respect of stability studies

Minutes for 253rd


11. M/s AGP, Karachi

(Manufactured by: M/s Mylan Laboratories, Ltd, F4 &F 12, MIDC, Malegaon, Sinnar, Nashik-422113, Maharahtra, India.)

Firm M/s AGP, Karachi

Drug Myhep 400mg

Source M/s Mylan Laboratories, India

Storage Condition Accelerated and Real Time (Zone IV-A)

Time Period 06 Months

Frequency 03 Months Interval

Batch Size 18000

No. of Batches 03


Meeting M-251st

Scanned copy (Notarized) of sole agency agreement provided.

MYLAN LABORATORIES LIMITED

F-4 & F-12, Malegaon MIDC, Sinnar,

Nashik - 422 113, Maharashtra, India.

ACCELERATED STORAGE CONDITION - STABILITY STUDY DATA Product Sofosbuvir Tablets 400 mg Market REXP

Strength 400mg Batch Size 18000 Tablets

Batch No. 2008369 Pack 28'S HDPE

Mfg. Date Jan-2015 Protocol No. EBSP-SFB000T-001 -00

Exp. Date Dec-2016 STPNo. FPPSFB151R

Date In Jan 23,2015 Stability Site Mylan Laboratories Ltd. Nashik

Storage Condition 40°C ± 2°C /75% ± 5% RH Batch Type Exhibit

S. Test(s) Specification 0Day(s) 1Month(s) 3Month(s) 5Month(s) 6Month(s)

Minutes for 253rd


No. MLNEST1501031 MLNEST1501669 MLNEST1503609 MLNEST1506170 MLNEST1507169

1 Description

Yellow colored, capsule

shaped biconvex beveled

edge film coated tablet

debossed with "SF400"

on one side of the tablet and "M" on the other

side.






side.






side.






side.




debossed with "SF400"'


side.






side.

2 Assay (By HPLC)

360.00 - 420.00 mg/tablet 90.0- 105.0%

w/w

In mg:402.46 mg

In % : 100.6 % w/w

In mg:400.61 mg

In % : 100.2 % w/w

In mg:409.83 mg

In % : 102.5 % w/w

In mg:402.43 mg

In % : 100.6% w/w

In mg:405.37 mg

In % : 101.3 % w/w

3 Dissolution (By UV) Not less than 80% (Q =

75%) in 15 minutes.

Min:96 %

Max:98 % Avg: 97 %

Min:97 %

Max:98 % Avg: 97 %

Min:95 %

Max:96 % Avg: 95 %

4 Dissolution Profile

(By UV)

Not less than 80% (Q =

75%) in 15 minutes.

Min:96 %

Max:98 % Avg: 97 %

Min:97 %

Max:99 % Avg: 98 %

5 Related

(Long term Storage Conditions) S.

No. Test(s) Specification

0Day(s)

MLNEST1501031

3Month(s)

MLNEST1503610

6Month(s)

MLNEST1507170

1 Description

Yellow colored, capsule shaped

biconvex beveled edge film

coated tablet debossed with

"SF400" on one side of the tablet

and "M" on the other side.
















2 Assay (By HPLC) 360.00 - 420.00 mg/tablet 90.0 -

105.0% w/w

In mg:402.46 mg

In % : 100.6% w/w

In mg:410.68 mg

In % : 102.7 % w/w

In mg:404.43 mg

In % : 101.1 % w/w

3 Dissolution (By UV) Not less than 80% (Q = 75%) in

15 minutes.

Min:96 %

Max:98 %

Avg: 97 %

-- --

4 Dissolution Profile (By UV) Not less than 80% (Q = 75%) in

15 minutes. --

Min:95 %

Max:97 %

Avg: 96 %

Min:98 %

Max:99 %

Avg: 98 %

5 Related Substances (By

Minutes for 253rd


MYLAN LABORATORIES LIMITED F-4 & F-12, Malegaon MIDC, Sinnar,

Nashik - 422 113, Maharashtra, India.

ACCELERATED STORAGE CONDITION - STABILITY STUDY DATA Product Sofosbuvir Tablets 400 mg Market REXP




Exp. Date Dec-2016 STP No. FPPSFB151R

Date In Jan 23, 2015 Stability Site Mylan Laboratories Ltd. Nashik

Storage Condition 40°C ± 2°C 175% ± 5% RH Batch Type Exhibit

S.


0Day(s)

MLNEST1501032

1Month(s)

MLNEST1501670

3Month(s)

MLNEST1503611

5Month(s)

MLNEST1506171

6Month(s)

MLNEST1507171

1 Description





on one side of the tablet

and "M" on the other

side.







side.







side.







side.







side.







side.

2 Assay (By HPLC)

360.00 - 420.00

mg/tablet 90.0 - 105.0%

w/w

In mg:405.50 mg

In % : 101.4 % w/w

In mg:400.54 mg

In % : 100.1 % w/w

In mg:410.99 mg

In % : 102.7% w/w

In mg:400.27 mg

In % : 100.1 % w/w

In mg:409.42 mg

In % : 102.4% w/w

3 Dissolution (By

UV)


75%) in 15 minutes.

Min:99 %

Max: 100%

Avg : 99 %

Min:97 %

Max:98 %

Avg: 98 %

Min:94 %

Max:96 %

Avg: 95 %


(By UV)


75%) in 15 minutes.

Min:97 %

Max:99 %

Avg: 98 %

Min:97 %

Max:98 %

Avg: 98 %

5 Related

Minutes for 253rd


(Long Term Storage Conditions)

S.


0Day(s)

MLNEST1501032

3Month(s)

MLNEST1503612

6Month(s)

MLNEST1507172

1 Description


biconvex beveled edge film coated

tablet debossed with "SF400" on

one side of the tablet and "M" on

the other side.





the other side.





the other side.





the other side.


105.0% w/w

In mg:405.50 mg

In % : 101.4 % w/w

In mg:413.67 mg

In % : 103.4 % w/w

In mg:407.25 mg

In % : 101.8% w/w

3 Dissolution (By

UV)

Not less than 80% (Q = 75%) in 15

minutes.

Min:99 %

Max: 100%

Avg: 99 %

4 Dissolution Profile (By UV) Not less than 80% (Q = 75%) in 15

minutes.

Min:97 %

Max:98 %

Avg: 97 %

Min:97 %

Max:99 %

Avg: 99 %

5 Related

Substances (By

MYLAN LABORATORIES LIMITED F-4 & F-12, Malegaon MIDC, Sinnar,

Nashik - 422 113, Maharashtra, India. ACCELERATED STORAGE CONDITION - STABILITY STUDY DATA

Product Sofosbuvir Tablets 400 mg Market REXP




Exp. Date Dec-2016 STP No. FPPSFB151R

Date In Jan 23, 2015 Stability Site Mylan Laboratories Ltd. Nashik

Storage Condition 40°C ± 2°C /75% ± 5% RH Batch Type Exhibit

S.


0Day(s)

MLNEST1501030

1Month(s)

MLNEST1501668

3Month(s)

MLNEST1503607

5Month(s)

MLNEST1506169

6Month(s)

MLNEST1507167

1 Description Yellow colored, capsule Yellow colored, capsule Yellow colored, capsule Yellow colored, capsule Yellow colored, capsule Yellow colored, capsule

Minutes for 253rd







side.






side.






side.






side.






side.






side.

2 Assay (By HPLC)

360.00 - 420.00

mg/tablet 90.0 - 105.0%

w/w

In mg:402.60 mg

In % : 100.7 % w/w

In mg:402.35 mg

In % : 100.6 % w/w

In mg:404.12 mg

In % : 101.0 % w/w

In mg:401.94 mg

In % : 100.5 % w/w

In mg:403.73 mg

In % : 100.9 % w/w

3 Dissolution (By

UV)


75%) in 15 minutes.

Min:94 %

Max:95 %

Avg: 95 %

Min:97 %

Max:98 %

Avg: 97 %

--

Min:94 %

Max:96 %

Avg: 95 %

--


(By UV)


75%) in 15 minutes. -- --

Min:94 %

Max:98 %

Avg: 96 %

--

Min:98 %

Max:99 %

Avg: 99 %

5 Related

(Long Term Storage Conditions) S.


0Day(s)

MLNEST1501030

3Month(s)

MLNEST1503607 6Month(s) MLNEST1507168

1 Description






















105.0% w/w

In mg:402.60 mg

In % : 100.7% w/w

In mg:410.08 mg

In % : 102.5 % w/w

In mg:402.32 mg

In % : 100.6 % w/w

3 Dissolution (By UV) Not less than 80% (Q = 75%) in

15 minutes.

Min:94 %

Max:95 %

Avg: 95 %

-- --

Minutes for 253rd


4 Dissolution Profile (By UV) Not less than 80% (Q = 75%) in

15 minutes. --

Min:94 %

Max:98 %

Avg: 96 %

Min:98 %

Max:99 %

Avg: 99 %

5 Related Substances (By

Documents / Data provided by the applicant (M/s AGP, Karachi )


1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or GMP certificate of

API manufacturer issued by regulatory authority of country of origin.

Yes (M/s Mylan

Laboratories, India)




Yes

5. Documents confirming import of API etc. NA (Imported as FPP)



Yes


product.

Yes

Decision: Mr.Qamar Nafees, Director QA of the firm presented that M/s Mylan Laboratories Limited is a licensee of M/s Gillead

Laboratories (innovator of the product) and product has been developed after complete technology transfer from aforementioned company.

Moreover, M/s AGP has additionally provided bio-equivalence studies and data has been presented with registration dossier. Registration

Board discuused reference sent by PPMA for not granting registrations to Sofosbuvir 400mg Tablets from India as local pharmaceutical

manufacturers can manufacture it. The Board deliberated the request in detail and also discussed that parameters for grant of registration

are safety, efficacy and quality and application by M/s AGP qualifies for approval / grant of registration. Members were also of the view that

Import Policy Order 2012-2015, Ministry of Commerce don’t restrict import of Sofosbuvir 400 mg tablets from India. However, keeping in

view presentation made by PPMA, the Board decided to get opinion of Ministry of Commerce regarding importability of Sofosbuvir 400 mg

tablets from India for updated status as mentioned in PPMA’s letter.

Minutes for 253rd


12. TABROS PHARMA KARACHI

Drug VIBRENTAL tablets (Sofosbuvir) 400 mg

Source M/s Xiamen Halosyntech China





Frequency 0, 1,2, 3, 6 months

Batch Size 166/ batch

No. of Batches 03




STABILITY STUDY PROTOCOL


Product name / Genric

name/Dosage form VIBRENTA TABLET (Sofosbuvir Tablet) Batch No. EXP-001

Description of pack


400mg Film Coated white oblong tablet blistered in Alu-

alu foil packed in prined unit carton. Batch Size 166 Tablets

Parameters and tests

mentioned As per Product Specifications Mfg. Date Nov-2014

Recommended storage

conditions

Short term condictions (Accelerated) 40± 2°C, 75±5% RH

Long term condictions (Real Time) 30± 2°C, 65±5% RH Exp. Date Oct-2016

Date of initiation & 05/11/14 (API) Lot no. 141001

Minutes for 253rd


implementation

Stability No. TAB-RND-001/14

Sample taken for physical tests = 50 Tablets

Sample taken for Chemical tests = 50 Tablets

Sample taken for Microbiological

tests = N/A

Extra Samples (if needed) = 100 Tablets

Total Sample size (approx) = 200 Tablets

STABILITY STUDY DATA SHEET


Product name / Genric


Description of pack


400mg Film Coated white oblong tablet blistered in Alu-alu foil

packed in prined unit carton. Batch Size 1000 Tablets



Recommended storage Short term condictions (Accelerated) 40± 2°C, 75±5% Exp. Date Oct-2016

Minutes for 253rd


conditions RH

Long term condictions (Real Time) 30± 2°C, 65±5% RH


implementation 05/11/14 (API) Lot no. 141001





tests = N/A




Date of Testing Nov-14 Dec-14 Jan-15 Feb-15 May-15

Mode of Testing (F = full, P = Partial testing) F P F P F F F F F F F F

Tests Acceptance

Criteria

Storage

conditions

(Accelerated)

(Physical,

Chemical,

Microbiological)

Minutes for 253rd


Appearance

White film

coated oblong

Tablet

40°C± 2°C &

75%±5% RH Comply

Comply Comply Comply Comply

Average

Weight 615.0 mg ±

5.0% 40°C± 2°C &

75%±5% RH 625 mg

624 mg 623 mg 626 mg 625 mg

Disintegration

Time

NMT 30

Minutes

40°C± 2°C &

75%±5% RH 4:10

4:20 3:55 4:26 4:50

Dissolution

Test NLT 80.0%

40°C± 2°C &

75%±5% RH 86.68%

96.46% 94.19% 96.79% 97.18%

Assay

(Sofosbuvir)

(Sofosbuvir)

90.0% ---

110.0%

40°C± 2°C &

75%±5% RH 100.22%

100.35% 100.01% 100.12% 99.20%

Analyst signature (after completion of every

time line)


Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Accelerated conditions (40±2°C) & RH 75±5%. The product found stable for 6 Months

Minutes for 253rd



Date of Testing Nov-14 Feb-15 May-

15


Tests Acceptance

Criteria

Storage

conditions

(Real Time)

(Physical,

Chemical,

Microbiological)

Appearance

White film

coated oblong

Tablet

30°C± 2°C &

65%±5% RH

Compl

y

Compl

y

Compl

y

Average

Weight 615.0 mg ±

5.0% 30°C± 2°C &

65%±5% RH 625 mg

624 mg 623

mg

Disintegration

Time

NMT 30

Minutes

30°C± 2°C &

65%±5% RH 4:01

3:55 4:15

Dissolution

Test NLT 80.0%

30°C± 2°C &

65%±5% RH 86.68%

85.10% 84.11

%

Assay

(Sofosbuvir)

(Sofosbuvir)

90.0% ---

110.0%

30°C± 2°C &

65%±5% RH

100.22

%

100.02

%

89.90

%

Minutes for 253rd


Analyst signature (after completion of every time

line)


Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Real Time conditions (30±2°C) & RH 65±5%. The product found stable for 6

Months

STABILITY STUDY PROTOCOL




Description of pack



alu foil packed in prined unit carton. Batch Size 1000 Tablets



Recommended storage

conditions

Short term condictions (Accelerated) 40± 2°C, 75±5%

RH

Long term condictions (Real Time) 30± 2°C, 65±5%

RH

Exp. Date Oct-2016




Minutes for 253rd





tests = N/A



STABILITY STUDY DATA SHEET 1.0 Product details:



Description of pack



alu foil packed in printed unit carton. Batch Size 1000 Tablets



Recommended storage

conditions

Short term condictions (Accelerated) 40± 2°C, 75±5%

RH

Long term condictions (Real Time) 30± 2°C, 65±5%

RH

Exp. Date Oct-2016

Minutes for 253rd








tests = N/A



Assessment frequency (Months) Initial 1 2 3 4 6 8 12 1

6

2

0

2

4

2

6

Date of Testing Nov-14 Dec-14 Jan-15 Feb-15 May-

15

Mode of Testing (F = full, P = Partial

testing) F P F P F F F F F F F F

Tests Acceptan

ce

Storage

conditions

(Physical, Chemical, Microbiological)

Minutes for 253rd


Criteria (Accelerat

ed)

Appearance

White

film

coated

oblong

Tablet

40°C±

2°C &

75%±5%

RH

Compl

y

Compl

y

Compl

y

Compl

y

Comp

ly

Average Weight 615.0 mg

± 5.0%

40°C±

2°C &

75%±5%

RH

624

mg

625

mg

620

mg

621

mg

626

mg

Disintegration Time NMT 30

Minutes

40°C±

2°C &

75%±5%

RH

4:03

4:35 4:44 4:28 4:11

Dissolution Test NLT

80.0%

40°C±

2°C &

75%±5%

RH

88.10

%

95.36

%

94.21

%

96.33

%

96.67

%

Assay

(Sofosbuvir)

(Sofosbuv

ir)

90.0% ---

110.0%

40°C±

2°C &

75%±5%

RH

101.18

%

100.69

%

100.70

%

100.27

%

99.10

%

Analyst signature (after completion of

every time line)

Conclusion by QA (after completion of

the study):

Stability studies of Sofosbuvir (400mg)

Vibrenta Tablet was conduct in

Accelerated conditions (40±2°C) & RH

Minutes for 253rd


75±5%. The product found stable for 6

Months


Date of Testing Nov-14 Feb-15 May-15


Tests Acceptance

Criteria

Storage

conditions

(Real Time)

(Physical,

Chemical,

Microbiological)

Appearance

White film

coated oblong

Tablet

30°C± 2°C &

65%±5% RH Comply

Comply Comply

Average

Weight 615.0 mg ±

5.0% 30°C± 2°C &

65%±5% RH 624 mg

623 mg 625 mg

Disintegration

Time

NMT 30

Minutes

30°C± 2°C &

65%±5% RH 4:03

3:50 4:02

Dissolution

Test NLT 80.0%

30°C± 2°C &

65%±5% RH 88.10%

87.22% 86.12%

Minutes for 253rd


Assay

(Sofosbuvir)

(Sofosbuvir)

90.0% ---

110.0%

30°C± 2°C &

65%±5% RH 101.18%

101.00% 99.98%


time line)


Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Real Time conditions (30±2°C) & RH 65±5%. The product found stable for 6 Months

STABILITY STUDY PROTOCOL Product details:



Description of pack



packed in printed unit carton. Batch Size 1000 Tablets



Recommended storage

conditions

Short term conditions (Accelerated) 40± 2°C, 75±5% RH

Long term conditions (Real Time) 30± 2°C, 65±5% RH Exp. Date Oct-2016




Minutes for 253rd





tests = N/A



STABILITY STUDY DATA SHEET




Description of pack



packed in printed unit carton. Batch Size 1000 Tablets

Parameters and tests mentioned As per Product Specifications Mfg. Date Nov-2014

Recommended storage conditions Short term conditions (Accelerated) 40± 2°C, 75±5% RH

Long term conditions (Real Time) 30± 2°C, 65±5% RH Exp. Date Oct-2016




Minutes for 253rd








Date of Testing Nov-14 Dec-14 Jan-15 Feb-15 May-

15


Tests

Acceptance

Criteria

Storage

conditions

(Accelerated)

(Physical,

Chemical,

Microbiological

)

Appearance

White film

coated oblong

Tablet

40°C± 2°C &

75%±5% RH

Compl

y

Compl

y

Compl

y

Compl

y

Compl

y

Average 615.0 mg ± 40°C± 2°C & 625 mg

Minutes for 253rd


Weight 5.0% 75%±5% RH 624.5

mg 625 mg 623 mg

624

mg

Disintegration

Time

NMT 30

Minutes

40°C± 2°C &

75%±5% RH 4:02

4:25 4:55 4:01 4:19

Dissolution

Test NLT 80.0%

40°C± 2°C &

75%±5% RH

88.10

%

95.16% 94.15

%

97.13

%

98.06

%

Assay

(Sofosbuvir)

(Sofosbuvir)

90.0% ---

110.0%

40°C± 2°C &

75%±5% RH

100.67

%

100.48

%

100.48

%

100.06

%

99.19

%


time line)


Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Accelerated conditions (40±2°C) & RH 75±5%. The product found stable for

6 Months


Date of Testing


Tests Acceptance Storage

Minutes for 253rd


(Physical,

Chemical,

Microbiological)

Criteria conditions

(Real Time)

Appearance

White film

coated oblong

Tablet

30°C± 2°C &

65%±5% RH

Compl

y

Compl

y

Compl

y

Average

Weight 615.0 mg ±

5.0% 30°C± 2°C &

65%±5% RH 625 mg

624 mg 622

mg

Disintegration

Time

NMT 30

Minutes

30°C± 2°C &

65%±5% RH 4:20

4:13 4:32

Dissolution

Test NLT 80.0%

30°C± 2°C &

65%±5% RH 88.10%

87.13% 85.47

%

Assay

(Sofosbuvir)

(Sofosbuvir)

90.0% ---

110.0%

30°C± 2°C &

65%±5% RH

100.67

%

100.53

%

99.76

%

Analyst signature (after completion of every time

line)


Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Real Time conditions (30±2°C) & RH 65±5%. The product found stable for 6

Months

Minutes for 253rd



M/s Tabros, Karachi


1. COA of API Yes



origin.

No (GMP certificate of the

manufacturer is different

from the COA provided/

API imported)

Firm submitted that Ximen

Halosyntech China is

located in Benbhu BBCA

Tushan Pharmaceutical

China, who is GMP owner

and contract manufacturing

for plant for Xiamen.

Xiamen has contract

manufacturing with

Bengbbu Tushan

.


Minutes for 253rd




Yes

5. Documents confirming import of API etc. Only 200 grams of API

imported (By courier).

Quantity of API does not

relate to the claimed batch

size.



Yes


product.

Yes

Decision: Mr.Faisal Abbas, Quality Assurance Manager appeared befor Registration Board and clarified that M/s Ximen

Halosyntech China is located in Benbhu, China and Benbhu Tushan Pharmaceutical China is GMP owner and contract

manufacturing for plant for Xiamen. He aprovided COA and GMP certificate for manufacturer of the API i.e. Benbhu Tushan

Pharmaceutical China. He further informed that batch size of 1000 tablets per batch was mentioned mistakenly in earlier stability

data. The actual btach size is 166 tablets per batch and submitted copy of revised data of the batch. Keeping in view data submitted,

Registration Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform

concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first

commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product.

Minutes for 253rd


13. GLITZ PHARMA ISLAMABAD

Drug Sofosvir tablets (Sofosbuvir) 400 mg

Source M/s Jianxi Synergy Pharma, China





Frequency 0, 1,2, 3 months

Batch Size 1. 1500 2. 500, 3. 500 batch

No. of Batches 03




Minutes for 253rd


Product Details

Product name/ Generic name/

Dosage form Sofosvir (Sofosbuvir) 400mg Tablets Batch No TT-01

Description of pack

(container closure system) Blister Pack Bat size 1500 Tablets


mentioned Description, Identification, Disintegration, Dissolution & Assay Mfg. Date 07-2015

Recommended storage

conditions

Short term conditions (Accelerated) 40◦C ±2

◦C, 75%±5% RH

Long term conditions (Real Time) 30◦C ±2

◦C, 65%±5% RH

Exp. Date 07-2017


implementation 01-07-2015 (API) Lot No YF20150401

Stability No. Doc. No.: GP / QC / SSP / 001

Sample taken for Physical tests = (6+6) = 12 Tablets


Sample taken for Microbiological tests =N.A

Extra Samples if needed = 5

Total sample size (approx) = 37 Tablets per test

Minutes for 253rd


Accelerated Stability Study Data Sheet

Assessment frequency (weeks) Initial After 01 month After 02

months After 03 months After 06 months

Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-16

Mode of testing (F= full, P= partial) F P F P F P F P F P

Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Conditions

(Accelerated)

Description

Oblong

shape white

color tablets

40◦C ±2◦C,

75%±5%

Complies Complies Complies Continue

Identification Positive for

Sofosbuvir

40◦C ±2◦C,

75%±5%

Positive Positive Positive Continue

Disintegration NMT 30

min

40◦C ±2◦C,

75%±5%

12 min 12.5 min 12.6 min Continue

Dissolution

NLT 85 %

in 30

minutes

40◦C ±2◦C,

75%±5%

98.16 % 97.78% 97.46% Continue

Assay

NLT 90.0%

and NMT

110.0%

40◦C ±2◦C,

75%±5%

101.15% 100.20 % 99.97 % Continue

Analyst Signature (after completion of every time

line)

Conclusion by QA (after completion of the study)

Minutes for 253rd


Real Time Stability Study Data Sheet

Assessment frequency (weeks) Initial After 03 months After 06 months After 09 months

Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16

Mode of testing (F= full, P= partial) F P F P F P F P

Tests (Physical,

Chemical,

Microbiological)

Acceptance Criteria

Storage

Conditions

(Accelerated)

Description Oblong shape white

color tablets

30◦C ±2◦C,

65%±5%

Complies Continue


Sofosbuvir

30◦C ±2◦C,

65%±5%

Positive Continue

Disintegration NMT 30 min

30◦C ±2◦C,

65%±5%

12.5 min Continue

Dissolution NLT 85 % in 30

minutes

30◦C ±2◦C,

65%±5%

98.16 % Continue

Assay NLT 90.0% and

NMT 110.0%

30◦C ±2◦C,

65%±5%

101.05 % Continue

Analyst Signature (after completion of every time line)


Minutes for 253rd



Post Expiry 01 Year Stability Study

Assessment frequency (weeks) After 12 months After 18 months After 24

months

After 30

months

After 36 months

Date of Testing 01-07-16 01-01-17 01-07-

17


Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Conditions

(Accelerated)

Description

30◦C ±2◦C,

65%±5%

Identification

30◦C ±2◦C,

65%±5%

Uniformity of dosage units

30◦C ±2◦C,

65%±5%

Disintegration

30◦C ±2◦C,

65%±5%

Dissolution

30◦C ±2◦C,

65%±5%

Assay

30◦C ±2◦C,

65%±5%



Minutes for 253rd


Product Details



Description of pack




Recommended storage

conditions


◦C, 75%±5% RH


◦C, 65%±5% RH

Exp. Date 07-2017




Sample taken for Physical tests = (6+6) = 12

Sample taken for Chemical tests = 20

Sample taken for Microbiological tests = N.A


Total sample size (Approx) = 37 Tablets Per Test

Minutes for 253rd



Assessment frequency (weeks) Initial After 01 month After 02 months After 03 months After 06 months

Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-

16


Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Conditions

(Accelerated)

Description

Oblong

shape white

color tablets

40◦C ±2◦C,

75%±5%



Sofosbuvir

40◦C ±2◦C,

75%±5%



min

40◦C ±2◦C,

75%±5%

12.1 min 12.5 min 12.6 min Continue

Dissolution

NLT 85 %

in 30

minutes

40◦C ±2◦C,

75%±5%

97.13% 97.78% 97.46% Continue

Assay

NLT 90.0%

and NMT

110.0%

40◦C ±2◦C,

75%±5%

101.22% 100.20 % 100.97 % Continue


line)


Minutes for 253rd




Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16


Tests (Physical,

Chemical,

Microbiological)

Acceptance Criteria

Storage

Conditions

(Accelerated)


color tablets

30◦C ±2◦C,

65%±5%

Complies Continue


Sofosbuvir

30◦C ±2◦C,

65%±5%

Positive Continue


30◦C ±2◦C,

65%±5%

12.5 min Continue


minutes

30◦C ±2◦C,

65%±5%

97.13 % Continue

Assay NLT 90.0% and

NMT 110.0%

30◦C ±2◦C,

65%±5%

101.05 % Continue



Minutes for 253rd




Assessment frequency (weeks) After 12 months After 18 months After 24 months After 30 months After 36 months

Date of Testing 01-07-16 01-01-17 01-07-17


Tests (Physical,

Chemical,

Microbiological)

Acceptance Criteria Storage

Conditions

(Accelerated)

Description

30◦C ±2◦C,

65%±5%

Identification

30◦C ±2◦C,

65%±5%

Uniformity of

dosage units

30◦C ±2◦C,

65%±5%

Disintegration

30◦C ±2◦C,

65%±5%

Dissolution

30◦C ±2◦C,

65%±5%

Assay

30◦C ±2◦C,

65%±5%



Minutes for 253rd


Product Details



Description of pack




Recommended storage

conditions


◦C, 75%±5% RH


◦C, 65%±5% RH

Exp. Date 07-2017




Sample taken for Physical tests = (6+6) = 12

Sample taken for Chemical tests = 20

Sample taken for Microbiological tests = N.A


Total sample size (Approx) = 37 Tablets per test

Minutes for 253rd




Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-

16


Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Conditions

(Accelerated)

Description

Oblong

shape white

color tablets

40◦C ±2◦C,

75%±5%



Sofosbuvir

40◦C ±2◦C,

75%±5%



min

40◦C ±2◦C,

75%±5%

12.4 min 11.9 min 12.4 min Continue

Dissolution

NLT 85 %

in 30

minutes

40◦C ±2◦C,

75%±5%

96.06 % 94.78 % 94.89 % Continue

Assay

NLT 90.0%

and NMT

110.0%

40◦C ±2◦C,

75%±5%

100.56 % 100.20 % 100.04 % Continue


line)


Minutes for 253rd




Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16


Tests (Physical,

Chemical,

Microbiological)

Acceptance Criteria

Storage

Conditions

(Accelerated)


color tablets

30◦C ±2◦C,

65%±5%

Complies Continue


Sofosbuvir

30◦C ±2◦C,

65%±5%

Positive Continue


30◦C ±2◦C,

65%±5%

12.7 min Continue


minutes

30◦C ±2◦C,

65%±5%

96.06 % Continue

Assay NLT 90.0% and

NMT 110.0%

30◦C ±2◦C,

65%±5%

100.56 % Continue



Continued…

Minutes for 253rd





Date of Testing 01-07-16 01-01-17 01-07-17


Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Conditions

(Accelerated)

Description

30◦C ±2◦C,

65%±5%

Identification

30◦C ±2◦C,

65%±5%

Uniformity of

dosage units

30◦C ±2◦C,

65%±5%

Disintegration

30◦C ±2◦C,

65%±5%

Dissolution

30◦C ±2◦C,

65%±5%

Assay

30◦C ±2◦C,

65%±5%


line)


Minutes for 253rd




Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-16


Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage Conditions

(Accelerated)

Description

Oblong shape

white color

tablets

40◦C ±2◦C,

75%±5%



Sofosbuvir

40◦C ±2◦C,

75%±5%



40◦C ±2◦C,

75%±5%

12 min 12.5 min 12.6 min Continue

Dissolution NLT 85 % in

30 minutes

40◦C ±2◦C,

75%±5%

98.16 % 97.78% 97.46% Continue

Assay

NLT 90.0%

and NMT

110.0%

40◦C ±2◦C,

75%±5%

101.15% 100.20 % 99.97 % Continue



Minutes for 253rd




Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16


Tests (Physical,

Chemical,

Microbiological)

Acceptance Criteria

Storage

Conditions

(Accelerated)


color tablets

30◦C ±2◦C,

65%±5%

Complies Continue


Sofosbuvir

30◦C ±2◦C,

65%±5%

Positive Continue


30◦C ±2◦C,

65%±5%

12.5 min Continue


minutes

30◦C ±2◦C,

65%±5%

98.16 % Continue

Assay NLT 90.0% and

NMT 110.0%

30◦C ±2◦C,

65%±5%

101.05 % Continue



Minutes for 253rd





Date of Testing 01-07-16 01-01-17 01-07-17


Tests (Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Conditions

(Accelerated)

Description

30◦C ±2◦C,

65%±5%

Identification

30◦C ±2◦C,

65%±5%

Uniformity of dosage

units

30◦C ±2◦C,

65%±5%

Disintegration

30◦C ±2◦C,

65%±5%

Dissolution

30◦C ±2◦C,

65%±5%

Assay 30◦C ±2◦C,

65%±5%


line)


Minutes for 253rd



M/s Glitz, Islamabad


1. COA of API Yes



origin.

No




No

5. Documents confirming import of API etc. No



Yes


product.

No

Decision: Mr. Kiramatullah, Quality Control manager presented the data. The Board observed that the stability data provided by the firm

is not in accordance with the guidelines approved by the Board in 251st meeting as firm has not provided approval of API by regulatory

authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin, data of 03

batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets and commitment to

continue real time stability study till assigned shelf life of the product. Therefore, case was deferred till the applicant completes the requisite

information in respect of stability studies.

Minutes for 253rd


14. M/s Shrooq Pharma, Lahore

Drug Sofvir tablets (Sofosbuvir) 400 mg

Source Virupaksha Organics Ltd. India



Frequency 0, 1,2, 3, 4,5, 6 months

Batch Size 400/ batch

No. of Batches 03



st meeting of Registration

Board

Attributes Tested (Batch 1)


Sr.

No.

Attribute Specifications Results

(Initial)

Results

(1

months)

Results

(2

months)

Results

(3

months)

Results

(4

months)

Results

(6

months)

1. Appearance White

colored

oblong

shaped film

coated tablets

Complied Complied Complied Complied Complied Complied

2. Identification +ve +ve +ve +ve +ve +ve +ve

3. Disintegration

time (mins)

NMT 30 mins 6 6 6 7 6 6

4. Average Wt 685 mg ± Complied Complied Complied Complied Complied Complied

Minutes for 253rd


5.0%

5. Assay % 90-110% 99% 99% 99% 99% 99% 99%

Attributes Tested (Batch 2) Accelerated: 40 C and 75% RH

Sr.

No.


(Initial)

Results

(1

months)

Results

(2

months)

Results

(3

months)

Results

(4

months)

Results

(6

months)

1. Appearance White

colored

oblong

shaped film

coated tablets



3. Disintegration

time (mins)

NMT 30 mins 6 6 6 7 6 6

4. Average Wt 685 mg ±

5.0%


5. Assay % 90-110% 99% 99% 99% 99% 99% 99%

Attributes Tested (Batch 3) Accelerated: 40 C and 75% RH

Sr.

No.


(Initial)

Results

(1

months)

Results

(2

months)

Results

(3

months)

Results

(4

months)

Results

(6

months)

1. Appearance White

colored

oblong

shaped film

coated tablets



3. Disintegration

time (mins)

NMT 30 mins 6 6 6 7 6 6

4. Average Wt 685 mg ± Complied Complied Complied Complied Complied Complied

Minutes for 253rd


5.0%

5. Assay % 90-110% 99% 99% 99% 99% 99% 99%

Documents / Data provided by the applicant (M/s Shrooq Pharma, Lahore)


1. COA of API Yes



origin.

No




Data of only accelerated

stability studies provided




Yes


product.

Yes

Decision: Mr. Gulsher Zaidi, Import Manager presented the data before Registration Board. The Board observed that the stability data

provided by the firm is not in accordance with the guidelines approved by the Board in 251st meeting as firm has not provided approval of

API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin

and real time stability data of 03 batches along with attested respective documents like chromatograms, laboratory reports, data sheets.

Therefore, case was deferred till the applicant completes the requisite information in respect of stability studies.

Minutes for 253rd


15. M/s Macter International Karachi

Drug Sofomac tablets (Sofosbuvir) 400 mg

Source Xiamen halosyntech Limited China


Real Time: 30°C ± 2°C/65% ± 5% RH)


Frequency 0,1,3,6 months

Batch Size Batch I: 350 Tablets

Batch II: 350Tablets

Batch III: 2125 tabs

No. of Batches 03

Sample Size 196



Registration Board

Product: Sofomac 400mg Tablets Storage Condition: 30˚C + 2˚C & 65% + 5% RH

Batch / Lot # S001 Mfg. Date: Feb-14

Pack Size: 14's & 28's Expiry Date: Feb-16

Packaging Material: Bottle, Cap, Label, Unit carton &

Leaflet Storage period: Initial, 3 & 6 months

Test for Finished product Specifications Initial 3 Months 6 Months

Minutes for 253rd


Physical Appearance Elongated film coated tablet complies complies complies

Disintegration time NMT 30 minutes 8 min 8 min 9 min

Dissolution NLT 75% 92.32% 91.65% 90.78%

Assay Sofosbuvir

90- 110% 102.11% 101.68% 100.94%

Batch 2









Dissolution NLT 75% 93.11% 92.63% 91.82%

Assay Sofosbuvir

90- 110% 102.81% 102.35% 101.66%

Minutes for 253rd


Batch 3









Dissolution NLT 75% 92.64% 91.82% 90.94%

Assay Sofosbuvir

90- 110% 103.34% 102.75% 101.88%




Minutes for 253rd



Leaflet Storage

period: Initial, 3 & 6 months




Dissolution NLT 75% 92.32% 91.45% 90.67%

Assay Sofosbuvir

90- 110% 102.11% 101.53% 100.75%

Batch 2





Leaflet Storage




Minutes for 253rd



Dissolution NLT 75% 93.11% 92.32% 91.41%

Assay Sofosbuvir

90- 110% 102.81% 102.21% 101.34%

Batch 3





Leaflet Storage





Dissolution NLT 75% 92.64% 91.71% 90.74%

Assay Sofosbuvir

90- 110% 103.34% 102.55% 101.61%

Minutes for 253rd



(M/s Macter Pharma, Karachi)


1. COA of API Yes



origin.

No




No (Chromatograms and

related data not provided)




Yes


product.

Yes

Decision: Dr.Salman Zaidi, Director Technical appeared befor Registration Board and clarified that M/s Ximen Halosyntech China

is located in Benbhu, China and Benbhu Tushan Pharmaceutical China is GMP owner and contract manufacturing for plant for

Xiamen. He aprovided COA and GMP certificate for manufacturer of the API i.e. Benbhu Tushan Pharmaceutical China. He also

provided raw data and documents confirming import of API by courier. Keeping in view data submitted, Registration Board granted




Minutes for 253rd


16. M/s Welmark Pharma, Hattar

Drug Sofomark (Sofosbuvir) 400mg

Source Jiangxi Synergy Pharmaceutical Co., Ltd. China

(For trial purpose)

Storage

Conditions

Real Time: 30oC + 2

oC and 65% + 5% RH

Accelerated: 40oC + 2

oC and 75% + 5%RH




0, 3, 6 months

Batch Size 50 tablets, 50 tablets

No. of Batches 02 (T1 and T2)

Sample Size 20 Tablets

Meeting Deferred in 244 and 251 meeting

Attributes Tested - Batch# T1

Product: Sofomark 400mg tablet Mfg. Date: 02 - 2015 Date of Commencement: 11-02-

2015

Product Code: N/A Exp. Date: 01 - 2017 Date of Completion: 11-08-2015

Batch#: T1 Shelf Life: 2 Years Pack Size: 7's

Packaging Material: HDPE Bottle

with cap, Silica dessicant, Leaflet,

Unit Carton

Storage Period: Initial, 1, 3 & 6 months

S.No Attribute Specifications Results

(Initial)

Results

(1 month)

Results

(3 months)

Results

(6 months)

1. Appearance White colored

oblong shaped

film coated

tablets

RT:

Complied

Acc:

Complied

RT:

Complied

Acc:

Complied

RT:

Complied

Acc:

Complied

RT:

Complied

Acc:

Complied

2. Identification Must be Positive Positive Positive Positive Positive

Minutes for 253rd


3. Dissolution NLT 85% RT: 99%

Acc: 97%

RT: 99%

Acc: 99%

RT: 99%

Acc: 99%

RT: 99%

Acc: 95%

4. Disintegration

time

NMT 30

minutes

RT: 7 min

Acc: 7 min

RT: 7 min

Acc: 7 min

RT: 7 min

Acc: 8 min

RT: 7 min

Acc: 9 min

5. Total

Degradation

Product

NMT 0.8% RT:

Complied

Acc:

Complied

RT:

Complied

Acc:

Complied

RT:

Complied

Acc:

Complied

RT:

Complied

Acc:

Complied

6. Assay% 90-110% RT: 103%

Acc: 103%

RT: 102%

Acc: 102%

RT: 102%

Acc: 101%

RT: 100%

Acc: 99%

Attributes Tested - Batch# T2

Product: Sofomark 400mg tablet Mfg. Date: 02 - 2015 Date of Commencement: 16-02-2015

Product Code: N/A Exp. Date: 01 - 2017 Date of Completion: 16-08-2015

Batch#: T2 Shelf Life: 2 Years Pack Size: 7's

Packaging Material: HDPE Bottle

with cap, Silica dessicant, Leaflet,

Unit Carton

Storage: Initial, 3 & 6 months

S.No. Attribute Specifications Results (Initial) Results

(3 months)

Results

(6 months)

1. Appearance White colored

oblong shaped

film coated

tablets

RT: Complied

Acc: Complied

RT: Complied

Acc: Complied

RT: Complied

Acc: Complied

2. Identification Must be Positive Positive Positive Positive

3. Dissolution NLT 85% RT: 99%

Acc: 97%

RT: 99%

Acc: 99%

RT: 99%

Acc: 94%

4. Disintegration

Time

NMT 30 minutes RT: 7 min

Acc: 7 min

RT: 7 min

Acc: 7 min

RT: 8 min

Acc: 10 min

5. Total NMT 0.8% RT: Complied RT: Complied RT: Complied

Minutes for 253rd


Degradation

Product

Acc: Complied Acc: Complied Acc: Complied

6. Assay% 90-110% RT: 103%

Acc: 103%

RT: 102%

Acc: 100%

RT: 102%

Acc: 98.8%


(M/s Welmark Pharma, Hattar)


1. COA of API Yes



origin.

No

3. Protocols followed for conduction of stability study and details of tests. No



No




Photocopies provided


product.

No

Decision: Mr. Muhammad Muneer, Quality Control Manager presented the data before Registration Board. The Board observed that the

stability data provided by the firm is not in accordance with the guidelines approved by the Board in 251st meeting as firm has not provided

approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of

country of origin, protocols followed for conduction of stability study and details of tests, data of 03 batches along with attested respective

documents like chromatograms, laboratory reports, data sheets and Commitment to continue real time stability study till assigned shelf life

of the product . Therefore, case was deferred till the applicant completes the requisite information in respect of stability studies.

Minutes for 253rd


17. M/ s Searle Company Ltd Karachi

Firm M/ s Searle Company Ltd Karachi

Drug Sobvi 400mg

Source Beijing Huikang Bouyan China

Storage Condition 40C, 75±5RH,

30C, 75±5RH

Time Period 0,3,6,9

Frequency 03 Months Interval

Batch Size

No. of Batches 03

Sample Size

Meeting M-244th

and 249th

Stability Data Report

Product Name: SOBVI 400mg TABLETS Ref. # 3651/A Packaging: Alu / Alu Blister

(Sofosbuvir)

B.No. 14 PD-080/A Mfg.Date: 10-2014

Shelf Life: 2Years Exp. Date: 10-2016

Test Specifications Initial 03 Month 06 Month 09 Month

Ambient Ambient Ambient

Description

Yellow colored, biconvex, oblong shaped,

film coated tablets, engraved breakline on

one side and plain on other side.


Assay

(Sofosbuvir)

400mg /tab

90% to 110% of L.C 101.72% 101.69% 101.92% 102.01%

Minutes for 253rd


Disintegration Time NMT 30 mins 2 mins 2 mins 4 mins 3 mins

Dissolution test NLT 80% released in 60 minutes 90.56% 90.73% 93.58% 102.31%

Ambient Condition: 30ºC + 2ºC / 65% RH + 5% RH

Product Name: SOBVI 400mg TABLETS Ref. # 3651/A Packaging: Alu / Alu Blister

(Sofosbuvir)

B.No. 14 PD-080/A Mfg.Date: 10-2014


Test Specifications Initial 03 Month 06 Months

Accelerated condition Accelerated condition

Description

Yellow colored, biconvex, oblong

shaped, film coated tablets,

engraved breakline on one side

and plain on other side.


Assay

(Sofosbuvir)

400mg /tab

90% to 110% of L.C 101.72% 101.70% 101.95%

Disintegration Time NMT 30 mins 2 mins 3 mins 3 mins

Dissolution test NLT 80% released in 60 minutes 90.56% 91.58% 95.88%

Minutes for 253rd


Accelerated Condition: 40ºC + 2ºC / 75% + 5% RH

Product Name: SOBVI 400mg TABLETS Ref. # 3651/B Packaging: Alu / Alu Blister

(Sofosbuvir)

B.No. 14 PD-080/B Mfg.Date: 10-2014




Description





Assay

(Sofosbuvir)

400mg /tab

90% to 110% of L.C 101.85% 101.37% 101.25% 100.88%




Product Name: SOBVI 400mg TABLETS Ref. # 3651/B Packaging: Alu / Alu Blister

(Sofosbuvir)

B.No. 14 PD-080/B Mfg.Date: 10-2014




Minutes for 253rd


Description


shaped, film coated tablets, engraved

breakline on one side and plain on other

side.


Assay

(Sofosbuvir)

400mg /tab

90% to 110% of L.C 101.85% 101.72% 101.36%




Product Name: SOBVI 400mg TABLETS Ref. # 3651/C Packaging: Alu / Alu Blister

(Sofosbuvir)

B.No. 14 PD-080/C Mfg.Date: 10-2014




Description





Assay

(Sofosbuvir)

400mg /tab

90% to 110% of L.C 101.68% 101.56% 101.36% 99.33%


Minutes for 253rd




Product Name: SOBVI 400mg TABLETS Ref. # 3651/C Packaging: Alu / Alu Blister

(Sofosbuvir)

B.No. 14 PD-080/C Mfg.Date: 10-2014




Description


shaped, film coated tablets, engraved

breakline on one side and plain on

other side.


Assay

(Sofosbuvir)

400mg /tab

90% to 110% of L.C 101.68% 101.34% 100.58%





(M/s Searl Pharma, Karachi)


Minutes for 253rd


1. COA of API Yes



origin.

Yes




Yes

5. Documents confirming import of API etc. Yes (by courier)

200gms



Yes


product.

Yes

Decision: Mr.Anwar Jamal presented the data. Registration Board observed that the stability data provided by the firm is in

accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of

Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample

of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs


Minutes for 253rd


18. M/s Wilson Pharmaceuticals Islamabad

Drug Saferon Tablets 400mg

Source Virupaksha organics Limited, India




Frequency 0,3,6 months

Batch Size 500 tablets

No. of Batches 3

Sample Size 424 x 3

Meeting 244& 251

ACCELERATED STABILITY STUDY

Product Name: Saferon Tablets Batch #: 01

Composition:Each Tablet Contains Batch Size: 500 tablets

Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016

Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6 months

Type of Container / Packaging: Alu-Alu/Alu-PVC Strip

Minutes for 253rd


Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.




Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016



Test

Performed

Internal /Standard

Specification

RESULTS

Initial at the time of

Mfg.(Zero)

After

03 months

After

06 months

Physical

Appearance Film coated tablets Complies Complies Complies

Identification

Sample profile


standard


Disintegration

Time NMT 30 minutes 7: 00 minutes 7:00 minutes 6:00 minutes

Dissolution

NLT 75% 95.59% 94.45% 93.57%

Assay

90-110% 105.72% 105.21% 105.11%

Minutes for 253rd






Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016

Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03months

After

06months

Physical


Identification

Sample profile


standard


Disintegration

Time NMT 30 minutes 8:00 minutes 7:02 minutes 6:02 minutes

Dissolution

NLT 75% 94.80% 94.35% 94.13%

Assay

90-110% 105.43% 105.14% 105.00%

Minutes for 253rd





Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06 months

Physical


Identification

Sample profile


standard


Disintegration


Dissolution

NLT 75% 95.54% 95.18% 95.02%

Assay

90-110% 105.99% 105.44% 105.27%

Minutes for 253rd


LONG TERM STABILITY STUDY



Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016

Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6,9 months


Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06months

After

09 months

Physical

Appearance Film coated tablets Complies Complies Complies Complies

Identification

Sample profile


standard


Disintegration

Time NMT 30 minutes 7:00 minutes 6:02 minutes 7:02 minutes 7:01 minutes

Dissolution

NLT 75% 95.59% 95.18% 93.95% 93.43%

Assay

90-110% 105.72% 105.41% 105.06% 104.33%

Minutes for 253rd


Remarks: After the period of 9 months long term stability study, no change in physical & chemical characters observed.




Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016



Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06months

After

09 months

Physical


Identification

Sample profile


standard


Disintegration


Dissolution

NLT 75% 94.80% 94.51% 94.12% 93.75%

Minutes for 253rd






Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016



Assay

90-110% 105.43% 105.20% 105.00% 104.25%

Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06months

After

09 months

Physical


Identification

Sample profile


standard


Minutes for 253rd



Documents / Data provided by the applicant (M/s Wilson Pharma, Islamabad)


1. COA of API Yes



origin.

Yes




Yes

5. Documents confirming import of API etc. Yes (Courier)



Yes


product.

Yes

Decision: Mr.Tipu Sultan Akram presented the data. Registration Board observed that the stability data provided by the firm is in





Disintegration

Time NMT 30 minutes 6:00 minutes 6:02minutes 7:02 minutes 7:00 minutes

Dissolution

NLT 75% 95.54% 95.30% 95.05% 94.66%

Assay

90-110% 105.99% 105.55% 105.13% 104.19%

Minutes for 253rd


19. M/s Werrick Pharmaceuticals Islamabad

Drug Cell-tab Tablets 400mg







No. of Batches 3

Sample Size 424 x 3

Meeting 244& 251


Product Name: Cell-Tab Tablets Batch #: 01


Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016



Test

Performed

Internal /Standard

Specification

RESULTS

Minutes for 253rd






Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016




Mfg.(Zero) After

03months

After

06 months

Physical


Identification

Sample profile


standard


Disintegration


Dissolution

NLT 75% 93.59% 92.45% 90.57%

Assay

90-110%

105.72%

105.21% 105.11%

Minutes for 253rd






Sofosbuvir----400mg

Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06 months

Physical


Identification

Sample profile


standard


Disintegration

Time NMT 30 minutes 8:00 minutes 7:01 minutes 8 :01minutes

Dissolution

NLT 75% 94.66% 94.35% 94.19%

Assay

90-110%

105.50%

105.27% 105.13%

Minutes for 253rd


Mfg. Date: 12-2014 Exp. Date: 12-2016




Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06 months

Physical


Identification

Sample profile


standard


Disintegration


Dissolution

NLT 75% 93.88% 93.59% 93.11%

Assay

90-110%

105.95%

105.50% 105.25%

Minutes for 253rd





Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016



Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06 months

After

09 months

Physical


Identification

Sample profile


standard


Disintegration

Time NMT 30 minutes 7:00minutes 6:00 minutes 7:00minutes 7:01minutes

Dissolution

NLT 75% 93.59% 92.19% 91.00% 91.80%

Assay

90-110% 105.72% 105.30% 105.15% 104.95%

Minutes for 253rd


Remarks:After the period of 9 months long term stability study, no change in physical & chemical characters observed.




Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016



Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06months

After

09 months

Physical


Identification

Sample profile


standard


Disintegration

Time NMT 30 minutes 8:00minutes 6:01 minutes 7:01 minutes 7:00 minutes

Dissolution

NLT 75% 94.66% 94.41% 94.00% 93.52%

Minutes for 253rd






Sofosbuvir----400mg

Mfg. Date: 12-2014 Exp. Date: 12-2016



Assay

90-110% 105.50% 105.28% 105.01% 104.34%

Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06 months

After

09 months

Physical


Identification

Sample profile


standard


Disintegration

Time NMT 30 minutes 7:00 minutes 6:01minutes 7:02minutes 7:02minutes

Minutes for 253rd



Documents / Data provided by the applicant (M/s Werrick Pharma, Islamabad)


1. COA of API Yes



origin.

Yes




Yes




Yes


product.

Yes


accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir

400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active

Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi

before sale of finished product.

Dissolution

NLT 75% 93.88% 93.35% 93.10% 92.88%

Assay

90-110% 105.95% 105.49% 105.23% 105.00%

Minutes for 253rd


20. M/s Scottmann Pharmaceuticals Islamabad

Drug HEPALDI Tablets 400mg







No. of Batches 3

Sample Size 424 x 3

Meeting 252


Product Name: Hepaldi Tablets Batch #: 01

Composition: Each Tablet Contains Batch Size: 500 tablets

Sofosbuvir----400mg

Mfg. Date: 11-2014 Exp. Date: 11-2016

Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6, 9 months


Minutes for 253rd



ACCELERATED STABILITY STUDY Product Name: Hepaldi Tablets Batch #: 01


Sofosbuvir----400mg

Mfg. Date: 11-2014 Exp. Date: 11-2016

Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6months


Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06 months

After

09 months

Physical


Identification

Sample profile


standard


Disintegration


Dissolution

NLT 75% 93.59% 93.37% 92.95% 92.54%

Assay

90-110% 104.74% 104.45% 104.20 104.00%

Minutes for 253rd



Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06months

Physical


Identification

Sample profile


standard


Disintegration


Dissolution

NLT 75% 93.59% 93.11% 92.40%

Assay

90-110% 104.74% 104.54% 104.30%

Minutes for 253rd





Sofosbuvir----400mg

Mfg. Date: 11-2014 Exp. Date: 11-2016



Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06 months

After

09 months

Physical


Identification

Sample profile


standard


Disintegration

Time NMT 30 minutes 7:00 minutes 6:01 minutes 7:01minutes 8:01minutes

Dissolution

NLT 75% 94.46% 94.13% 93.85% 93.27%

Assay

90-110% 104.88% 104.66% 104.42% 104.22%

Minutes for 253rd






Sofosbuvir----400mg

Mfg. Date: 11-2014 Exp. Date: 11-2016



Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06months

Physical


Identification

Sample profile


standard


Disintegration


Minutes for 253rd






Sofosbuvir----400mg

Mfg. Date: 11-2014 Exp. Date: 11-2016

Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6, 9 months


Dissolution

NLT 75% 94.46% 94.05% 93.75%

Assay

90-110% 104.88% 104.49% 104.30%

Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06 months

After

09months

Physical


Minutes for 253rd




(ICH GUIDELINE)



Sofosbuvir----400mg

Mfg. Date: 11-2014 Exp. Date: 11-2016



Identification

Sample profile


standard


Disintegration


Dissolution

NLT 75% 95.55% 95.12% 94.87% 94.29%

Assay

90-110% 104.68% 104.45% 104.21% 104.09%

Minutes for 253rd




(M/s Scottman Pharma, Islamabad)


1. COA of API Yes



origin.

Yes

Test

Performed

Internal /Standard

Specification

RESULTS


Mfg.(Zero) After

03 months

After

06months

Physical


Identification

Sample profile


standard


Disintegration


Dissolution

NLT 75% 95.55% 95.41% 95.25%

Assay

90-110% 104.68% 104.41% 104.25%

Minutes for 253rd





Yes




Yes


product.

Yes






Minutes for 253rd


21. M/s Max Pharmaceuticals Islamabad

Drug Sofavir tablets (Sofosbuvir) 400 mg

Source Changzou Pharmaceutical Factory Co. Ltd

China


Real Time: 30°C ± 2°C/65% ± 5% RH)




Batch II: 1000 Tablets

Batch III: 900 tabs

No. of Batches 03

Sample Size 10 packs



Registration Board

Stability study Report

Product Name/ Generic

Name/ Dosage Form

Sofavir (Sofosbuvir) 400mg

Tablet Batch No. 15T01

Description of pack

Oblong shaped film coated

tablets filled in pet bottle &

packed in carton Batch Size 500 Tablets

Parameter and test

mentioned As per Product specification

Manufacturing

Date 01-2015

Recommended storage

conditions

Short term condition (Accelerated) 40°C ± 2, RH 75 % ± 5

Long term condition (Real Time) 30°C ± 2, RH 65 % ± 5 Expiry Date 01-2017

Minutes for 253rd



Date of Testing 23/01/2015 23/04/2015 23/07/2015

Mode of testing (F = Full, P = Partial testing)F P F P F F F F F F F F

Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Condition

(Accelerated)

Appearance 19mm oblong,

Off White Coated

Tablets

400C+-20C

75% RH +-5%RH Complies Complies Complies

Identification Sofosbuvir must

be Positive

400C+-20C

75% RH +-5%RH Positive Positive Positive

Disintegration time NMT 30minuts 400C+-20C

75% RH +-5%RH 13 Minutes 14 Minutes 14Minutes

Dissolution NLT 75% 400C+-20C

75% RH +-5%RH 94% 92% 89%

Assay 90-110% 400C+-20C

75% RH +-5%RH 100.4% 99.5% 98.7%



implementation 13-01-2015 API lot NO. 150503

Stability No. 15SOFO-STB-01 Date of

Storage 20-01-2015

Sample taken for Physical testing =04

Sample taken for Chemical testing =04

Sample taken for Microbial testing =NA

Sample taken Extra =02

Total sample size = 10packs

Minutes for 253rd


Conclusion by QC (After completion of the study):

Above data shows that the results of all the physical and chemical parameters are within limits during 6 months accelerated stability studies. So

the product is stable.


Date of Testing 23/01/2015 23/04/2015 23/07/2015


Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Condition

(Real Time)


Off White Coated

Tablets

300C+-20C

65% RH +-

5%RH Complies Complies Complies


be Positive

300C+-20C

65% RH +-

5%RH Positive Positive Positive

Disintegration time NMT 30minuts

300C+-20C

65% RH +-

5%RH 13 Minutes 13 Minutes 14Minutes


65% RH +-

5%RH

94% 94% 93%

Assay 90-110%

300C+-20C

65% RH +-

5%RH

100.4% 100% 99.8%





Minutes for 253rd








Date of Testing 23/01/2015 23/04/2015 23/07/2015


Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Condition

(Accelerated)

Product Name/ Generic Name/

Dosage Form Sofavir (Sofosbuvir) 400mg Tablet Batch No. 15T02

Description of pack Oblong shaped film coated tablets filled in pet bottle &


Parameter and test mentioned As per Product specification Manufacturing Date 01-2015



Long term condition (Real Time) 30°C ± 2, RH 65 % ± 5

Expiry Date 01-2017



Stability No. 15SOFO-STB-02 Date of Storage 25-01-2015

Minutes for 253rd



Off White Coated

Tablets

400C+-20C



be Positive

400C+-20C





75% RH +-5%RH 92% 91% 88%

Assay 90-110% 400C+-20C

75% RH +-5%RH 101% 100.2% 99.8%






Date of Testing 23/01/2015 23/04/2015 23/07/2015


Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Condition

(Real Time)


Off White Coated

Tablets

300C+-20C

65% RH +-



be Positive

300C+-20C

65% RH +-



65% RH +-14 Minutes 13 Minutes 13Minutes

Minutes for 253rd


5%RH


65% RH +-

5%RH

92% 92% 91%

Assay 90-110%

300C+-20C

65% RH +-

5%RH

101% 99.8% 100%







Product Name/ Generic Name/

Dosage Form Sofavir (Sofosbuvir) 400mg Tablet Batch No. 15T03

Description of pack Oblong shaped film coated tablets filled in pet bottle &


Parameter and test mentioned As per Product specification Manufacturing

Date 01-2015

Recommended storage

conditions


Long term condition (Real Time) 30°C ± 2, RH 65 % ± 5

Expiry Date 01-2017



Stability No. 15SOFO-STB-03 Date of Storage 25-01-2015

Minutes for 253rd






Date of Testing 23/01/2015 23/04/2015 23/07/2015


Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Condition

(Accelerated)


Off White Coated

Tablets

400C+-20C



be Positive

400C+-20C





75% RH +-5%RH 95% 93% 90%

Assay 90-110% 400C+-20C

75% RH +-5%RH 100.5% 99.3% 98.6%





Minutes for 253rd



Date of Testing 23/01/2015 23/04/2015 23/07/2015


Tests(Physical,

Chemical,

Microbiological)

Acceptance

Criteria

Storage

Condition

(Real Time)


Off White Coated

Tablets

300C+-20C

65% RH +-



be Positive

300C+-20C

65% RH +-


Disintegration time NMT 30minuts

300C+-20C

65% RH +-

5%RH 13 Minutes 13 Minutes 12Minutes


65% RH +-

5%RH

95% 94% 94%

Assay 90-110%

300C+-20C

65% RH +-

5%RH

100.5% 99.6% 100%





Minutes for 253rd


Documents / Data provided by the applicant (M/s Max Pharmaceuticals Islamabad)


1. COA of API Yes

2. Approval of API by regulatory authority of country of

origin or GMP certificate of API manufacturer issued by

regulatory authority of country of origin.

Yes

3. Protocols followed for conduction of stability study and

details of tests.

Yes


respective documents like chromatograms, laboratory

reports, data sheets etc.

Yes

5. Documents confirming import of API etc.

Yes (by courier)

6. All provided documents will be attested (name, sign and

stamp) for ensuring authenticity of data / documents.

Yes



Yes

Decision: Mr.Riaz, Quality Control Manager presented the data. Registration Board observed that the stability data provided by the

firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration

of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking

sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs


Minutes for 253rd


22. M/s Biogen Pharma Islamabad

Drug Sofbugen tablets (Sofosbuvir) 400 mg

Source Not submitted


Real Time: 30°C ± 2°C/65% ± 5% RH)

Time Period 5 months accelerated

6months real time

Frequency 0, 1,2 3, 4,5,6 months (Accelerated)

0,3,6 (Real Time)

Batch Size Batch I: 1000 Packs

Batch II: 1000 Packs

Batch III: 1000 Packs

No. of Batches 03

Sample Size Nil



Registration Board

Minutes for 253rd



(M/s Biogen Pharma Islamabad)


1. COA of API No




No


details of tests.

No




No




No



No

Decision: Mr.Khalid Qayyum, Quality Control Manager appeared for presentation of data. Registration Board observed that the stability

data provided by the firm was not in accordance with the guidelines approved by the board finalized in 251st meeting. Therefore, case was

deferred till the applicant completes the requisite information in respect of stability studies.

Minutes for 253rd


22. M/s Valor Pharma Islamabad

Drug HEPAVIR tablets (Sofosbuvir) 400 mg

Source Not submitted


Time Period 5 months accelerated

6months real time

Frequency 0,2 ,4 ,6 months (Accelerated)

Batch Size Nil

No. of Batches 01

Sample Size Nil



Registration Board


(M/s Valor Pharma Islamabad)


1. COA of API No




No


details of tests.

No

4. Data of 03 batches will be supported by attested No

Minutes for 253rd







No



No

Decision: Mr. Asif Iqbal, Quality Control Manage appeared for presentation of data. Registration Board observed that the stability data

provided by the firm was not in accordance with the guidelines approved by the board finalized in 251st meeting. Therefore, case was

deferred till the applicant completes the requisite information in respect of stability studies.

Minutes for 253rd


23. M/s Everest Pharmaceuticals Islamabad

Drug Ledisovir tablets (Ledipasvir 90 mg +

Sofosbuvir) 400 mg

Source Ruyuan HEC Pharm Co. China


Real Time: 30°C ± 2°C/65% ± 5% RH)

30°C ± 2°C/75% ± 5% RH


Frequency 0, 1,2 3,4, 6, 8,12,16,20,24,26 weeks

0,3,6 months




No. of Batches 03


Meeting Deferred in 251st meeting of Registration

Board

Remarks Latest GMP inspection report is not provided,

However the firm has submitted that they have

requested FID Islamabad four times dated 21-

03-15, 26-03-15, 14-04-15 & 27-04-15 for

conduction of GMP inspection and for this

purpose they have submitted 5000/- as per

DRAP requirement.

Minutes for 253rd



Product name /Generic name/Dosage

form

LEDISOVIR 90mg /400 mg Tablets /Ledipasvir+Sofosbuvir/Tablets Batch No. X.01.01/15

Description of pack

( container closure system)

13mm Round white film coated tablets, plain ,blistered in 260mm aluminum foil in a 14x 2 printed unit

carton, 200u/c further packed in master shipper. Batch

Size.

500 Tablets

Parameters and test mentioned As product Specifications provided Mfg. Date 01/15

Recommended storage condition

Short term conditions (Accelerated ) 40± 2C, 75±5 RH

(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,

Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26

Long term conditions (Real Time) 30± 2C, 65±5 RH



In addition (already completed and submitted to DRAP)

Stability Study

(Proposed)

Storage

Conditions

Study

Duration

Study

Name

(Long Term)

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S1

S2

S3

S4

(Accelerated/Open Dish) 25 ⁰C /60% RH

30 ⁰C /75% RH

45 days

45 days

S5

S6

(Accelerated/Stress)

50 ⁰C /Ambient 25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S7

S8

S9

Stability Study (Proposed) Storage

Conditions

Study

Duration

Study Name

Short term conditions (Accelerated ) 40± 2C, 75±5

RH

0 months

3 months

0 months

3 months

Exp Date

01/17 (as

per

calculation

of

Accelerated

Stability

Study)

Minutes for 253rd


6 mon hs 6 months

Long t rm conditions (Real Time) 30± 2C, 65±5 RH

0 months

3 months

6 months

0 months

3 months

6 months

Respective documents, Assay Reports document No.(EP/QC/QR/010),Analytical Report Products document No.

(EP/QC/QR/008), Stability summary document No. (EV-QR-DRAP-ST-030), Photometric Report Instrument

generated, Spectrum of Standard solution Instrument generated, Spectrum of Sample solution Instrument generated,

Stability study Data document No.(EP/QC/QR/033),Chromatogram of Standard Solution and Sample Solution , duly

sign and stamp are attached.

Date of

initiation &

implementation

Storage

Conditions

Study

Duration

Study Name Date of

Initiation

Date of Completion

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S-1

S-2

S-3

S-4

07-01-2015

08-01-2015

09-01-2015

10-01-2015

07-01-2017 (study of 06 Months 07-07-2015 completed) continue….


09-01-2017(study of 06 Months 09-07-2015 completed) continue….

10-07-2015 (study of 06 Months completed)

25 ⁰C /60% RH

30 ⁰C /75% RH

45 days

45 days

S-5

S-6

12-01-2015

13-01-2015

26-02-2015 (study of 45 days completed)


50 ⁰C /Ambient

25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S-7

S-8

S-9

14-01-2015

15-01-2015

16-01-2015




Initial (0 Time)

Initial (0 Time)

(API)lot

no.

A15070018-01

Minutes for 253rd


40± 2C, 75±5 RH

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

07-01-2015

08-07-2015 (study of 26 weeks completed)

30± 2C, 65±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

07-01-2015 08-07-2015 (study of 26 weeks completed)

40± 2C, 75±5 RH

0 months

3 months

6 months

0 months

3 months

6 months 07-01-2015 07-07-2015 (study of 06 Month completed)

30± 2C, 65±5 RH

0 months

3 months

6 months

0 months

3 months


Minutes for 253rd


Approval by:

QC Manager: ---------------------

QA Manager: ---------------------

Product Manager: ---------------

R&D Manager: -------------------

Stability No. Following 13 Stability studies of SOVIR 400mg Tablets Batch No. X.01.01/15 are conducted, out of which only

3 studies S-1,S-2,S-3 are continue and will be completed on 06-08-2016 remaining all are completed. Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 26 weeks

Long term conditions (Real Time) at 30± 2C, 65±5 RH of 26 weeks

Long term conditions (Real Time) at 25 ⁰C /60% RH of 24 Months




(Accelerated/Open Dish) 25 ⁰C /60% RH of 45 Days

(Accelerated/Open Dish) at 30 ⁰C /75% RH of 45 Days

(Accelerated/Stress) at 50 ⁰C /Ambient of 45 Days

(Accelerated/Stress) at 25 ⁰C /80% RH of 45 Days

(Accelerated/Stress) at 5 ⁰C of 45 Days

Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 06 Months

Long term conditions (Real Time) at 30± 2C, 65±5 RH of 06 Months


Sample taken for chemical test = 195 Tablets

Extra sample = 11 Tablets

Total Sample size (approx ) = 491 Tablets

Minutes for 253rd




form

LEDISOVIR 90mg /400 mg Tablets /Ledipasvir+Sofosbuvir/Tablets Batch No. P.01.01/15

Description of pack




Size.

2000

Tablets










Stability Study

(Proposed)

Storage

Conditions

Study

Duration

Study

Name

(Long Term)

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S1

S2

S3

S4


30 ⁰C /75% RH

45 days

45 days

S5

S6


50 ⁰C /Ambient 25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S7

S8

S9


Conditions

Study

Duration

Study Name


RH

0 months

3 months

6 months

0 months

3 months

6 months

Exp Date

01/17 (as

per

calculation

of

Accelerated

Stability

Study)

Minutes for 253rd



0 months

3 months

6 months

0 months

3 months

6 months






Date of

initiation &

implementation

Storage

Conditions

Study

Duration

Study Name Date of

Initiation

Date of Completion

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S-10

S-11

S-12

S-13

14-01-2015

15-01-2015

16-01-2015

17-01-2015





25 ⁰C /60% RH

30 ⁰C /75% RH

45 days

45 days

S-14

S-15

19-01-2015

20-01-2015



50 ⁰C /Ambient

25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S-16

S-17

S-18

21-01-2015

22-01-2015

23-01-2015




40± 2C, 75±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

17-01-2015


(API)lot

no.

A15070018-01

Minutes for 253rd


30± 2C, 65±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26


40± 2C, 75±5 RH

0 months

3 months

6 months

0 months

3 months


30± 2C, 65±5 RH

0 months

3 months

6 months

0 months

3 months


Stability No. Following 13 Stability studies of SOVIR 400mg Tablets Batch No. P.01.01/15 are conducted, out of which only 3

studies S-1,S-2,S-3 are continue and will be completed on 06-08-2016 remaining all are completed. Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 26 weeks








Minutes for 253rd


Approval by:

QC Manager: ---------------------

QA Manager: ---------------------


R&D Manager: -------------------












form

LEDISOVIR 90mg /400 mg Tablets /Ledipasvir+Sofosbuvir/Tablets Batch No. P.02.01/15

Description of pack




Size.

2000

Tablets


Minutes for 253rd










Stability Study

(Proposed)

Storage

Conditions

Study

Duration

Study

Name

(Long Term)

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S1

S2

S3

S4


30 ⁰C /75% RH

45 days

45 days

S5

S6


50 ⁰C /Ambient 25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S7

S8

S9


Conditions

Study

Duration

Study Name


RH

0 months

3 months

6 months

0 months

3 months

6 months


0 months

3 months

6 months

0 months

3 months

6 months






Exp Date

01/17 (as

per

calculation

of

Accelerated

Stability

Study)

Minutes for 253rd


Date of

initiation &

implementation

Storage

Conditions

Study

Duration

Study Name Date of

Initiation

Date of Completion

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S-19

S-20

S-21

S-22

24-01-2015

26-01-2015

27-01-2015

28-01-2015





25 ⁰C /60% RH

30 ⁰C /75% RH

45 days

45 days

S-23

S-24

29-01-2015

30-01-2015



50 ⁰C /Ambient

25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S-25

S-26

S-27

31-01-2015

02-01-2015

03-01-2015




40± 2C, 75±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

24-01-2015


30± 2C, 65±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16


(API)lot

no.

A15070018-01

Minutes for 253rd


Approval by:

QC Manager: ---------------------

Week-20

Week-24

Week-26

Week-20

Week-24

Week-26

40± 2C, 75±5 RH

0 months

3 months

6 months

0 months

3 months


30± 2C, 65±5 RH

0 months

3 months

6 months

0 months

3 months
















Minutes for 253rd


QA Manager: ---------------------


R&D Manager: -------------------

Documents / Data provided by the applicant (M/s Everest Pharmaceuticals Islamabad)


1. COA of API Yes



origin.

Yes




Yes


6. All provided documents will be attested (name, sign and stamp) for

ensuring authenticity of data / documents.

Yes

7. Commitment to continue real time stability study till assigned shelf life of

the product.

Yes

Decision: Mr.Muhammad Usman, CEO presented the data. He informed that firm has requested DRAP, Islamabad four times dated 21-03-

15, 26-03-15, 14-04-15 and 27-04-15 for conduction of GMP inspection and also deposited fee Rs5000/- as per DRAP’s requirement.

Registration Board inquired from representative of QA & LT Division about GMP status of the manufacturer. GMP inspection report was

presented before the Board on 06.10.2015 and tablet section was found satifactoy. Registration Board observed that the stability data

provided by the firm is in accordance with the recommendations of the Board finalized in 251st meeting. Therefore, Board granted approval

of registration of Ledipasvir 90 mg + Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal

Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis

from Central Drugs Laboratory, Karachi before sale of finished product.





Minutes for 253rd


24. M/s Everest Pharmaceuticals Islamabad

Drug Sovir tablets (Sofosbuvir) 400 mg

Source Ruyuan HEC Pharm Co. China


Real Time: 30°C ± 2°C/65% ± 5% RH)

30°C ± 2°C/75% ± 5% RH


Frequency 0, 1,2 3,4, 6, 8,12,16,20,24,26 weeks

0,3,6 months




No. of Batches 03




Registration Board

Remarks Latest GMP inspection report is not

provided, However the firm has submitted

that they have requested FID Islamabad

four times dated 21-03-15, 26-03-15, 14-

04-15 & 27-04-15 for conduction of GMP

inspection and for this purpose they have

submitted 5000/- as per DRAP

requirement.

Firm has submitted letters of two

prescribers. Their comments are as under:

Minutes for 253rd


Prof. Dr. Zafar Iqbal (Ex-Professor of

Medicine Pincipal Sheikh Khalifa Bin

Zayed Medical & Dental College, Lahore

“ Sofosbuvir (Sovir) 400mg along with

Ribavarin (dose adjustment according to

weight of patient) was prescribed to 20

cases of chroniv liver disease. These patiets

were either ineligible to receive interferon

therapy or were Interferon non responders.

The treatment was initiated after propper

pproval of IRB (Institutional Review

Board) of Gujranwala Medical College and

informed consnet. Fourteen patients have

completed four weeks of treatment and

have achieved RVR according to real time

PCR technology. Sofosbuvir ( Sovir) has

proven efficacy and tolerability in these

patients fof Chronic Liver Disease. It will

be a valuable addition to be used in patients

of Chronic Liver Disease.

Prof. Dr. Aftab Mohsin, Profesor of

Medicine, Principal Gujranwala Medical

College.

“In view of urgent need of SOFOSBUVIR

for patients of chronic Hepatitis C, an

approval was sought form IRB of GMC to

be used, as life saving measure in selected

patients of chronic Hepatitis C. Sofosbuvir

(Sovir) tablet along with Ribavirin was

given in 20 cases of chronic hepatitis C,

Minutes for 253rd


who had advanced cirrhosis. They were

either non responder to pegylated interferon

or ineligible for interferon therapy. In all

the cases the drug was well tolerated at

week 1 & week 2 of follow up. The RVR

results will be carried out after completion

of )4 weeks treatmet, done in the end of

March 2015In case of good response on

RVR it will be a valuable addition to be

used in selected cases of Chronic Hepatitis

C”.

The firm has submitted the letter of Doc

Sanjiv Sehgal, Dir Transplant

Hepatology,Medenta , The Medi City,

Gurguan Dehli India stating that use of

Sovir 400 mg tablet in chronic Hepatitis C

three patients with improve outcome and

well toleartetd safety profile.

Minutes for 253rd




form

SOVIR 400 mg Tablets /Sofosbuvir/Tablets Batch No. X.01.08/14

Description of pack




Size.

500 Tablets










Stability Study

(Proposed)

Storage

Conditions

Study

Duration

Study

Name

(Long Term)

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S1

S2

S3

S4


30 ⁰C /75% RH

45 days

45 days

S5

S6


50 ⁰C /Ambient 25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S7

S8

S9

Exp Date

08/16 (as

per

calculation

of

Accelerated

Stability

Study)

Minutes for 253rd



Conditions

Study

Duration

Study Name


RH

0 months

3 months

6 months

0 months

3 months

6 months

Long term conditions (Rea Time) 30± 2C, 65±5 RH

0 months

3 months

6 months

0 months

3 months

6 months






Date of

initiation &

implementation

Storage

Conditions

Study

Duration

Study Name Date of

Initiation

Date of Completion

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S-1

S-2

S-3

S-4

06-08-2014

06-08-2014

06-08-2014

06-08-2014





25 ⁰C /60% RH

30 ⁰C /75% RH

45 days

45 days

S-5

S-6

06-08-2014

20-09-2014



50 ⁰C /Ambient

25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S-7

S-8

S-9

06-08-2014

06-10-2014

06-08-2014




Initial (0 Time)

Week-1

Initial (0 Time)

Week-1

(API)lot

no.

A15070018-01

Minutes for 253rd


40± 2C, 75±5 RH

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

04-08-2014


30± 2C, 65±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26


40± 2C, 75±5 RH

0 months

3 months

6 months

0 months

3 months


30± 2C, 65±5 RH

0 months

3 months

6 months

0 months

3 months


Minutes for 253rd


Approval by:

QC Manager: ---------------------

QA Manager: ---------------------


R&D Manager: -------------------

Stability No. Following 13 Stability studies of SOVIR 400mg Tablets Batch No. X.01.08/14 are conducted, out of which only

3 studies S-1,S-2,S-3 are continue and will be completed on 06-08-2016 remaining all are completed. Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 26 weeks

















Minutes for 253rd




form

SOVIR 400 mg Tablets /Sofosbuvir/Tablets Batch No. P.01.08/14

Description of pack




Size.

2125

Tablets










Stability Study

(Proposed)

Storage

Conditions

Study

Duration

Study

Name

(Long Term)

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S1

S2

S3

S4


30 ⁰C /75% RH

45 days

45 days

S5

S6


50 ⁰C /Ambient 25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S7

S8

S9

Exp Date

08/16 (as

per

calculation

of

Accelerated

Stability

Study)

Minutes for 253rd



Conditions

Study

Duration

Study Name


RH

0 months

3 months

6 months

0 months

3 months

6 months


0 months

3 months

6 months

0 months

3 months

6 months






Date of

initiation &

implementation

Storage

Conditions

Study

Duration

Study Name Date of

Initiation

Date of Completion

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S-10

S-11

S-12

S-13

06-08-2014

06-08-2014

06-08-2014

06-08-2014





25 ⁰C /60% RH

30 ⁰C /75% RH

45 days

45 days

S-14

S-15

06-08-2014

20-09-2014



50 ⁰C /Ambient

25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S-16

S-17

S-18

06-08-2014

06-10-2014

06-08-2014




40± 2C, 75±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6


(API)lot

no.

A15070018-01

Minutes for 253rd


Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

30± 2C, 65±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26


40± 2C, 75±5 RH

0 months

3 months

6 months

0 months

3 months


30± 2C, 65±5 RH

0 months

3 months

6 months

0 months

3 months


Minutes for 253rd


Approval by:

QC Manager: ---------------------

QA Manager: ---------------------


R&D Manager: -------------------



















Minutes for 253rd




form

SOVIR 400 mg Tablets /Sofosbuvir/Tablets Batch No. P.02.08/14

Description of pack




Size.

2125

Tablets










Stability Study

(Proposed)

Storage

Conditions

Study

Duration

Study

Name

(Long Term)

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S1

S2

S3

S4


30 ⁰C /75% RH

45 days

45 days

S5

S6


50 ⁰C /Ambient 25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S7

S8

S9

Exp Date

08/16 (as

per

calculation

of

Accelerated

Stability

Study)

Minutes for 253rd



Conditions

Study

Duration

Study Name


RH

0 months

3 months

6 months

0 months

3 months

6 months


0 months

3 months

6 months

0 months

3 months

6 months






Date of

initiation &

implementation

Storage

Conditions

Study

Duration

Study Name Date of

Initiation

Date of Completion

25 ⁰C /60% RH

30 ⁰C /75% RH

30 ⁰C /65% RH

40 ⁰C /75% RH

24 months

24 months

24 months

6 months

S-19

S-20

S-21

S-22

08-08-2014

08-08-2014

08-08-2014

08-08-2014





25 ⁰C /60% RH

30 ⁰C /75% RH

45 days

45 days

S-23

S-24

08-08-2014

20-09-2014



50 ⁰C /Ambient

25 ⁰C /80% RH

5 ⁰C

45 days

45 days

45 days

S-25

S-26

S-27

08-08-2014

06-10-2014

08-08-2014




40± 2C, 75±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4


(API)lot

no.

A15070018-01

Minutes for 253rd


Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

30± 2C, 65±5 RH

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26

Initial (0 Time)

Week-1

Week-2

Week-3

Week-4

Week-6

Week-8

Week-12

Week-16

Week-20

Week-24

Week-26


40± 2C, 75±5 RH

0 months

3 months

6 months

0 months

3 months


30± 2C, 65±5 RH

0 months

3 months

6 months

0 months

3 months


Minutes for 253rd


Approval by:

QC Manager: ---------------------

QA Manager: ---------------------


R&D Manager: -------------------



















Minutes for 253rd



(M/s Everest Pharmaceuticals Islamabad)


1. COA of API Yes




Yes


details of tests.

Yes




Yes




Yes



Yes

Decision: Mr.Muhammad Usman, CEO presented the data. He informed that firm has requested DRAP, Islamabad four times dated

21-03-15, 26-03-15, 14-04-15 and 27-04-15 for conduction of GMP inspection and also deposited fee Rs5000/- as per DRAP’s

requirement. Registration Board inquired from representative of QA & LT Division about GMP status of the manufacturer. GMP

inspection report was presented before the Board on 06.10.2015 and tablet section was found satifactoy. Registration Board observed

that the stability data provided by the firm is in accordance with the recommendations of the Board finalized in 251st meeting.

Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform

concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first

commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product.

Minutes for 253rd


25. M/s Novartis Pharma Karachi (M/s Strides Acrolabs India)

Brand Name

Composition

Pharmacological group

Manufacturer

Type of Form

Date & Diary

Fee

Demanded price & Pack

size

Manufactured by Remarks

VIRSO Tablets 400mg

Each film coated tablets

contains:

Sofosbuvir…..400mg

Antiviral

Form-5A

Dy No 181, dated 25-08-15

50000/-

38000/- per 28‟s bottle

M/s Strides Arco Lab Ltd,

36/7, Suraj Ajakkanahaali,

Indalavadi, Cross Anekal,

Taluka Banglore, India.

Copy of CoPP submitted.

Firm submitted that original

Copp is in process of

legalization.

Drug VIRSO Tablets 400mg

Source M/s Sequent Scientific Limited India



Real time : 30 C and 75% RH


Frequency 0,1,2,3,6 months (Acc)

0,3,6 months (Real time)

Batch Size 5000 tablets/ batch

Minutes for 253rd


No. of Batches 3

Sample Size Nil

Meeting 252

product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 40⁰c±2⁰c/75% ±5%RH

batch no 2004488-007 mfg. location Strides Bangalore

mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable

expr date Nov-2016 date of incubation 14.01.2015

Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing

HS 130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as

1'DO NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)

Pack size HDPE Container -28‟s

Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20

Period

Test

Description Water

content

limit for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should dissolved

in 15 min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

607670

limit:

NMT

0.50%

Phenol

limit:

NMT

0.50%

any

unspecified

degradation

product

limit: NMT

0.20%

total

impurities

limit NMT

0.8%

assay by HPLC

each film coated

tablet contains

Sofosbuvir 400mg

limit:376.00mg to

420.00mg (94.0%

to 105.00% of label

claim)

Reference A.R

No.

Initial Yellow colored

capsule shaped

bevel edged film

coated tablets

debossed with

"400" on one

side and plain

on other side

2.03% BQL 0.04% BQL BQL BQL BQL BQL 0.02% 0.06% 399.2mg (99.8%) 1080/FD/1500004

1 M Yellow coloured

capsule shaped

bevel edged film

coated tablets

debossed with

"400" on one

side and plain

on other side

1.70% BQL BQL BQL BQL BQL BQL BQL 0.02% 0.02% 400.4mg (100.1%) 1080/FD/1500185

2M Yellow colored 1.75% BQL BQL BQL BQL BQL BQL BQL 0.02% 0.02% 397.6mg (99.4%) 1080/FD/1500245

Minutes for 253rd


capsule shaped

bevel edged film

coated tablets

debossed with

"400" on one

side and plain

on other side

3M Yellow colored

capsule shaped

bevel edged film

coated tablets

debossed with

"400" on one

side and plain

on other side

2.45% BQL BQL BQL BQL BQL BQL BQL 0.05% 0.05% 400.00mg (100.0%) 1080/FD/1500491

product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 40⁰c±2⁰c/75%

±5%RH batch no 2004488-007 mfg. location Strides Bangalore



Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS 130-

35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO NOT

EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)

Pack size HDPE Container -

28‟s


Period

Test

Description Water

content

limit for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should

dissolved in 15

min

Gs-

686965

limit

:NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

607670

limit:

NMT

0.50%

Phenol

limit:

NMT

0.50%

any

unspecified

degradation

product limit:

NMT 0.20%

total

impurities

limit NMT

0.8%

assay by HPLC

each film coated

tablet contains

Sofosbuvir 400mg

limit:376.00mg to

420.00mg (94.0%

to 105.00% of label

claim)

Reference

A.R No.

6M Yellow colored

capsule shaped bevel

edged film coated

tablets debossed with

2.17% 90.5 - 91.9% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 399.6mg

(99.9%)

1080/SS/

1500978

Minutes for 253rd


"400" on one side

and plain on other

side










Period

Test

Description Water

content

limit for

information

only

Dissolution

limit: NLT

80.0% (Q)

of labeled

amount of

Sofosbuvir

should

dissolved in

15 min

Gs-

686965

limit

:NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

607670

limit:

NMT

0.50%

Phenol

limit:

NMT

0.50%

any

unspecified

degradation

product

limit: NMT

0.20%

total

impurities

limit NMT

0.8%

assay by HPLC

each film coated

tablet contains

Sofosbuvir 400mg

limit:376.00mg to

420.00mg (94.0%

to 105.00% of

label claim)

Reference A.R

No.


capsule shaped

bevel edged film

coated tablets

debossed with "400"

on one side and

plain on other side

1.96% 94.6-98.6% BQL BQL BQL BQL BQL BQL 0.03% 0.05% 400.8mg (100.2%) 1080/ss/1500005

1 M Yellow coloured

capsule shaped

bevel edged film

coated tablets

debossed with "400"

on one side and

plain on other side

1.55% 91.5-95.9% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 400.4mg (100.0%) 1080/ss/1500186

2M Yellow colored

capsule shaped

bevel edged film

coated tablets

1.60% 100.8-

102.3%

BQL BQL BQL BQL BQL BQL 0.02% 0.02% 406.4mg (101.6%) 1080/ss/1500246

Minutes for 253rd


debossed with "400"

on one side and

plain on other side

3M Yellow colored

capsule shaped

bevel edged film

coated tablets

debossed with "400"

on one side and

plain on other side

2.04% 92.5-95.8% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 407.30mg

(101.8%)

1080/ss/1500495





Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction

sealing HS 130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text

printed as 1'DO NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD

(10cm)



Period

Test

Description Water

content

limit for

information

only

Dissolution

limit: NLT

80.0% (Q)

of labeled

amount of

Sofosbuvir

should

dissolved in

15 min

Gs-

686965

limit

:NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

607670

limit:

NMT

0.50%

Phenol

limit:

NMT

0.50%

any

unspecified

degradation

product

limit: NMT

0.20%

total

impurities

limit NMT

0.8%

assay by HPLC

each film coated

tablet contains

Sofosbuvir 400mg

limit:376.00mg to

420.00mg (94.0%

to 105.00% of

label claim)

Reference A.R No.

6M Yellow colored

capsule shaped

bevel edged film

coated tablets

debossed with

"400" on one side

and plain on other

side


(100.1%)

1080/SS+O52/1500797

Minutes for 253rd











Period

Test

Description Water

content

limit for

information

only

Dissolution

limit: NLT

80.0% (Q)

of labeled

amount of

Sofosbuvir

should

dissolved in

15 min

Gs-

686965

limit

:NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

607670

limit:

NMT

0.50%

Phenol

limit:

NMT

0.50%

any

unspecified

degradation

product

limit: NMT

0.20%

total

impurities

limit NMT

0.8%

assay by HPLC

each film coated

tablet contains

Sofosbuvir 400mg

limit:376.00mg to

420.00mg (94.0%

to 105.00% of

label claim)

Reference A.R No.


capsule shaped

bevel edged film

coated tablets

debossed with "400"

on one side and

plain on other side

1.80% 93.5-95.5% BQL BQL BQL BQL BQL BQL 0.01% 0.01% 403.6MG

(100.9%)

1080/FD/1500006

1 M Yellow coloured

capsule shaped

bevel edged film

coated tablets

debossed with "400"

on one side and

plain on other side

1.63% 93.1-96.3% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 402.4MG

(100.6%)

1080/SS/2500187

2M Yellow colored

capsule shaped

bevel edged film

coated tablets

debossed with "400"

on one side and

plain on other side

1.64% 97.9-

102.2%

BQL BQL BQL BQL BQL BQL 0.02% 0.02% 406.4MG

(101.6%)

1080/SS/1500247

Minutes for 253rd


3M Yellow colored

capsule shaped

bevel edged film

coated tablets

debossed with "400"

on one side and

plain on other side

1.82% 90.3-93.9% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 401.6mg (100.4%) 1080/SS/1500499

Product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 40⁰c±2⁰c/75% ±5%RH




Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction

sealing HS 130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text

printed as 1'DO NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD

(10cm)



Period

Test

Description Water

content

limit for

information

only

Dissolution

limit: NLT

80.0% (Q)

of labeled

amount of

Sofosbuvir

should

dissolved in

15 min

Gs-

686965

limit

:NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

607670

limit:

NMT

0.50%

Phenol

limit:

NMT

0.50%

any

unspecified

degradation

product

limit: NMT

0.20%

total

impurities

limit NMT

0.8%

assay by HPLC

each film coated

tablet contains

Sofosbuvir 400mg

limit:376.00mg to

420.00mg (94.0%

to 105.00% of

label claim)

Reference A.R No.

6M Yellow colored

capsule shaped

bevel edged film

coated tablets

debossed with

"400" on one side

and plain on other

side

1.99% 94.1-96.1% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 398.4mg (99.6%) 1080/SS+O52/1500986

Product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 30⁰c±2⁰c/65% ±5%RH




Minutes for 253rd


Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS

130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO

NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)



Period

Test

Description water

content limit

: for

information

only

Water content

limit for

information only

Dissolu

tion

limit:

NLT

80.0%

(Q) of

labeled

amount

of

Sofosbu

vir

should

dissolve

d in 15

min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

60766

9 limit:

NMT

0.50%

Gs-607670

limit: NMT

0.50%

Phenol limit:

NMT 0.50%

any

unspecified

degradation

product

limit: NMT

0.20%

total

impurities

limit NMT

0.8%

assay by HPLC

each film

coated tablet

contains

Sofosbuvir

400mg

limit:376.00mg

to 420.00mg

(94.0% to

105.00% of

label claim)



edged film coated


"400" on one side and

plain on other side


(99.8%)

1080/FD/15000

06

3 M Yellow coloured


edged film coated



plain on other side


(100.3%)

1080/SS/25001

87

6M Yellow colored


edged film coated



plain on other side


(99.0%)

1080/SS/15002

47


Minutes for 253rd










Period

Test

Description Water

content limit

for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should dissolved

in 15 min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

60767

0 limit:

NMT

0.50%

Phenol

limit: NMT

0.50%

any

unspecified

degradation

product limit:

NMT 0.20%

total

impurities

limit NMT

0.8%

assay by

HPLC each

film coated

tablet

contains

Sofosbuvir

400mg

limit:376.00

mg to

420.00mg

(94.0% to

105.00% of

label claim)

Reference A.R

No.



edged film coated



plain on other side

2.03% 94.1-98.4% BQL 0.04% BQL BQL BQL BQL 0.02% 0.06% 399.2mg

(99.8%)

1080/FD/15000

06

3 M Yellow coloured


edged film coated



plain on other side


(100.6%)

1080/SS/25001

87

6M Yellow colored


edged film coated



plain on other side


(99.3%)

1080/SS/15002

47

Minutes for 253rd











Period

Test

Description Water

content limit

for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should dissolved

in 15 min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

60767

0 limit:

NMT

0.50%

Phenol

limit: NMT

0.50%

any

unspecified

degradation

product limit:

NMT 0.20%

total

impurities

limit NMT

0.8%

assay by

HPLC each

film coated

tablet

contains

Sofosbuvir

400mg

limit:376.00

mg to

420.00mg

(94.0% to

105.00% of

label claim)

Reference A.R

No.



edged film coated



plain on other side


(100.2%)

1080/FD/15000

05

3 M Yellow coloured


edged film coated



plain on other side


(100.8%)

1080/SS/15004

93

6M Yellow colored


edged film coated




(96.4%)

1080/SS/15009

82

Minutes for 253rd











Period

Test

Description Water

content limit

for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should dissolved

in 15 min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

60767

0 limit:

NMT

0.50%

Phenol

limit: NMT

0.50%

any

unspecified

degradation

product limit:

NMT 0.20%

total

impurities

limit NMT

0.8%

assay by

HPLC each

film coated

tablet

contains

Sofosbuvir

400mg

limit:376.00

mg to

420.00mg

(94.0% to

105.00% of

label claim)

Reference A.R

No.



edged film coated



plain on other side


(100.2%)

1080/FD/15000

05

3 M Yellow coloured


edged film coated



plain on other side


(100.0%)

1080/SS/15004

94

6M Yellow colored


edged film coated



(95.8%)

1080/SS/15009

81

plain on other side

Minutes for 253rd



plain on other side










Period

Test

Description Water

content limit

for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should dissolved

in 15 min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

60767

0 limit:

NMT

0.50%

Phenol

limit: NMT

0.50%

any

unspecified

degradation

product limit:

NMT 0.20%

total

impurities

limit NMT

0.8%

assay by

HPLC each

film coated

tablet

contains

Sofosbuvir

400mg

limit:376.00

mg to

420.00mg

(94.0% to

105.00% of

label claim)

Reference A.R

No.



edged film coated



plain on other side


(100.9%)

1080/FD/15000

06

3 M Yellow coloured


edged film coated



plain on other side


(100.0%)

1080/SS/15004

97

6M Yellow colored


edged film coated


(100.1%)

1080/SS/15009

84

Minutes for 253rd




plain on other side










Period

Test

Description Water

content limit

for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should dissolved

in 15 min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

60767

0 limit:

NMT

0.50%

Phenol

limit: NMT

0.50%

any

unspecified

degradation

product limit:

NMT 0.20%

total

impurities

limit NMT

0.8%

assay by

HPLC each

film coated

tablet

contains

Sofosbuvir

400mg

limit:376.00

mg to

420.00mg

(94.0% to

105.00% of

label claim)

Reference A.R

No.



edged film coated



plain on other side


(100.9%)

1080/FD/15000

06

3 M Yellow coloured


edged film coated



plain on other side


(97.3%)

1080/SS/15004

98

6M Yellow colored



(100.0%)

1080/SS/15009

85

Minutes for 253rd


edged film coated



plain on other side










Period

Test

Description Water

content limit

for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should dissolved

in 15 min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

60767

0 limit:

NMT

0.50%

Phenol

limit: NMT

0.50%

any

unspecified

degradation

product limit:

NMT 0.20%

total

impurities

limit NMT

0.8%

assay by

HPLC each

film coated

tablet

contains

Sofosbuvir

400mg

limit:376.00

mg to

420.00mg

(94.0% to

105.00% of

label claim)

Reference A.R

No.



edged film coated



plain on other side

2.03% 94.1-98.4% BQL 0.04% BQL BQL BQL BQL 0.02% 0.06% 399.2mg

(99.8%)

1080/FD/15000

04

3 M Yellow coloured


edged film coated



plain on other side


(96.4%)

1080/SS/15004

88

6M Yellow colored 2.00% 89.2-93.8% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 397.2mg 1080/SS/15009

Minutes for 253rd



edged film coated



plain on other side

(99.3%) 76










Period

Test

Description Water

content limit

for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should dissolved

in 15 min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

60767

0 limit:

NMT

0.50%

Phenol

limit: NMT

0.50%

any

unspecified

degradation

product limit:

NMT 0.20%

total

impurities

limit NMT

0.8%

assay by

HPLC each

film coated

tablet

contains

Sofosbuvir

400mg

limit:376.00

mg to

420.00mg

(94.0% to

105.00% of

label claim)

Reference A.R

No.



edged film coated



plain on other side


(100.2%)

1080/FD/15000

05

3 M Yellow coloured


edged film coated




(98.4%)

1080/SS/15004

92

Minutes for 253rd











Period

Test

Description Water

content limit

for

information

only

Dissolution

limit: NLT

80.0% (Q) of

labeled amount

of Sofosbuvir

should dissolved

in 15 min

Gs-

686965

limit:

NMT

0.50%

Gs-

331007

limit:

NMT

0.50%

Gs-

566500

limit:

NMT

0.50%

Gs-

607669

limit:

NMT

0.50%

Gs-

60767

0 limit:

NMT

0.50%

Phenol

limit: NMT

0.50%

any

unspecified

degradation

product limit:

NMT 0.20%

total

impurities

limit NMT

0.8%

assay by

HPLC each

film coated

tablet

contains

Sofosbuvir

400mg

limit:376.00

mg to

420.00mg

(94.0% to

105.00% of

label claim)

Reference A.R

No.



edged film coated



plain on other side


(100.9%)

1080/FD/15000

06

3 M Yellow coloured



(98.9%)

1080/SS/15004

96

plain on other side

6M Yellow colored


edged film coated



plain on other side


(97.4%)

1080/SS/15009

80

Minutes for 253rd


edged film coated



plain on other side

6M Yellow colored


edged film coated



plain on other side


(98.8%)

1080/SS/15009

83


(M/s Novartis Pharma, Karachi)


1. COA of API Yes



origin.

Yes (copy GMP issued by

TGA is submitted)




Yes ( raw data is not

submitted)

5. Documents confirming import of API etc. NA



No


product.

Yes

Decision: Registration Board deferred as firm has not provided legalized COPP.

Minutes for 253rd


26. M/s Ferozsons Lab Nowshera

(Harvoni tablets imported from M/s Gilead Sciences USA)

Brand Name

Composition


Manufacturer

Type of Form

Date & Diary, Fee

Demanded MRP & Pack

size

Manufactured by Remarks

Harvoni Tablets

Each film coated tablets

contains:


Ledipasvir…..90mg

Antiviral

Form-5A

Dy No 90, dated 30-07-15

50000/-

43095/- per 28‟s bottle

Manufactured by:

M/s Patheon Inc., 2100

Syntex Court, Mississauga,

Ontario, L5N 7K9, Canada.

Repacked and batch release

by:

M/s Gilead Sciences

Limited, IDA Business &

Technology Park,

Carrigtohill, County Cork,

Ireland.

Product license holder:

M/s Gilead Sciences inc. 333

Lakeside Drive, Foster City,

CA, 94404, USA.

M/s Gilead Sciences

submitted that they have

proposed registration of

alternative trade dress (white

colored) of Harvoni. This

will safeguard the diversion

of Harvoni Tablets intended

for Pakistan to higher

income countries. Harvoni

tablets sold to higher income

countries are orange colored

and alternative trade dress

proposed for Pakistan is

white.

The USFDA COPP

submitted by the firm states

that the product is licensed

in USA but not actually in

market. The justification of

the firm in this regard is

mentioned above.

Minutes for 253rd


Drug (Ledipasvir/ Sofosbuvir 90/400mg tablets)

Source Sofosbuvir: ST Pharm Gyeonggi, South Korae

Ledipasvir: Yuhan Chemicals, South Korea



Time Period 6 months and 6months (White colored tablets)

6 months and 24 months (Orange colored

tablets)

Frequency 0,3,6, (white colored tablets)

0,3,6,9,12,24 months (Orange colored tablets)

Batch Size One batch of 65 Kg ( white colored)

Five batches of 120 Kg ( orange colored)

No. of Batches 6

Sample Size Nil

Meeting 252

Remarks M/s Gileads Science submitted that white

tablets differ from orange tablets only in color

of film coating while maintaining the same

quantitative composition of tablet core, hence

stability data generated on orange tablets are

representative and suitable to support the

storage condition and shelf life.

Sofosbuvir 400 mg/Ledipasvir 90 mg Tablets - Lot DK1307B1

Mfg Site: Patheon, TRO (Mississauga, Ontario, Canada) Batch Size: 66 kg

Mfg Date: October 2013 Fill Quantity: 28 tablets per bottle

Minutes for 253rd


Timepoint

T=0

3 Mo

6 Mo

Appearance

Conf

Conf

Conf

Water Content

2.4

2.2

2.3

Strength (SOF)

99.6

99.2

97.9

Total Deg. (SOF)

0.0

0.0

0.0

Strength (LDV)

99.4

99.5

98.6

Total Deg. (LDV)

0.1

0.1

0.1

Disso (SOF) mean at 30 min

97

97

98

Disso (LDV) mean at 30 min

95

95

96

Fill/Pkg Site: Patheon, TRO (Mississauga, Ontario, Canada)

Fill/Pkg Date: October 2013

Study Init. Date:

Study Duration:

Dec 10, 2013

60 Months

API Lot/Mfg:

Filler:

Desiccant:

Cap: Bottle:

Sofosbuvir, GS-7977(7)6-12002, GS-7977(7)-6-12004, and GS-7977(7)-6-12005 ( ST Pharm, Gyeonggi-do, South Korea)

Ledipasvir solid dispersion, lot 19WG06-50.HE00001 (Hovione, Ireland), sources from GS-5885-03 drug substance, lot PP-1015-

2001 ( Yuhan Chemicals, Inc., Ansan-Shi, Kyuonggi-do, South Korea)

RM-1071, Polyester fiber (coil), 9 gram/yard (Carolina Absorbent Cotton Co.)

RM-11490, 1 gram, Canister with Silica Gel, Labeled (Without Patent No.) (Süd Chemie)

RM-1460, Child Resistant, Polypropylene 38-400 Finish, White, Tekni-Plex HS 130 Innerseal (unprinted), pictorial (Van

Blarcom) RM-1686, 100 mL, White, 38-400 Finish, HDPE, Gilead Debossing, “.050” min. wall (Drug Plastics)

Condition: 30 °C/75% RH Test

Minutes for 253rd


Timepoint

T=0

3 Mo

6 Mo

LD

V

Total Deg. (LDV)

0.1

0.1

0.1

Unspecified LDV related deg

Conf

Conf

Conf

GS-459666

0.14

0.14

0.15

SO

F

Total Deg. (SOF)

0.0

0.0

0.0

Unspecified SOF related deg

Conf

Conf

Conf

GS-606965

GS-331007

GS-566500

GS-607669

GS-607670

Phenol

Condition: 30 °C/75% RH

Test

Sofosbuvir 400 mg/Ledipasvir 90 mg Tablets - Lot DK1307B1

Mfg Site: Patheon, TRO (Mississauga, Ontario, Canada) Batch Size: 66 kg

Mfg Date: October 2013 Fill Quantity: 28 tablets per bottle

Fill/Pkg Site: Patheon, TRO (Mississauga, Ontario, Canada)

Fill/Pkg Date: October 2013

Study Init. Date:

Study Duration:

Dec 10, 2013

6 Months

API Lot/Mfg:

Minutes for 253rd


Timepoint

T=0

1 Mo

3 Mo

6 Mo

Appearance

Conf

Conf

Conf

Conf

Water Content

2.4

2.2

2.1

2.4

Strength (SOF)

99.6

99.9

99.3

98.4

Total Deg. (SOF)

0.0

0.0

0.0

0.0

Strength (LDV)

99.4

100.8

99.4

98.9

Total Deg. (LDV)

0.1

0.2

0.1

0.2

Disso (SOF) mean at 30 min

97

99

98

98

Disso (LDV) mean at 30 min

95

96

96

97

Filler:

Desiccant:

Cap: Bottle:

Sofosbuvir, GS-7977(7)6-12002, GS-7977(7)-6-12004, and GS-7977(7)-6-12005 ( ST Pharm, Gyeonggi-do, South Korea)

Ledipasvir solid dispersion, lot 19WG06-50.HE00001 (Hovione, Ireland), sources from GS-5885-03 drug substance, lot PP-1015-

2001 ( Yuhan Chemicals, Inc., Ansan-Shi, Kyuonggi-do, South Korea)

RM-1071, Polyester fiber (coil), 9 gram/yard (Carolina Absorbent Cotton Co.)

RM-11490, 1 gram, Canister with Silica Gel, Labeled (Without Patent No.) (Süd Chemie)

RM-1460, Child Resistant, Polypropylene 38-400 Finish, White, Tekni-Plex HS 130 Innerseal (unprinted), pictorial (Van

Blarcom) RM-1686, 100 mL, White, 38-400 Finish, HDPE, Gilead Debossing, “.050” min. wall (Drug Plastics)

Condition: 40 °C/75% RH Test

Minutes for 253rd


Timepoint

T=0

1 Mo

3 Mo

6 Mo

LD

V

Total Deg. (LDV)

0.1

0.2

0.1

0.2

Unspecified LDV related deg

Conf

Conf

Conf

Conf

GS-459666

0.14

0.15

0.14

0.15

SO

F

Total Deg. (SOF)

0.0

0.0

0.0

0.0

Unspecified SOF related deg

Conf

Conf

Conf

Conf

GS-606965

GS-331007

GS-566500

GS-607669

GS-607670

trace

Phenol

Condition: 40 °C/75% RH

Test

Decision: Mr.Baqar Hasan, Director presented the data. Registration Board observed that

the registration application was according to Form-5A and stability data provided by the

firm was in accordance with the recommendations of the board finalized in 251st meeting.

Therefore, Board granted approval of registration of Sofosbuvir 400/ Ledipasvir 90 mg

tablets to the firm.

Minutes for 253rd


b. Other molecules / formulations:

27. M/s Brookes Pharma, Karachi

Drug Tomex (Dexmedetomidine) Injection 2 ml




Frequency 0, 1,2, 3, 4,5, 6 months

Batch Size 10 L

No. of Batches 1

Sample Size 39 ampoules

Meeting Deferred in 245th meeting of Registration Board for

stability data as per WHO/ICH guidelines

Accelerated: 40 0 C+2

0C, RH 75+ 5 %

Batch

No.

Period Appearanc

e

(Liquid)

Color

(Colorless

)

Clarity pH

(4.5 – 7.0)

Assay of

Dexmedeto

midine

Related

Substances

(Known: NMT 0.1

%)

(unknown; NMT

0.1 %)

Enantiomeric

Impurity

NMT : 1.0 %

Bacterial

Endotoxin

Test

NMT (79.04

EU/ml )

Sterility Test

(Passes test)

FD/

C1410

Initial Complies Complies Clear 5.85 99.16 % 0.0064% Complies Less than

79.04EU/ml Passes test

FD/

C1410

1st

months

Complies Complies Clear 6.68 97.18 % Not Detected Complies

- -

Minutes for 253rd


FD/

C1410

2nd

Months

Complies Complies Clear 5.93 97.73 Not Detected

Complies

- -

FD/

C1410

3rd

Months

Complies Complies

Clear

6.20 99.12 Not Detected

Complies

- -

FD/

C1410

6th

Months

Complies

Complies

Clear


Complies

Less than

79.04EU/ml

Passes test


Batch

No.

Period Appearanc

e

(Liquid)

Color

(Colorless)

Clarity pH

(4.5 – 7.0)

Assay of

Dexmedeto

midine

Related

Substances

(Known: NMT 0.1

%)

(unknown; NMT

0.1 %)

Enantiomeri

c

Impurity

NMT : 1.0

%

Bacterial

Endotoxin

Test

NMT (79.04

EU/ml )

Sterility Test

(Passes test)

FD/

C1410

Initial Complies Complies Clear 5.85 99.16 % 0.0064% Complies Less than


FD/

C1410

1st

months

Complies Complies Clear 6.64 97.84 % Not Detected Complies

- -

FD/

C1410

2nd

Months

Complies Complies Clear 5.05 97.80 Not Detected

Complies

- -

Minutes for 253rd


FD/

C1410

3rd

Months

Complies Complies

Clear


Complies

- -

FD/

C1410

6th

Months

Complies

Complies

Clear


Complies

Less than

79.04EU/ml

Passes test

Cis-Curon Injection (Cis-AtracuriumBesylate) 5 ml


Real Time: 2-8 C


Frequency 0, 1,2, 3, 6 months

Batch Size 10 L

No. of Batches 1

Sample Size 29 ampoules

Meeting Deferred in 245th meeting of Registration Board


Batch No. Period

Physical

Characteristics

(Colorless to

slighty yellow

or greenish

yellow clear

Clarity Identification

Assay of

Cis-

Atricurium

(as

besylate)

(90-115%)

pH

(3.25-

3.65)

Bacterial

Endotoxin

Test

NMT (79.04

EU/ml )

Sterility Test

(Passes test)

Minutes for 253rd


solution )

FD/E1420 Initial Complies Complies Complies 110.02% 3.35

Less than


FD/E1420 1st Month Complies Complies Complies 105.75% 3.45 - -

FD/E1420 2nd Month Complies Complies Complies 100.75% 3.5 - -

FD/E1420 3rd Month Complies Complies Complies 99.44% 3.54 - -

FD/E1420 6th Month Complies Complies Complies 92.50% 3.61

Less than

79.04EU/ml

Passes test

Significant change noticed in assay of product

Real Time: 2-8 C

FD/E1420 2- 8°C Initial Complies Complies Complies 110.02% 3.35

Less than


FD/E1420 2- 8°C

1st

Month Complies Complies Complies 108.32% 3.43 - -

FD/E1420 2- 8°C

2nd


FD/E1420 2- 8°C

3rd


FD/E1420 2- 8°C

6th

Month Complies Complies Complies 107.34% 3.55

Less than

79.04EU/ml

Passes test

Minutes for 253rd



(M/s Brookes Pharma, Karachi)


1. COA of API Yes



origin.

No




No. Documents for one

batch of each product

provided




Yes


product.

Yes

Decision: Dr.Arif Siddique, Director presented the data with Registration Board. It was observed that the stability data provided

by the firm is not in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, case was deferred till the

applicant completes the requisite information in respect of stability studies.

Minutes for 253rd


28. M/s Global Pharmaceutical, Islamabad

Drug Dlanz Capsule 30 mg

Dlanz Capsule 60 mg



Time Period 12 months and 20 months

Frequency 0,3,6,9,12,20 months

Batch Size 10000 Caps

No. of Batches 03

Sample Size 50 packs per batch

Meeting Registration Board approved the products.

However, the Board advised concerned P E & R

Division and Incharge, PEC to evaluate submitted

stability studies of Zone IVA of Dexlansoprazole

30 & 60mg Capsule. Registration Board authorized

its Chairman for subsequent approval for issuance

of registration letter.

(246 meeting of registration board)

Remarks Assay conducted on spectrophotometer

Minutes for 253rd



1.0 Product Detail:

Product Name /Generic

Name / Dosage Form D-LANZ 30mg (Dexlansoprazole) Batch No B#T-023

Description of Pack

(Container closure

System)

Almost White Spherical DDR Pellets 17% filled “EHG Capsule”

size

„4‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum

Foil, 7‟s Packed in Printed Unit Carton along with leaflet.


Parameter and tests

Mentioned As Per in house specification Mfg.Date Aug-2013

Recommended storage

Condition

Accelerated conditions (Accelerated Stability)

40°±2°C, and 75% ±5% RH (Accelerated Stability) Exp Date July 2015

Date of Completion

& implementation 12/02/2015 API lot NO DLP0113

Stability No 15/R & D /135

Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..

Production Manager………………………………………

R & D Manager………………………………………………

Sample taken for physical test = 100 Capsules

Sample taken for Chemical test = 100 Capsules

Sample taken for Microbiological Test = N/A

Extra Sample (if Needed) = N/A

Total Sample Size 200x3 = 600 Capsules

Minutes for 253rd


Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 11 20

Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014

Mode of Testing (F = Full, P= Partial testing) F P F P F F

Tests (Physical, Chemical Microbiological)

Acceptance Criteria

Storage Condition

(Acce)

Appearance

White Spherical Pellets filled in EHG Capsule Size 4

40°±2°C, 75% RH ±5% RH


Dissolution

0.1 N HCL After 2 hours NMT 10%

3.50% 2.90% 2.90%

Buffer pH7.0

After 1 hours NMT 10% After 3 hours NMT 10%

40°±2°C, 75% RH ±5% RH

49.0% 96.9 %

51.7% 92.8 %

47.1% 92.3 %


40°±2°C, 75% RH ±5% RH


Assay of Dexlansprazole

90.0-110.0%

40°±2°C, 75% RH ±5% RH

106.32% 105.02% 100.00%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion

& implementation 15/02/2015 API Lot No DLP0113


Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014



Acceptance Criteria

Storage Condition

(Acce)

Appearance


40°±2°C, 75% RH ±5% RH


Dissolution


4.39% 2.43% 3.50%

Buffer pH7.0


40°±2°C, 75% RH ±5% RH

48.7% 91.4 %

52.2% 94.7%

48.0%

90.20%


40°±2°C, 75% RH ±5% RH



90.0-110.0%

40°±2°C, 75% RH ±5% RH

105.56% 104.52% 102.27%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014



Acceptance Criteria

Storage Condition

(Acce)

Appearance


40°±2°C, 75% RH ±5% RH


Dissolution

0.1 N HCL After 2 hours NMT 10% 2.7% 2.0% 2.9%

Buffer pH7.0


40°±2°C, 75% RH ±5% RH

51.4% 96.3%

49.0% 92.4%

50.0% 90.3%


40°±2°C, 75% RH ±5% RH



90.0-110.0%

40°±2°C, 75% RH ±5% RH

105.31% 103.6% 102.2%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014



Acceptance Criteria

Storage Condition

(Acce)

Appearance


40°±2°C, 75% RH ±5% RH


Dissolution


Buffer pH7.0


40°±2°C, 75% RH ±5% RH

51.4% 96.3%

49.0% 92.4%

50.0% 90.3%


40°±2°C, 75% RH ±5% RH



90.0-110.0%

40°±2°C, 75% RH ±5% RH

105.08% 104.84% 103.6%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014



Acceptance Criteria

Storage Condition

(Acce)

Appearance


40°±2°C, 75% RH ±5% RH


Dissolution


Buffer pH7.0


40°±2°C, 75% RH ±5% RH

49.0% 96.9%

51.7% 92.8%

47.1% 92.3%


40°±2°C, 75% RH ±5% RH


Assy of Dexlansprazole

90.0-110.0%

40°±2°C, 75% RH ±5% RH

105.34% 106.88% 101.02%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014



Acceptance Criteria

Storage Condition

(Acce)

Appearance


40°±2°C, 75% RH ±5% RH


Dissolution


Buffer pH7.0


40°±2°C, 75% RH ±5% RH

48.7% 91.4%

52.2% 94.7%

48.0%

90.20%


40°±2°C, 75% RH ±5% RH



90.0-110.0%

40°±2°C, 75% RH ±5% RH

105.59% 104.84% 102.04%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition

Long Term conditions (Long Term Stability)

30°±2°C, and 65% ±5% RH (Long Term Stability) Exp Date July 2015

Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013

10/02/2014 10/05/2014 10/08/2014 10/08/2015

Mode of Testing (F = Full, P= Partial testing) F P F P

F F F F


Acceptance Criteria

Storage Condition

(Long)

Appearance


30°±2°C, 65% RH ±5% RH

Complies Complies Complies Complies Complies Complies

Dissolution


2.9% 2.3% 3.1% 3.5% 2.9% 2.9%

Buffer pH7.0


30°±2°C, 65% RH ±5% RH

51.6% 96.6%

49.4% 92.1%

50.3% 90.6%

50.8% 90.9%

46.4% 93.9%

47.6% 91.5%


30°±2°C, 65% RH ±5% RH

Positive Positive Positive Positive Positive Positive


90.0-110.0%

30°±2°C, 65% RH ±5% RH

104.38% 105.86% 105.14% 105.14% 105.14% 105.14%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013

10/02/2014 10/05/2014 10/08/2014 10/08/2015


F F F F


Acceptance Criteria

Storage Condition

(Long)

Appearance


30°±2°C, 65% RH ±5% RH


Dissolution


3.59% 3.01% 2.85% 4.5% 2.9% 2.9%

Buffer pH7.0


30°±2°C, 65% RH ±5% RH

49.3% 96.7%

51.2% 92.6%

46.9% 92.1%

52.5% 91.2%

51.5% 91.4%

47.6% 91.5%


30°±2°C, 65% RH ±5% RH



90.0-110.0%

30°±2°C, 65% RH ±5% RH

106.77% 106.88% 105.14% 104.88% 102.59% 100.77%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013

10/02/2014 10/05/2014 10/08/2014 10/08/2015


F F F F


Acceptance Criteria

Storage Condition

(Long)

Appearance


30°±2°C, 65% RH ±5% RH


Dissolution


4.41% 2.33% 3.80% 3.4% 3.4% 2.0%

Buffer pH7.0


30°±2°C, 65% RH ±5% RH

48.5% 91.36%

51.18% 94.5%

48.3%

90.37% 52.8% 91.8%

51.1% 94.31.%

49.9% 93.8%


30°±2°C, 65% RH ±5% RH



90.0-110.0%

30°±2°C, 65% RH ±5% RH

106.70% 106.123% 104.63% 105.45% 104.65% 103.86%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013

10/02/2014 10/05/2014 10/08/2014 10/08/2015


F F F F


Acceptance Criteria

Storage Condition

(Long)

Appearance


30°±2°C, 65% RH ±5% RH


Dissolution


2.9% 2.3% 3.1% 3.5% 2.9% 2.9%

Buffer pH7.0


30°±2°C, 65% RH ±5% RH

51.6% 96.6%

49.4% 92.1%

50.3% 90.6%

50.8% 90.9%

46.4% 93.9%

47.6% 91.5%


30°±2°C, 65% RH ±5% RH



90.0-110.0%

30°±2°C, 65% RH ±5% RH

106.12% 102.82% 102.82% 102.04% 101.28% 98.20%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013

10/02/2014 10/05/2014 10/08/2014 10/08/2015


F F F F


Acceptance Criteria

Storage Condition

(Long)

Appearance


30°±2°C, 65% RH ±5% RH


Dissolution


3.59% 3.01% 2.85% 4.5% 2.9% 2.9%

Buffer pH7.0


30°±2°C, 65% RH ±5% RH

49.3% 96.7%

51.2% 92.6%

46.9% 92.1%

52.5% 91.2%

51.5% 91.4%

47.6% 91.5%


30°±2°C, 65% RH ±5% RH



90.0-110.0%

30°±2°C, 65% RH ±5% RH

105.86% 102.82% 101.79% 101.53% 102.05% 97.94%



Minutes for 253rd



1.0 Product Detail:



Description of Pack

(Container closure

System)


size




Parameter and tests


Recommended storage

Condition



Date of Completion



Approval by:

QC Manager…………………………………………………..

QA Manager…………………………………………………..


R & D Manager………………………………………………






Minutes for 253rd



Date of Testing 10/08/2013 10/11/2013

10/02/2014 10/05/2014 10/08/2014 10/08/2015


F F F F


Acceptance Criteria

Storage Condition

(Long)

Appearance


30°±2°C, 65% RH ±5% RH


Dissolution


4.41% 2.33% 3.80% 3.4% 3.4% 2.03%

Buffer pH7.0


30°±2°C, 65% RH ±5% RH

48.5% 91.36%

51.18% 94.5%

48.3%

90.37% 52.8% 91.8%

51.1% 94.31%

49.9% 93.8%


30°±2°C, 65% RH ±5% RH



90.0-110.0%

30°±2°C, 65% RH ±5% RH

105.61% 105.86% 102.30% 101.79% 101.79% 98.97%



Minutes for 253rd



(M/s Global Pharma, Islamabad)


1. COA of API Yes



origin.

Yes (Source Vision

Pharma, Islambad)




30 mg Cap: One batch

(Real Time)

30 mg cap: One batch

(Accelerated and real time)

60 mg Cap: One batch real

time

5. Documents confirming import of API etc. NA (Source Vision Pharma,

Islambad)



Yes


product.

No

Decision: Mr.Zamir-ul-Hussan and Muhammad Anis presented the data. Registration Board observed that the stability data


approval of registration of Dexlansoprazole 30 mg and 60 mg capsules to the firm. However, manufacturer will inform concerned

Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial

batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product.

Minutes for 253rd


Following applicants did not submitted stability studies data.

S/N Name and address of

manufacturer / Applicant

Brand Name

(Proprietary name + Dosage Form + Strength)

Composition, Pharmacological Group

Finished product Specification

Type of Form

Initial date, diary

Fee including differential fee

Demanded Price / Pack size

1. M/s Hiranis Pharmaceuticals (Pvt)

Ltd

Plot No. E-145E-149, North West

Industrial Zone, Port Qasim,

Karachi.

SAFLIV Tablet 400 mg

Each film coated tablet contains

Sofosbuvir……400 mg

(Nucleotide Analog NS5B Polymerase Inhibitor)

Manufacturer spec‟s

Form 5 D

16-07-2014

Rs 50,000/-

As per PRC

2. M/s Weatherfolds Pharmaceuticals

69/ 2, Phase II, industrial estate,

Hattar

WINOFOLD Tablet 400 mg




Manufacturer

Form 5 D

15-07-2014

Rs 50000/-

Rs 85,000/ tablet

Blister Pack alu alu 10‟s

3. M/s Winbrains Research

Laboratories Plot No. 69/1, Block B

Phase 1 & 2 Industrial Estate

Hattar, Pakistan.

WINOFOS 400mg Tablets

Each Film Coated Tablet contain:-

Sofosbuvir…400mg

(Anti viral)

(Manufacturer Spec‟s)

Form 5-D

15-07-2014 (330)

Rs. 50,000/-

Rs. 85000/Tablet

4. M/s Wel Wink Pharmaceuticals

G.T Road, Industrial Estate

Gujranwala, Cantt

SOFOWINK 400mg Tablets

Each Film Coated Tablet contain:-

Sofosbuvir…400mg

(Anti viral)

Manufacturer‟s specs

Form 5-D

15-07-2014 (1529)

Rs. 50,000/-

Rs. 85000/Tablet

Minutes for 253rd


5. M/s Helix Pharma (Pvt) Limited,

Hakimson‟s House, A/56, S.I.T.E.

Manghopir Road, Karachi

SOFOVIR Tablets 400mg

Each film coated tablet contains Sofosbuvir…..400mg

Direct Acting Anti-viral

Manufacturer specs

Form-5D

Dated:26/03/14

Dy No: 138-R-II

Rs: 50,000/-

As per PRC/ Pack of 10‟s, 20,s

and 30,s

a. Attested copy of DML/

renewal in case of more than five

years.

b. Evidence of approval of

section.

c. An undertaking to change the

brand name in case of

resemblance with the already

registered brands.

d. An undertaking to submit

Patient information leaflet (PIL),

Summary of poduct

characteristics (SmPC) and

rescribing information as per

approved by drug regulatory

agencies or authorities of FDA,

EMA, TGA, Health Canada and

MHLW

e

6. M/s Saffron Pharma Faisalabad SAFALDI Tablets

Each film coated tablet contains Sofosbuvir……400mg

Anti-viral (NS5B RNA Polymerase Inhibitor)

Manufacturer‟s Specs

Form-5 D

Dated:07-08-14

Dy No: 3122

Rs: 20,000/- dated 12-0914

30000/- dated 18-09-14

As per SRO/ Pack of 28‟s

7. M/s Rotexmedica Pakistan (Pvt)

Limited, Islamabad.

SOLGAR Tablets




Form-5 D

Dated:12-09-14

Dy No: 170

Rs: 50000 dated 07-08-14

30000/- Pack of 10‟s

90000/- Pack of 30‟s

8. M/s OBS Pakistan , Karachi VIRATRON Tablets


Form-5 D

Dated:08-09-14

Dy No: 05

Minutes for 253rd




Rs: 50000 dated 08-09-14

70000/- Pack of 7‟s

2,80000/- Pack of 28‟s

9. M/s Wnsfeild Pharmaceuticals

Plot No.122, Block A, Phase V,

Industrial Estate, Hattar

WINOVIR Tablet 400 mg

Each tablet contains




Form 5 D

15-07-2014

Rs 50,000/-

Rs 85,000/ tablet


10. M/s Titlis Pharma, Lahore FOSBOU 400mg

Tablets

Each Film Coated Tablet contains:-

Sofosbuvir ….400mg

(Antiviral agent)

Manufacturer Spec.s)

Form 5-D

Dy No: 570 dated 19-09-14

Rs.20000/ dated 03-09-14

30000/- 19-09-14

As per SRO

11. M/s Linear Pharma , Islamabad SOBUVIR Tablets 400 mg


Sofosbuvir MS……..400 mg



Form 5 D

Dy No 1732 dated 21-07-14

Rs. 50000 dated 21-07-14

As per SRO

12. M/s Cirin Pharmacuticals Pvt. Ltd

32/2-A, Phase-III, Industrial Estate

Hattar District Haripur, Khyber

Pakhtunkhwa.

Sovir 400mg

Tablets



(Nucleotide analog inhibitor of HCV)

(Manufacturer‟s Spec.s)

Form 5-D

12-03-2014 (855) Rs.50,000/

20000 per tablet / 4×7‟s,

28‟s

13. M/s Martin Dow Limited, Plot No

37, Sector 19, Korangi Industrial

Area, Karachi.

Osvir Tablets 400mg

Each film coated tablet contains sofosbuvir…..400mg

Direct acting antiviral agents


Form-5D

Dated:15/07/2014

Dy No: 1561

Rs: 50,000/-

As per PRC/ Pack of 7‟s,and10‟s

14. M/s Wenovo Pharmaceuticals

Taxila,

Sofovir 400 mg

Tablets



(Anti-Viral)


Form – 5D

Dated 07-03-2014

Dy No. 932

Rs: 50,000/-

Rs.85,000/- per Tablet

Pack of 10‟s

Minutes for 253rd


15. M/s Saibins Pharma, Islamabad Sofvir 400 mg

Tablets



(Anti-Viral)


Form – 5D

Dated 04-08-2014

Dy No. 2801

Rs: 20,000/- dt 04-08-14 and

30000 dated 28-8-2014 (Challan

not attested by STO)

Rs. As per SRO

16. M/s Akson Pharmaceuticals (Pvt)

Ltd.

Plot No. 9-B/1&2, Sector D-1, Old

Industrial Estate,

Mirpur, Azad Kashmir,

Heposbuvir 400mg

Tablets


Sofosbuvir (M.S)….400mg

(Anti-Viral)


Form 5-D

18-07-2014 (518) Rs.50,000/

As per SRO

Pack size:

1 x10‟s,

17. M/s S J & G Fazal Elahi, Karachi Novus 400mg

Tablets


Sofosbuvir (M.S)….400mg

(Anti-Viral)


Form – 5D

Dated 21-07-2014

Dy No. 1803

Rs: 150,000/- dt 21-07-14

Rs. As per SRO

Pack size:

10‟s, 20‟s

18. M/s Dyson Research Laboratories

(Pvt) Ltd., 28 Km, Ferozpur Road,

Lahore.

Sovir 400mg Tablets

Film coated tablets

Each film coated tablet contains:

Sofosbuvir …. 400mg

Direct acting antiviral

Manufacturers specifications

Form 5D

17/07/2014

1628 R&I

17/07/2014

(Rs. 50,000/-)

28‟s As per SRO

19. M/s McOlson Research

Laboratories (Pvt) Ltd., M-2

Pharma Zone, 26 Km, Sharikpur

Road, Sheikhupura.

Sofo 400mg Tablets

Film coated tablets





Form 5D

17/07/2014

1629 R&I

17/07/2014

(Rs. 50,000/-)

28‟s As per SRO

Minutes for 253rd


20. M/s Highnoon, Lahore Sovax 400mg Tablets

Film coated tablets





Form 5D

29/09/2014

1181 R&I

29/09/2014

(Rs. 50,000/-)

28‟s As per SRO

21. M/s Welward Pharmaceuticals

Plot No. 3, Block A, Phase I-II,

Industrial Estate, Hattar

Sofoward Tablet 400 mg





Form 5 D

15-07-2014

Rs 50,000/-

Rs 85,000/ tablet


22. M/s Shaigan Pharma, Rwp. Vebuvir 400mg

Tablets



(Anti-Hepatitis C)


Form 5-D

27-08-2014 (3845) Rs.50,000/

Not mentioned

23. M/s Pearl Pharma, Islamabad Hepavir 400mg

Tablets



(Anti-Hepatitis C)


Form 5

26-09-2014

(993)

Rs 20,000/-

As per SRO

24. M/s Akson Pharmaceuticals, Pvt

Limited, Mirpur.

LIVERSOF Tablets



Ledipasvir….90mg

Antiviral

Manufacturer

Form 5D

Dy No. 1720 dated 18-07-14

50000/-

As per SRO

25. M/s. Rasco Pharma Lahore HC-BUVIR Tablets

Each film coated tablet contains:-

Sofosbuvir…….400mg

Antiviral

Manufacturer

Form-5

Dy. No.118. Date.4-2-2015

Not mentioned/As per SRO

20000/-2-02-2015

Minutes for 253rd


26. M/s. The Schazoo Pharma,Lahore LAVIE Tablets



Antiviral

Manufacturer

Form-5

Dy.No.1010 Reg-V /11-6-2015

Rs.1190/ per tab, Rs.33300/4x7‟s

20,000/-28-05-2015

27. M/s. Pharmedic Laboratories

Lahore

HEPAVIR Tablets



Antiviral

Manufacturer

Form-5

Dy.No.238 Reg-V /10-6-2015

Rs.55000.00/28‟s

20,000/-29-05-2015

28. M/s. Friends Pharma Lahore SOFOVIR Tablets



Antiviral

Manufacturer

Form-5D

Dy. No. 133 Date.3-3-2015

As Per SRO/10‟s

50000/-3-03-2015

29. M/s. Seatle (Pvt) Ltd, Lahore ISUVIR Tablets



Antiviral

Manufacturer

Dy.No.164 Date.26-1-2015

As per brand leader/7‟s,14‟s,28‟s

20000/-23-01-2015

30. M/s. English Pharma Lahore ESOVIR Tablets



Antiviral

Manufacturer

Form-5

Dy. No. 207 date 29-4-2015

As Per SRO/10‟s

20,000/- 28-4-2015

31. -do- LEDSOVIR Tablets

Each film tablet contains:-


Ledipasvir….90mg

Antiviral

Manufacturer

Form-5

Dy. No. 208 date 29-4-2015

As Per SRO/10‟s

20,000/- 28-4-2015

32. M/s Neutro Pharma Lahore NUVALDI Tablets



Antiviral

Manufacturer

Form-5D

Dy. No. 531 date 08-09-2014

As Per SRO

50,000/-

Minutes for 253rd


Decision: Board decided to defer all the cases till provision of scientifically rationale lab scale stability data in accorndace with the

guidelines approved by the Board in 251st meeting.

33. M/s. Wilshire Labs; Lahore Ziqar Tablet


Sofosbuvir ……………………….. 400mg

Form-5D

Dy. No. 469 date 25-08-2014

As Per SRO

50,000/-

34. M/s. Novamed Pharmaceutical

Lahore



Form-5

As Per SRO

35. M/s. Ferozsons Nowshera KPK Each film coated tablet contains:-


Form-5

As Per SRO

Minutes for 253rd


Case No.02: Grant of registrations to New Molecules.

a. Locally manufactured.

Incharge PEC

S/

N

Name and

address of

manufacturer

/ Applicant

Brand Name

(Proprietary name +

Dosage Form + Strength)

Composition

Pharmacological Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

Remarks on

the

formulation

(if any)

including

Internationa

l status in

stringent

drug

regulatory

agencies /

authorities

Me-too

status

GMP status

as depicted

in latest

inspection

report (with

date) by the

Evaluator

Remarks by

Evaluator

1. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Esli 800mg Tablets

Each Tablet contains:

Eslicarbazepine

Acetate….800mg

(Anti-epileptic)

Form-5-D

Dy. No: 1639

dated 27-08-

2013

50,000/- dated

27-08-2013

Rs.825/Tab

Aptiom

800mg by

Sunovion

Pharms INC

(FDA)

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

2. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Esli 400mg Tablets


Eslicarbazepine

Acetate….400mg

(Anti-epileptic)

Form-5-D

Dy. No: 1637

dated 27-08-

2013

50,000/- dated

27-08-2013

10‟s,20‟s,30‟s

Rs.6,000/-

Rs.12,000/-

Rs.18,000/-

Aptiom

400mg by

Sunovion

Pharms INC

(FDA)

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

Minutes for 253rd


3. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Esli 200mg Tablets


Eslicarbazepine

Acetate….200mg

(Anti-epileptic)

Form-5-D

Dy. No: 1638

dated 27-08-

2013

50,000/- dated

27-08-2013

10‟s,20‟s,30‟s

Rs.4,000/-

Rs.8,000/-

Rs.12,000/-

Aptiom

200mg by

Sunovion

Pharms INC

(FDA)

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

4. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Rasidon 120mg


Lurasidone

HCl………..…120mg

(Antipsychotic)

Form-5-D

Dy. No: 139

dated 13-02-

2013

50,000/- dated

13-02-2013

10‟s,20‟s30‟s

Rs.16,000/-

Rs.32,000/-

Rs.48,000/-

Latuda

Sunovion

Pharm INC

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

5. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Rasidon 80mg


Lurasidone

HCl………..…80mg

(Antipsychotic)

Form-5-D

Dy. No: 141

dated 13-02-

2013

50,000/- dated

13-02-2013

10‟s,20‟s30‟s

Rs.15,000/-

Rs.30,000/-

Rs.45,000/-

Latuda

Sunovion

Pharm INC

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

6. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Rasidon 40mg


Lurasidone

HCl………..…40mg

(Antipsychotic)

Form-5-D

Dy. No: 180

dated 13-02-

2013

50,000/- dated

13-02-2013

10‟s,20‟s30‟s

Rs.14,000/-

Rs.28,000/-

Rs.42,000/-

Latuda

Sunovion

Pharm INC

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

7. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Rasidon 20mg


Lurasidone

HCl………..…20mg

(Antipsychotic)

Form-5-D

Dy. No: 183

dated 13-02-

2013

50,000/- dated

13-02-2013

Latuda

Sunovion

Pharm INC

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

Minutes for 253rd


10‟s,20‟s30‟s

Rs.13,000/-

Rs.26,000/-

Rs.39,000/-

WHO

guidelines.

8. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Canaglu 100mg Tablets

Each film coated Tablet

contains:

Canagliflozin……100mg

(Anti-Diabetic)

Form-5-D

Dy. No: 1585

dated 23-08-

2013

50,000/- dated

23-08-2013

10‟s/Rs.6,500/-

Invokana

FDA

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

9. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Canaglu 300mg Tablets


contains:

Canagliflozin……300mg

(Anti-Diabetic)

Form-5-D

Dy. No: 1582

dated 23-08-

2013

50,000/- dated

23-08-2013

10‟s/Rs.7,500/-

Invokana

FDA

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

10. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Dapa 10mg Tablets


contains:

Dapagliflozin………10mg

(Anti-Diabetic)

Form-5-D

Dy. No: 1584

dated 23-08-

2013

50,000/- dated

23-08-2013

10‟s/Rs.7,000/-

Farxiga

(Astrazeneca

ab) 50mg,

10mg FDA

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

11. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Dapa 5mg Tablets


contains:

Dapagliflozin………5mg

(Anti-Diabetic)

Form-5-D

Dy. No: 1583

dated 23-08-

2013

50,000/- dated

23-08-2013

10‟s/Rs.5,500/-

Farxiga

(Astrazeneca

ab) 50mg,

10mg FDA

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

12. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Apix 2.5mg Tablets

Tablet.


contains:

Apixaban…….2.5mg

(Anticoagulant)

Form-5-D

Dy. No: 400

dated 06-11-

2013

50,000/- dated

06-11-2013

Eliquis

2.5mg, 5mg

(BMS) FDA

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

Minutes for 253rd


10‟s,20‟s,60‟s

Rs.475/tablet-

WHO

guidelines.

13. M/s Hilton

Pharma (Pvt.)

Ltd. 13, Sector

15, Korangi

Industrial

Area, Karachi.

Apix 5mg Tablets

Tablet.


contains:

Apixaban…….5mg

(Anticoagulant)

Form-5-D

Dy. No: 102

dated 07-02-

2014

50,000/- dated

07-02-2014

10‟s,20‟s,60‟s

Rs.516.58/tablet

-

Eliquis

2.5mg, 5mg

(BMS) FDA

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

14. M/s Getz

Pharma,

(Private)

Limited 29-

30/27, Korangi

Industrial Area

Karachi.

Lansodex Capsule 60mg

Delayed Release Capsules

Each delayed release

contains:

Enteric coated pellets of

Dexlansoprazole…….60mg

PPI (Proton Pump

Inhibitor)

Form-5-D

Dy. No: Not

mentioned.

dated 19-10-

2011

Rs.15,000/-

dated 30-07-

2013

Rs. 5,000/-

06-08-2015

Rs.30,000/-

14‟s/Rs.1680/-

Dexlanxilant

30mg, 60mg

Takeda

Pharms FDA.

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

15. M/s Getz

Pharma,

(Private)

Limited 29-

30/27, Korangi

Industrial Area

Karachi.

Lansodex Capsule 30mg

Delayed Release Capsules

Each delayed release

contains:

Enteric coated pellets of

Dexlansoprazole…….30mg

PPI (Proton Pump

Inhibitor)

Form-5-D

Dy. No: Not

mentioned.

dated 19-10-

2011

Rs.15,000/-

dated 30-07-

2013

Rs. 5,000/-

06-08-2015

Rs.30,000/-

14‟s/Rs.840/-

Dexlanxilant

30mg, 60mg

Takeda

Pharms FDA.

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

16. M/s Getz

Pharma,

(Private)

Limited 29-

30/27, Korangi

Industrial Area

Karachi.

Previr

Film coated tablet.

Each film coated tablet

contains:

Telaprevir……750

Anti viral (HCV serine

protease inhibitors)

Form-5-D

Dy. No: Not

mentioned.

dated 31-08--

2013

15,000/-

Rs.35,000/-

dated 30-08-

2013

10‟s,30‟s

Rs.10,000/-

Inspection.

15-12-2010

International

status not

confirmed

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

Minutes for 253rd


Rs.30,000/-

17. M/s Getz

Pharma,

(Private)

Limited 29-

30/27, Korangi

Industrial Area

Karachi.

Previr

Film coated tablet.


contains:

Telaprevir……375

Anti viral (HCV serine

protease inhibitors)

(Getz specs)

Form-5-D

Dy. No: Not

mentioned.

dated 31-08-

2013

15,000/-

Rs.35,000/-

dated 30-07-

2013

10‟s,30‟s

Rs.5,000/-

Rs.15,000/-

Incivek by

Vertex

pharms

FDA:375mg

Inspection.

15-12-2010

Stability

Studies

conducted

under the Zone

IV-A

conditions as

per ICH /

WHO

guidelines.

18. M/s Searl

Company

Limited. 1st

Floor N.I.C

Building

Abbasi

Shaheed Road

Off: Shahrah-

E-Faisal

Karachi.

Dexlans 60mg Capsule

Capsule.

Each Capsule contains:

Dexlansoprazole…..60mg

(Anti Ulcerant)

Form-5-D

Dy. No: Not

mentioned.

Dated. 08-10-

2013

Rs.50,000/-

14‟s,/Rs.15,000/

-

Dexlanxilant

30mg, 60mg

Takeda

Pharms FDA.

The innovator

product is

delayed

release capsule

while firm has

not applied it.

19. M/s Searl

Company

Limited. 1st

Floor N.I.C

Building

Abbasi

Shaheed Road

Off: Shahrah-

E-Faisal

Karachi.

Dexlans 30mg Capsule

Capsule.


Dexlansoprazole…..30mg

(Anti Ulcerant)

Form-5-D

Dy. No: Not

mentioned.

Dated. 08-10-

2013.Rs.50,000/

-

14‟s,

Rs.880/-

Dexlanxilant

30mg, 60mg

Takeda

Pharms FDA.

The innovator

product is

delayed

release capsule

while firm has

not applied it.

20. M/s

Remington

Pharmaceutica

l Industries

(Pvt.) Ltd.

18km Multan

Road, Lahore

Amgydex ST

Ophthalmic Suspension

Each ml contains:-

Tobramycin

U.S.P………3.0mg

Dexamethasone

U.S.P…..0.5mg

(Antibiotic &

Corticosteroid)

Form-5D

Dy. No: not

mentioned

Rs.15,000/-

Dated. 30-06-

2012.

35,000/- dated

30-07-2013

5ml, 10ml,15ml

Rs.300/-

M/s

Remington

Pharmaceutica

l Industries

(Pvt.) Ltd.

18km Multan

Road, Lahore

21. M/s

Remington

Pharmaceutica

l Industries

(Pvt.) Ltd.

Moxear-D

Ear Drops

Each ml contains:-

Moxifloxacin

Hydrochloride B.P

Form-5D

Dy. No: 3420

Rs.15,000/-

Dated. 02-05-

2012.

M/s

Remington

Pharmaceutica

l Industries

(Pvt.) Ltd.

Minutes for 253rd


18km Multan

Road, Lahore

equivalent to

Moxifloxacin..5.0mg

Dexamethasone Sodium

Phosphate U.S.P eq to

Dexamethasone

Phosphate….1.0mg

(Antibiotic &

Corticosteroid)

35,000/- dated

30-07-2013

5ml, 10ml,15ml

Rs.300/-

18km Multan

Road, Lahore

22. M/s

Remington

Pharmaceutica

l Industries

(Pvt.) Ltd.

18km Multan

Road, Lahore

Dorolol

Eye Drops

Each ml contains:-

Dorzolamide Hydrochloride

U.S.P eq to

Dorzolamide…………20m

g

Timolol Maleate U.S.P. eq.

to

Timolol……………..5mg

Brimonidine

Tartrate……2mg

(Carbonic Anhydrase

Inhibitor)

Form-5D

Dy. No: 3420

Rs.15,000/-

Dated. 02-05-

2012.

35,000/- dated

30-07-2013

5ml, 10ml,15ml

Rs.1100/-

M/s

Remington

Pharmaceutica

l Industries

(Pvt.) Ltd.

18km Multan

Road, Lahore

b. Finished Import.

Incharge PEC

S/

N

Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form + Strength)

Composition


Finished product

Specification

Type of

Form

Initial date,

diary

Fee

including

differential

fee

Demanded

Price / Pack

size

Remarks on

the

formulation

(if any)

including

Internationa

l status in

stringent

drug

regulatory

agencies /

authorities

Me-too

status

GMP status

as depicted

in latest

inspection

report (with

date) by the

Evaluator

Remarks by

Evaluator

Minutes for 253rd


23. M/s Novartis

Pharma

(Pakistan)

Limited, 15

West Wharf P.O

Box 100

Karachi.

Novartis Pharma

Stein AG, Stien,

Switzerland.

Ultibro Breezhaler


Indacaterol 110mcg and

Glycopyrronium 50mcg

(143 microgram

glycopyrrnium bromide

equivalent to 110

micrograms

glycopyrrnium)

(Bronchodilator)

Form-5 (A)

Dy. No: 84

dated 22-01-

2014

100,000/-

dated 22-01-

2014

30‟s

Rs.6,424/-

Ultibro

Breezhaler

Novartis

Europharm

Limited.

EMA

COPP was issued

on 23-01-2015

24. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

LTS Lohmann

Therapie-

System AG,

Lohmannstr

2,D-56626

Andernach,

Germany

Neupro ® 2mg/24hr

Each patch of 10cm2

contains 4.5mg Rotigotine

(UCB Specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 386

dated 19-05-

2014

100,000/-

dated 19-05-

2014

28‟s

Rs.7,115/-

Neupro UCB

INC

COPP is issued

on dated: 30-08-

2013

25. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

LTS Lohmann

Therapie-

System AG,

Lohmannstr

2,D-56626

Andernach,

Germany

Neupro ® 4mg/24hr

Each patch of 20cm2


(UCB Specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 387

dated 19-05-

2014

100,000/-

dated 19-05-

2014

28‟s

Rs.14,225/-

Neupro UCB

INC

COPP is issued

on dated: 30-08-

2013

26. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

LTS Lohmann

Therapie-

System AG,

Lohmannstr

2,D-56626

Andernach,

Germany

Neupro ® 6mg/24hr

Each patch of 30cm2


(UCB Specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 384

dated 19-05-

2014

100,000/-

dated 19-05-

2014

28‟s

Rs.21,340/-

Neupro UCB

INC

COPP is issued

on dated: 30-08-

2013

27. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

Neupro ® 8mg/24hr

Each patch of 40cm2


(UCB Specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 380

dated 19-05-

2014

Neupro UCB

INC

COPP is issued

on dated: 30-08-

2013

Minutes for 253rd


LTS Lohmann

Therapie-

System AG,

Lohmannstr

2,D-56626

Andernach,

Germany

100,000/-

dated 19-05-

2014

28‟s

Rs.28,450/-

28. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

M/s Aesica

Pharmaceutical

GmbH

Galileistrasse 6

08056

Zwickau

Germany.

Vimpat film coated tablet

150mg

Tablet


contains:

Lacosamide….150mg

(UCB specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 131

dated 20-09-

2013

100,000/-

dated 20-09-

2013

56‟s

Rs.40,230/-

Vimpat UCB

INC FDA

50mg,

100mg,

150mg,

200mg

Lacolep by

Hilton Pharma

Karachi.

The product

is locally

registered in

50mg,

100mg,

150mg and

200mg.

COPP was

issued on 22-

11-2012

GMP was

issued on 27-

11-2012

29. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

M/s Aesica

Pharmaceutical

GmbH

Galileistrasse 6

08056

Zwickau

Germany.


50mg

Tablet


contains:

Lacosamide….50mg (UCB

specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 133

dated 20-09-

2013

100,000/-

dated 20-09-

2013

14‟s

Rs.3,352/-

Vimpat UCB

INC FDA

50mg,

100mg,

150mg,

200mg

Lacolep by

Hilton Pharma

Karachi.

The product

is locally

registered in

50mg,

100mg,

150mg and

200mg.

COPP was

issued on 22-

11-2012

GMP was

issued on 27-

11-2012

30. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

M/s Aesica

Pharmaceutical

GmbH

Galileistrasse 6

08056

Zwickau


100mg

Tablet


contains:

Lacosamide….100mg

(UCB specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 128

dated 20-09-

2013

100,000/-

dated 20-09-

2013

56‟s

Rs.26,820/-

Vimpat UCB

INC FDA

50mg,

100mg,

150mg,

200mg

Lacolep by

Hilton Pharma

Karachi.

The product

is locally

registered in

50mg,

100mg,

150mg and

200mg.

Minutes for 253rd


Germany. COPP was

issued on 22-

11-2012

GMP was

issued on 27-

11-2012

31. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

M/s Aesica

Pharmaceutical

GmbH

Galileistrasse 6

08056

Zwickau

Germany.


200mg

Tablet


contains:

Lacosamide….200mg

(UCB specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 132

dated 20-09-

2013

100,000/-

dated 20-09-

2013

56‟s

Rs.53,640/-

Vimpat UCB

INC FDA

50mg,

100mg,

150mg,

200mg

Lacolep by

Hilton Pharma

Karachi.

The product

is locally

registered in

50mg,

100mg,

150mg and

200mg.

COPP was

issued on 22-

11-2012

GMP was

issued on 27-

11-2012

32. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

M/s UCB

Manufacturing

Inc. 331 Clay

Road (755

Jefferson Road)

Rochester, NY

14623 USA

Vimpat Syrup 10mg/ml

Syrup

Each ml contains:


specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 129

dated 20-09-

2013

100,000/-

dated 20-09-

2013

200ml

Rs.14,268/-

Vimpat UCB

INC

10mg/ml oral

solution

COPP was

issued on

dated. 22-11-

2011 by

Eupeon

Medicines

Agency

33. M/s AGP

(Private)

Limited. B-23

S.I.T.E Karachi.

M/s UCB

Pharma SA

Chemin du

foriest B 1420

Braine-Alleud

Belgium

Vimpat 10mg/ml solution

for infusion

Infusion

Each ml of solution

contains:


specs)

(Antiepileptic)

Form-5 (A)

Dy. No: 130

dated 20-09-

2013

100,000/-

dated 20-09-

2013

20ml

Rs.10,818/-

Vimpat UCB

INC

10mg/ml IV

infusion

Photocopy of

COPP dated.

22-11-2012

34. M/s Pfizer

Pakistan

Limited, 12

Dockyard Road,

West Wharf,

Karachi.

Xeljanz

Tablet

Each tablet contains:

Tofacitinib…….5mg

(Factor Xa Inhibitor)

Form-5 (A)

Dy. No: 170

dated 27-09-

2013

Xeljanz by

PF Prism CB

Storage

conditions

are not as per

innovator.

COPP is

issued by

Minutes for 253rd


Pfizer

Manufacturing

Deutschland

GmbH

Betriebsstatte

Freiburg

Mooswaldallee

179090 Freiburg

Germany.

50,000/-

dated 27-09-

2013

Not

mentioned.

Swissmedic

and does not

provide

information

of

manufacturin

g / packaging

to be done at

USA.

Label shows

the product is

manufactured

in Ireland

while as per

application it

is

manufactured

at Germany

and USA.

Last

Inspection

Report

conducted by

the concerned

Regulatory

Authority for

manufacturin

g process at

USA.

35. M/s Pfizer

Pakistan

Limited, 12

Dockyard Road,

West Wharf,

Karachi.

Pfizer

Manufacturing

Deutschland

GmbH

Betriebsstatte

Freiburg

Mooswaldallee

179090 Freiburg

Germany.

Xeljanz

Tablet


Tofacitinib…….10mg

(Factor Xa Inhibitor)

Form-5 (A)

Dy. No: 169

dated 27-09-

2013

50,000/-

dated 27-09-

2013

Not

mentioned.

Xeljanz

10mg is not

FDA

approved.

Storage

condition are

not as per

innovator.

COPP is

issued by

Swissmedic

and does not

provide

information

of

manufacturin

g / packaging

to be done at

USA.

Label shows

the product is

manufactured

in Ireland

while as per

application it

is

manufactured

Minutes for 253rd


at Germany

and USA.

Last

Inspection

Report

conducted by

the concerned

Regulatory

Authority for

manufacturin

g process at

USA.

36. M/s Bayer

Pakistan (Pvt.)

Limited.

M/s Bayer

Pharma AG

51368

Leverkusen

Germany.

Stivarga (Regorafenib)

40mg film coated tablets.

Film coated tablets.


contains.

Regorafenib……40mg

(Regorafenib is a protein

kinase inhibitor with the

ATC code L01XE21.)

Form-5 (A)

Dy. No: 370

dated 03-12-

2013

50,000/-

dated 03-12-

2013

To be

submitted

latter.

GMP

inspection

conducted

December 14

to 16, 2010

by German

Authority.

Certificate of

medicinal

product dated 18-

09-2013 issued

by EMA is

provided.

37. M/s Abbott

Laboratories,

Karachi.

M/s Ferrer

Internacional.

S.A. Joan

Buscalla 1-9

08173-Sant

Cugat del Valles

(Barcelona)

Spain

Nucleo CMP Forte

Capsules.

Capsules.

Each Capsule contains.

Cytidine……5mg

Uridine…..1.33mg

(Musculoskeletal System)

Form-5 D

Dy. No: 314

dated 11-11-

2013

50,000/-

dated 11-11-

2013

To be

forwarded.

GMP issued

on February

09-2011, by

Spanish

Government

COPP issued on

07-19-2013.

Stability studies

conducted at

30ºC / 60%

38. M/s Sanofi-

eventis Pakistan

Limited. Plot

No.23, Sector

No.22, Korangi

Industrial Area s

Plot No.23,

Sector No.22,

Korangi

Industrial Area

Karachi.

M/s Sanofi-

Aventis

Deutschland

GmbH,

Industriepark

Lyxumia.

Solution of injection.

Each dose of 0.2 ml

contains.

Lixisenatide……20mg

(ATC code: A10BX10)

Form-5 A

Dy. No: 763

dated 28-06-

2013

100,000/-

dated 28-06-

2013

1‟s/

Rs.7506.8

Lyxumia

(Sanofi

Aventis

EMA

approved)

FDA approval is

delayed sighting

internal data from

cardiovascular

risks study.

Minutes for 253rd


Hoechst 65926

Frankfurt am

Main Germany

39. M/s Sanofi-

eventis Pakistan

Limited. Plot

No.23, Sector

No.22, Korangi

Industrial Area s

Plot No.23,

Sector No.22,

Korangi

Industrial Area

Karachi.

M/s Sanofi-

Aventis

Deutschland

GmbH,

Industriepark

Hoechst 65926

Frankfurt am

Main Germany

Lyxumia.


Each dose of 0.2 ml

contains.

Lixisenatide……10mg

(ATC code: A10BX10)

Form-5 A

Dy. No: 761

dated 28-06-

2013

100,000/-

dated 28-06-

2013

1‟s/

Rs.7506.8

Lyxumia

(Sanofi

Aventis

EMA

approved)

FDA approval is

delayed sighting

internal data from

cardiovascular

risks study.

40. M/s Sanofi-

eventis Pakistan

Limited. Plot

No.23, Sector

No.22, Korangi

Industrial Area s

Plot No.23,

Sector No.22,

Korangi

Industrial Area

Karachi.

M/s Sanofi-

Aventis

Deutschland

GmbH,

Industriepark

Hoechst 65926

Frankfurt am

Main Germany

Lyxumia.


Lyxumia® Pen-injector is

available in two different

dosage strengths: 10µg and

20µg per 0.2ml

administration volume.

Body and cap are provided

in two different colors:

green (10µg) and burgundy

(20µg)

(ATC code: A10BX10)

Form-5 A

Dy. No: 762

dated 28-06-

2013

100,000/-

dated 28-06-

2013

1+1=2‟s/

Rs.15,013.6/

-

Lyxumia

(Sanofi

Aventis

EMA

approved)

FDA approval is

delayed sighting

internal data from

cardiovascular

risks study.

41. M/s Novartis

Pharma

(Pakistan)

Limited

Veltezom 3.5mg/Vial

Powder for Solution for

Injection.

Vial Injectable.

Each Vial contains.

Form-5

Dy. No: 296

dated 31-03-

2014

50,000/-

Velcade

Millennium

Pharms

COPP issued on

dated. 05-01-

2013

Minutes for 253rd


M/s Sandoz

Onco Therapies

Limited Plot No.

284,

Bommasandra-

Jigani Link

Road , Industrial

Area,

AnekalTaluk,

Bangalore 560,

105 India.

Brotezomib……3.5mg

(Antineoplastic agent)

dated 25-07-

2013

1‟s/

Rs.20,317/-

42. M/s

GlaxoSmithKlin

e Pakistan

Limited 35-

Dockyard Road,

West Wharf,

Karachi.

M/s Glaxo

Operations UK

Limited, Ware

UK

Relvar Ellipta

Dry Powder Inhaler

Each pre-dispensed dose

contains.

Fluticasone

furoate…….100mcg

Vilanterol (as

trifenatate)…25mcg

(Potent Corticosteroid plus

long acting beta-2

adrenergic agonist for the

maintenance treatment of

asthma and COPD)

Form-5A

Dy. No: 275

dated 04-04-

2014

50,000/-

dated 04-04-

2014

Will be

submitted

later

COPP issued on

dated. 06-02-

2014

43. M/s

GlaxoSmithKlin

e Pakistan

Limited 35-

Dockyard Road,

West Wharf,

Karachi.

M/s Glaxo

Operations UK

Limited, Ware

UK

Relvar Ellipta

Dry Powder Inhaler


contains.

Fluticasone

furoate…….200mcg

Vilanterol (as


(Potent Corticosteroid plus

long acting beta-2

adrenergic agonist for the

maintenance treatment of

asthma and COPD)

Form-5A

Dy. No: 275

dated 04-04-

2014

50,000/-

dated 04-04-

2014

Will be

submitted

later

COPP issued on

dated. 06-02-

2014

44. M/s

GlaxoSmithKlin

e Pakistan

Limited 35-

Dockyard Road,

West Wharf,

Karachi.

M/s Glaxo

Operations UK

Limited, Ware

UK

Anoro Ellipta

Dry Powder Inhaler


contains.

Umeclidinium…….62.5mc

g

Vilanterol (as


(Long acting muscarinic

antagonist (LAMA), and a

long-acting beta-2 agonist

(LABA)

Form-5A

Dy. No: 693

dated 18-09-

2014

50,000/-

dated 18-09-

2014

Will be

submitted

later

COPP issued on

dated. 06-08-

2014

Minutes for 253rd


45. M/s

GlaxoSmithKlin

e Pakistan

Limited 35-

Dockyard Road,

West Wharf,

Karachi.

M/s Glaxo

Operations UK

Limited, Ware

UK

Incruse Ellipta

Dry Powder Inhaler


contains.

Umeclidinium (equivalent

to 74.2 mcg of

umecidinium

bromide)…….62.5mcg

(Long acting muscarinic

antagonist (LAMA)

Form-5A

Dy. No: 234

dated 15-12-

2014

50,000/-

dated 15-12-

2014

Will be

submitted

later

COPP issued on

dated. 28-10-

2014

46. M/s Mazaton

Pharmaceuticals

(Pvt) Ltd.

720-X, Phase

III, D.H.A,

Lahore

M/s

Laboratories

Galderma Z.I.

Montdesir

74540 Alby sur

Cheran-France

Epiduo Gel

Gel

Each Gel Contains.

Adapalene……………0.1

%

Benzoyl Peroxide……

2.5%

(Not Mentioned)

Form-5A

Dy. No: 132

dated 01-12-

2014

50,000/-

15gm/

Rs.1500/-

Decision: Registration Board deferred case due to paucity of time.

Minutes for 253rd


Case No. 03: Grant of registration to New Drug Manufacturing Licenses / Sections

S/N Name and address

of manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

International

status in

reference drug

agencies /

authorities

Me-too status

GMP status as

depicted in

latest

inspection

report (with

date) by the

Evaluator

Remarks

EVALUATOR-I

Tablet (General)

47. M/s Iceberg

Pharmaceuticals

(Pvt) Ltd, Plot #

144, Nowshera

Industrial Estate,

Risalpur, KPK

Tablet (General)

approved in 241st

meeting of Central

Licensing Board

held on 15-05-

2015.

Pantberg Tablet

Each enteric coated

tablet contains

Pantoperazole Sodium

as sesquihydrate 40mg

Proton Pump Inhibitor

Manufacturer‟s

Specifications

Form-5

17-06-2015

diary No 224.

Rs20,000

As per SRO/

Blister of 10‟s

and 14‟s Pack

Pantoperazole

40 mg gastro

resistant tablet

by M/s

Wockhardt UK

Ltd

Abrazol tablet

by M/s Sapient

Approved.

48. -do- Bixin Tablet


Piroxicam beta

Cyclodextrin eq to

Piroxicam….. 20mg

NSAIDs

Manufacturer‟s

specifications

Form-5

17-06-2015

diary No 222.

Rs20,000

As per SRO/

Blister of 2x10

tablets Pack

Albocam by M/s

Albro

Approved with

the change of

name.

49. -do- Icepram Tablet


contains Escitalopram

as Oxalate eq to

Escitalopram… 10mg

SSRIs

USP specifications

Form-5

17-06-2015

diary No 221.

Rs20,000

As per SRO/

1x10‟s & 1x14‟s

tablets Pack

BNF. Cipralex

f/c,

Escitalopram (as

oxalate) 10 mg

Ciproxin by M/s

Bayer

Approved with

the change of

name.

50. -do- Cipberg Tablet


contains Ciprofloxacin

HCl eq to

Ciprofloxacin….

500mg

Form-5

05-06-2015

diary No 206.

Rs20,000

As per

SRO/1x10‟s

BNF.

Ciprofloxacin

(as

hydrochloride)

500 mg,

Ciproxin 500mg

Approved with

the change of

name.

Minutes for 253rd


Quinolone

USP Specifications

tablets blister

Pack

Bayer

51. -do- Icedol Tablet


Paracetamol ….500mg

Caffeine…65mg

Chlorpheniramine

Maleate….2mg

500mg

Analgesic

Manufacturer‟s

specifications

Form-5

05-06-2015

diary No 209.

Rs20,000

As per SRO/10x

10‟s & 10x20

tablets blister

Pack

Amidol by M/s

Bloom Pharma

Defered for the

confirmation of

approval by

reference

regulatory

authorities.

52. -do- Cipberg Tablet


contains Ciprofloxacin

HCl eq to ciprofloxacin

250mg

Quinolone

USP Specifications

Form-5

05-06-2015

diary No 216.

Rs20,000

As per SRO/

10‟s tablets

Pack

BNF.

Ciprofloxacin

(as

hydrochloride)

250mg,

Ciproxin by M/s

Bayer

Approved with

the change of

name.

53. -do- Moxib Tablet


contains Moxifloxacin

HCl eq to

Moxifloxacin 400mg

Floroquinolone

Manufacturer‟s

specifications

Form-5

05-06-2015

diary No 207.

Rs20,000

As per SRO/

1x5‟s tablets

blister Pack

BNF.Avelox

Tablets, f/c,

Moxifloxacin

(as

hydrochloride)

400 mg,

Moxiflox by

M/s Scottman

Approved.

54. -do- Levberg Tablet


contains Levofloxacin

Hemihydrate eq to

Levofloxacin 250mg

Quinolone

Manufacturer‟s

specifications

Form-5

17-06-2015

diary No 231.

Rs20,000

As per SRO/

1x10‟s tablets

blister Pack

BNF.Tavanic

Tablets, f/c,

Levofloxacin

250 mg,

Leflox by M/s

Getz Pharma

Approved with

the change of

name.

55. -do- Desoberg Tablet


contains Desloratadine

5mg

Antiallergic,

antihistamine

Manufacturer‟s

specifications

Form-5

17-06-2015

diary No 219.

Rs20,000

As per SRO/

10‟s tablets

blister Pack

Dailymed.

Clarinex Each

f/c tablet

contains

desloratidine

5mg

Alenor tablet by

M/s Macter

Approved with

the change of

name.

56. -do- Paxetin Tablet


contains Paroxetine

Form-5

17-06-2015

diary No 232.

BNF.Paroxetine

Tablets,

paroxetine (as

Minutes for 253rd


HCl eq to Paroxetine

20mg

SSRIs

Manufacturer‟s

specifications

Rs20,000

As per SRO/

1x10‟s tablets

blister Pack

hydrochloride)

20 mg, Seroxat

Tablets, f/c,

paroxetine (as

hydrochloride)

20 mg,

Paraxyl tablet

by M/s CCL

Approved.

57. -do- Levberg Tablet

Each film coated

Tablet contains

Levofloxacin

Hemihydrate eq to

Levofloxacin…

500mg.

Quinolone

Manufacturer‟s

Specifications

Form-5

17-06-2015

diary No 229.

Rs20,000

As per SRO/

1x10 tablet

blister pack.

BNF.Tavanic

Tablets, f/c,

Levofloxacin

500 mg,

Leflox by M/s

Getz Pharma

Approved with

the change of

name.

58. -do- Fexoberg Tablet

Each film coated

Tablet contains

Fexofenadine HCl eq

to Fexofenadine

120mg.

Antiellergic

Manufacturer‟s

Specifications

Form-5

17-06-2015

diary No 223.

Rs20,000

As per SRO/

1x10 tablet

blister pack.

Fexofenadine

HCl 120mg by

M/s Dr Reddy‟s

Laboratories UK

Aloc tablet by

M/s Bosch

Defered as the

firm has applied

for more than 10

products per

section.

Capsule General Sections

59. M/s Iceberg

Pharmaceuticals

(Pvt) Ltd, Plot #

144, Nowshera

Industrial Estate,

Risalpur, KPK

Capsule (General)

approved in 241st

meeting of Central

Licensing Board

held on 15-05-

2015.

Dicloberg Capsule

Each capsule contains

Diclofenac Sodium

enteric coated pellets

eq to Diclofenac

Sodium… 100mg

NSAID

B.P specifications

Form-5

17-06-2015

diary No 239.

Rs20,000

As per SRO/

2x10‟s & 3x10

capsules blister

Pack

------------

Dicloyan-S

capsules by M/s

Roryan, Pharma

Defered for the

confirmation of

approval by

reference

regulatory

authorities.

60. -do- Zithberg Capsule


Azithromycin as

Dihydrate 250mg

Macrolide

USP specifications

Form-5

05-06-2015

diary No 212.

Rs20,000

As per SRO/

1x6‟s & 1x10

capsules blister

Pack

Zithromax

capsule 250mg

by M/s Pfizer

UK

Acim capsule

250mg by M/s

Fynk Pharma

Approved with

the change of

name.

Minutes for 253rd


61. -do- Riseberg Capsule


Omeprazole as enteric

coated pellets eq to

Omeprazole.. 20 mg

Proton pump inhibitor

USP specifications

Source of Pellets M/s

Vision Pharma

Islamabad

Form-5

05-06-2015

diary No 213.

Rs20,000

As per SRO/

1x10‟s & 1x14

capsules blister

Pack

Losec capsule

20mg by M/s

AstraZeneca UK

Omega 20mg

capsule by M/s

Ferozsons

Approved with

the change of

name.

62. -do- Essoberg Capsule


Esomeprazole

magnesium trihydrate

pellets eq to

Esomeprazole 20 mg


Manufacturer‟s

specifications


Vision Pharma

Islamabad

Form-5

05-06-2015

diary No 218.

Rs20,000

As per SRO/

1x10‟s & 1x14

capsules blister

Pack

Emozul capsule

20mg by M/s

Consilient

Health UK

Esso 20mg

(shaigan)

Approved with

the change of

name.

63. -do- Essoberg Capsule


Esomeprazole

magnesium trihydrate

pellets eq to

Esomeprazole 40 mg


Manufacturer‟s

specifications


Vision Pharma

Islamabad

Form-5

05-06-2015

diary No 214.

Rs20,000

As per SRO/

1x10‟s & 1x14

capsules blister

Pack

Emozul 40 mg

capsule by M/s

Consilient UK

Esso 40mg

(shaigan)

Approved with

the change of

name.

Capsule Cephalosporin Sections

64. M/s Iceberg

Pharmaceuticals

(Pvt) Ltd, Plot #

144, Nowshera

Industrial Estate,

Risalpur, KPK

Capsule

(Cephalosporin)

approved in 241st

meeting of Central

Licensing Board

held on 15-05-

2015.

Icesif Capsule


Cephradine 500 mg

Cephalosporin

USP specifications

Form-5

17-06-2015

diary No 226.

Rs20,000

As per SRO/

2x6 capsules

blister Pack

Cefradine

500mg capsule

by M/s Kent

Pharmaceuticals

UK

Aksosef capsule

500mg by M/s

Akson Pharma.

Approved with

the change of

name.

65. -do- Icexib Capsule


Form-5

17-06-2015

Celebrex

capsule 200mg

Approved with

the change of

Minutes for 253rd


Celecoxib 200 mg

NSAID

Manufacturer‟s

specifications

diary No 220.

Rs20,000

As per SRO/

1x10‟s & 2x10

capsules blister

Pack

by M/s Pfizer

UK

Cobix 200mg

capsule by M/s

EG Pharma

name.

66. -do- Cxime Capsule


Cefixime trihydrate

400 mg

NSAID

USP Specifications

Form-5

05-06-2015

diary No 205.

Rs20,000

As per SRO/

1x5 capsules

blister Pack

FDA.Suprax

capsule 400mg

Avecol capsule

400mg by M/s

Aventek

Approved with

the change of

name.

Oral Dry Powder Suspension (Cephalosporin)

67. M/s Iceberg Pharmaceuticals

(Pvt) Ltd, Risalpur, KPK

Oral Dry Powder Suspension

(Cephalosporin) approved in

241st meeting of Central

Licensing Board held on 15-

05-2015

Icesif Dry

Suspension

Each 5ml contains

Cephradine

125mg

Cephalosporin

USP

Specifications

Form-5

17-06-2015 diary

No 228.

Rs20,000

As per SRO/ 60ml

glass bottle.

FDA Velosef

125mg/5ml

Alosef

125mg/5ml by

M/s Aventek

Approved with

the change of

name.

68. -do- Icesif Dry

Suspension

Each 5ml contains

Cephradine

250mg

Cephalosporin

USP

Specifications

Form-5

17-06-2015 diary

No 228.

Rs20,000

As per SRO/ 60ml

glass bottle.

FDA Velosef

250mg/5ml

Alosef

250mg/5ml by

M/s Aventek

Approved with

the change of

name.

69. -do- Cxime Dry

Suspension

Each 5ml contains

Cefixime

Trihydrate

100mg

Cephalosporin

USP

Specifications

Form-5

05-06-2015 diary

No 216.

Rs20,000

As per SRO/ 30ml

glass bottle.

FDA Cefixime

100mg/5ml by

M/s Aurobindo

pharma

Avecol

100mg/5ml by

M/s Aventek

Approved with

the change of

name.

Oral Dry Powder Suspension (General)

70. Oral Dry Powder

Suspension (general)

approved in 241st meeting

of Central Licensing Board

Cipberg Dry

Suspension

Each 5ml contains

Ciprofloxacin

Form-5

05-06-2015 diary

No 217.

Rs20,000

FDA Cipro

250mg/5ml

Ciprin 250mg/5ml

by M/s Werrick

Approved with

the change of

name

(Master

Minutes for 253rd


held on 15-05-2015 HCl 250mg

Quinolone

USP

Specifications

As per SRO/ size

not provided glass

bottle.

formulation

should be as per

decision of Board

in its 250th

meeting).

71. -do- Cipberg Dry

Suspension

Each 5ml contains

Ciprofloxacin

HCl 125mg

Quinolone

USP

Specifications

Form-5

05-06-2015 diary

No 215.

Rs20,000

As per SRO/ 60ml

glass bottle.

Ciprin 125mg/5ml

by M/s Werrick

Rejected as per

decision of

Registration

Board in its 250th

meeting.

72. -do- Zithberg Dry

Suspension

Each 5ml contains

Azithromycin

Dihydrate eq to

azithromycin

200mg

Macrolide

USP

Specifications

Form-5

05-06-2015 diary

No 211.

Rs20,000

As per SRO/ 15ml

glass bottle.

FDA

Azithromycin

200mg/5ml by

M/s Pliva

Azure

200mg/5ml, by

M/s Fynk

Approved with

the change of

name.

Evaluator I

Tablet (General)

73. M/s Zeta

Pharmaceuticals, 494-A,

Sundar Industrial Estate,

Raiwind Road, Lahore.

Tablet (General)


of Central Licensing

Board held on 15-05-

2015.

Zetamol Tablet

Each tablet

contains

paracetamol….45

0mg

Orphenadrine

Citrate….35mg

Antirheumatic/ant

i-inflammatory

Form-5

28-07-2015 diary

No 4648.

Rs20,000

Rs. 426/10x10

tablets

Require to be

verified.

Finegesic Tablet

by M/s

Mediceena

New section

Deferred as the

formulation is

under review.

74. -do- Propazet Tablet

Each enteric

coated tablet

contains

Pantoperazole

Sodium

sesquihydrate eq

to

pantoperazole….4

0mg

Manufacturer‟s

specifications

Form-5

28-07-2015 diary

No 4641.

Rs20,000

Rs. 688.10/02x07

tablets

MHRA

Pantoperazole

40mg gastro

resistant tablet by

M/s Wockhardt

Losec Tablet by

M/s Barret

New section

Approved

75. -do- Levozet Tablet

250

Each film coated

Form-5

28-07-2015 diary

No 4638.

FDA Levaquin by

Janssen Pharma

Tavanic Tablet by

Minutes for 253rd


tablet contains

Levofloxacine

Hemihydrate eq

to

Levofloxacine.….

250mg

Fluroquinolone

Manufacturer‟s

specifications

Rs20,000

Rs. 545/10

tablets

M/s Sanofi

New section

Approved

76. -do- Levozet Tablet

500

Each film coated

tablet contains

Levofloxacine

Hehihydrate eq to

Levofloxacine.….

500mg

Fluroquinolone

Manufacturer‟s

specifications

Form-5

28-07-2015 diary

No 4637.

Rs20,000

Rs. 1095/10

tablets

FDA Levaquin by

Janssen Pharma

cravit Tablet by

M/s Hilton

New section

Approved

77. -do- Zeta-Relax Tablet

Each tablet

contains

Piroxicam beta

Cyclodextrin….2

0mg

Tizinidine

HCl…2mg

Antirheumatic/ant

i-inflammatory

Form-5

28-07-2015 diary

No 4639.

Rs20,000

Rs. 513/2x10

tablets

Require to be

verified.

Abxicam 20mg

Tablet by M/s

Innvotek

New section

Deferred for

confirmation of

approval by

reference

regulatory

authority and

finished product

specifications.

78. -do- Zetaluhast Tablet

Each tablet

contains

Montelukast

Sodium….5mg

Citrizine

2HCl..10mg

Antiasthmatic/anti

allergic

Form-5

28-07-2015 diary

No 4636.

Rs20,000

Rs. 1285.36/2x7

tablets

Require to be

verified.

Require to be

verified

New section

Deferred for

confirmation of

approval by

reference

regulatory

authority and

finished product

specifications.

79. -do- Zeta Fenac-K

Tablet

Each film coated

tablet contains

Diclofenac

Potassium….50m

g

Antirheumatic

USP

Specifications

Form-5

28-07-2015 diary

No 4635.

Rs20,000

Rs. 160.66/2x10

tablets

FDA. Cataflam by

M/s Novartis

Cataflam Tablet

by M/s Novartis

New section

Approved

80. -do- Ciprozet Tablet

250

Each film coated

tablet contains

Ciprofloxacine

Form-5

28-07-2015 diary

No 4634.

Rs20,000

Rs. 286/10

FDA. Cipro 250

by Bayer

Ciproxin Tablet

by M/s Bayer

New section

Approved

Minutes for 253rd


HCl eq to

ciprofloxacine.….

250mg

Fluroquinolone

USP

specifications

tablets

81. -do- Ciprozet Tablet

500

Each film coated

tablet contains

Ciprofloxacine

HCl eq to

ciprofloxacine….

500mg

Fluroquinolone

USP

Specifications

Form-5

28-07-2015 diary

No 4640.

Rs20,000

Rs. 504.60/10

tablets

FDA. Cipro 250

by Bayer

Ciproxin Tablet

by M/s Bayer

New section

Approved

82. -do- Zetamox Tablet

Each film coated

tablet contains

Moxifloxacin HCl

eq to

Moxifloxacine….

400mg

Fluroquinolone

Manufacturer‟s

specifications

Form-5

28-07-2015 diary

No 4632.

Rs20,000

Rs. 475/10

tablets

FDA. Avelox

400mg by M/s

Bayer

Avelox Tablet by

M/s Bayer

New section

Approved

Capsule (General)

83. M/s Zeta Pharmaceuticals,

494-A, Sundar Industrial

Estate, Raiwind Road,

Lahore.

Capsule (General)


of Central Licensing Board

held on 15-05-2015.

Zetaprazole

Capsule 40mg

Each capsule

contains

omeprazole as

enteric coated

pellets eq to

omeprazole…..40

mg

PPI

Manufacturer,s

Specifications.

Source of pellets

M/s Ravoos

Laboratories, Ltd

sy. Nos.542, 543

& 544 Chivemla

(V&M),

Nalgonda District,

Telangana State,

India.

Form-5

28-07-2015 diary

No 4630.

Rs20,000 &

80,000

Rs. 688.10/2x7

tablets

FDA Omeprazole

40mg by M/s

Impex Labs

Omega Capsule

by M/s Ferozsons

New section

Approved. Firm

will submit

stability data and

legalized GMP of

pellet‟s

manufacturer and

Chairman

Registration

Board will permit

issuance of

registration letter.

84. -do- Zetaprazole

Capsule 20mg

Each capsule

contains

omeprazole as

enteric coated

pellets eq to

Form-5

28-07-2015 diary

No 4630.

Rs20,000 &

80,000

Rs. 295/2x7

tablets

FDA Omeprazole

20mg by M/s

Impex Labs

Omega Capsule

by M/s Ferozsons

New section

Approved. Firm

will submit

stability data and

legalized GMP of

pellet‟s

manufacturer and

Chairman

Minutes for 253rd


omeprazole.20mg

PPI

Manufacturer,s

Specifications.

Source of pellets

M/s Ravoos

Laboratories, Ltd

sy. Nos.542, 543

& 544 Chivemla

(V&M),

Nalgonda District,

Telangana State,

India.

Registration

Board will permit

issuance of


85. -do- Esozet Capsule

20mg

Each capsule

contains

Esomeprazole

magnesium

trihydrate as

enteric coated

pellets eq to

Esomeprazole…..

20mg

Domperidone

…5mg

PPI/antiemetic

Manufacturer,s

Specifications.

Source of pellets

of esomeprazole

M/s Ravoos

Laboratories, Ltd

sy. Nos.542, 543

& 544 Chivemla

(V&M),

Nalgonda District,

Telangana State,

India.

Form-5

28-07-2015 diary

No 4633.

Rs20,000 &

80,000

As per SRO

FDA. Nexium

20mg by M/s

Astrazeneca

Esso 20mg by

M/s Shaigan

New section

Deffered for the

confirmation of

International

availability.

86. -do- Esozet Capsule

40mg

Each capsule

contains

Esomeprazole

magnesium

trihydrate as

enteric coated

pellets eq to

Esomeprazole…..

40mg

Domperidone

…5mg

PPI/antiemetic

Form-5

28-07-2015 diary

No 4629.

Rs20,000 &

80,000

As per SRO

FDA. Nexium

20mg by M/s

Astrazeneca

Esso 20mg by

M/s Shaigan

New section

Deferred for

confirmation of

approval by

reference

regulatory

authority.

Minutes for 253rd


Manufacturer,s

Specifications.

Source of pellets

of esomeprazole

M/s Ravoos

Laboratories, Ltd

sy. Nos.542, 543

& 544 Chivemla

(V&M),

Nalgonda District,

Telangana State,

India.

87. -do- Fluconazet

Capsule 150mg

Each capsule

contains

Fluconazole…..15

0mg

Antifungal

USP

specifications

Form-5

28-07-2015 diary

No 4642.

Rs20,000

Rs.442.06/1

capsule

Diflucan 150mg

by M/s Pfizer.

Diflucan by M/s

Pfizer.

New section

Approved

88. -do- Diclozet SR 100

Capsule

Each capsule

contains

Diclofenac

Sodium as enteric

coated pellets eq

to Diclofenac

sodium ..100mg

Antirhemautic

B.P

Specifications

Form-5

28-07-2015 diary

No 4647.

Rs20,000

Rs.340.26/3x10

capsule

Dicloyan-S

capsules by M/s

Roryan, Pharma

Deferred for

confirmation of

approval by

reference

regulatory

authority and

finished product

specifications.

89. -do- Zetadol Capsule

Each capsule

contains

Tramadol

HCl…..50mg

Opoid analgesic

synthetic

Manufacturer‟s

specifications

Form-5

28-07-2015 diary

No 4644.

Rs20,000

Rs.303.16/3x1

capsule

MHRA Tramadol

50mg capsule by

M/s Aurobindo

Tremomed by

M/s Medicraft.

New section

Approved

90. -do- Zetamycin

Capsule

Each capsule

contains

Azithromycin as

dehydrate eq to

azithromycin

…..250mg

Macrolide

Manufacturer‟s

Specifications

Form-5

28-07-2015 diary

No 4645.

Rs20,000

Rs.320/10 capsule

FDA Zithromax

250mg by Pfizer.

Azethocin by M/s

BexPharma.

New section

Approved

91. -do- Klarithrozet Form-5

Minutes for 253rd


Capsule

Each capsule

contains

Clarithromycin as

dihydrate eq to

Clarithromycin….

.250mg

Macrolide

Manufacturer

Specifications

28-07-2015 diary

No 4646.

Rs20,000

Rs.358.61/10

capsule

Klaricid by M/s

Abbott.

New section

Approved

96. -do- Lansozet Capsule

Each capsule

contains

Lansoperazole as

enteric coated

pellets eq to

Lansoperazole…

…30mg

PPI

Manufacturer‟s

specifications

Form-5

28-07-2015 diary

No 4643.

Rs20,000

Rs.378/2x7

capsule

MHRA

Lansoperazole 30

mg gastro

resistant capsules.

Lanzac by M/s

Don Valley.

New section

Approved

Evaluator IV

Deferred cases of 251st meeting

97. M/s Mafins Pharma, A-5,

S.I.T.E, Super Highway

Industrial Area, Karachi

Tablet (General)




2015.

Tablet Ciflox 250

mg

Each film coated

tablet contains

Ciprofloxacin (as

HCl.H2O) U.S.P

eq. to

Ciprofloxacin 250

mg

Quinolone Group

of Antibiotics

(USP

Specification)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 305

Pack of

10‟s / Rs. 354

20‟s / Rs. 680

100‟s / Rs 2860

FDA approved

tablet Cipro 250

mg

Tablet Ciprin 250

mg (Werrick)

New License

Approved

98. -do- Ciflox Tablet 500

mg

Each film coated

tablet contains:

Ciprofloxacin [as

HCl.H2O] (USP

Spec) eq to

Ciprofloxacin 500

mg

Quinolone

Antibiotics

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 303

Pack of

10‟s/Rs.623

20‟s / Rs. 1246

100‟s / Rs. 6230

FDA approved

Tablet Cipro 500

mg manufactured

by BAYER

HEALTHCARE

Tablet Ciprin 500

mg by Werrick

Approved

99. -do- Tablet D-Fenac

50 mg

Each enteric

coated tablet

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 296

Pack of

FDA approved

Diclofenac

Sodium Tablet 50

mg manufactured

by ACTAVIS

Approved

Minutes for 253rd


contains

Diclofenac

Sodium 50 mg

(USP

specification)

Phenylacetic acid

10‟s / Rs. 45

20‟s / Rs 210

30‟s / Rs. 269

100‟s / Rs. 875

200‟s / Rs. 910

300‟s / Rs. 980

500‟s / Rs 1020

ELIZABETH

Tablet Mobikare

50 mg (Barrett

Hodgson)

100. -do- Mecob Tablet 500

mcg

Each Sugar

Coated Tablet

contains:

Mecobalamin J.P

500 mcg

Vitamin B12 co -

enzyme

(Manufacture

Spec.s)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 293

Pack of

20‟s / Rs. 573

30‟s / Rs. 655

100‟s / Rs. 940

------

Elgin Tablet 500

mcg (Novartis)

Approved

101. -do- Tablet Levox 250

mg

Each film coated

tablet contain

Levofloxacin (as

hemihydrate) USP

eq to

Levofloxacin 250

mg

(USP

specification)

Quinolone group

of antibiotics

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 302

Pack of

10‟s / Rs. 545

14‟s / Rs. 680

100‟s / Rs 1656

FDA Pfiziflox

tablet 250 mg

Tablet Leflox

250 mg (Getz)

Approved

102. -do- Tablet Levox 500

mg

Each film coated

tablet contain

Levofloxacin (as

hemihydrate) USP

eq to

Levofloxacin 500

mg

(USP

Specification)

Quinolone group

of antibiotics

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 298

Pack of

10‟s / Rs. 1095

14‟s / Rs. 1320

100‟s / Rs 1820

FDA Pfiziflox

500 mg tablet

Tablet Leflox

500 mg (Getz)

Approved

103. -do- Tablet Meflam 75

mg

Each sugar coated

Form 5

Rs. 20,000/-

(09-06-2015)

Tablet Artimov-

K 75 mg (Hilton)

Deferred for

confirmation of

approval by

reference

Minutes for 253rd


tablet contains

Diclofenac

Potassium 75 mg

(USP

specification)

Phenylacetic acid

Dy. No. 278

Pack of

10‟s / Rs. 45

20‟s / Rs. 160

30‟s / Rs 195

100‟s / Rs. 800

200‟s / Rs. 1620

regulatory

authority and

finished product

specifications.

The Board further

decided to review

all the locally

registered

products in the

same strength and

dosage form

104. -do- Tablet Tenor 50

mg

Each film coated

tablet contain

Atenolol 50 mg

(USP

specification)

Beta Blocking

Agent,

Cardioselective

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 306

Pack of

10‟s / Rs. 37

14‟s / Rs. 85

20‟s / Rs. 100

30‟s / Rs 180

100‟s / Rs 485

FDA Tenormin

tablet 50 mg

Tablet Zafnol 50

mg (Zafa)

Approved

105. -do- Tablet Profen 100

mg

Each film coated

tablet contain

Flurbiprofen USP

100 mg

Propionic acid

(USP

specification)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 295

Pack of

10‟s / Rs. 75

20‟s / Rs 140

30‟s / Rs. 210

100‟s / Rs. 785

FDA Ansaid 100

mg Tablet

Tablet Vobifen

100 mg (Novartis)

Approved

106. -do- Tablet Fammo 40

mg

Each film coated

tablet contains

Famotidine 40

mg

(USP

specification)

Anti ulcer

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 301

Pack of

10‟s / Rs. 325

20‟s / Rs 428

30‟s / Rs. 690

100‟s / Rs. 976

FDA Pepcid 40

mg Tablet

Tablet Ulfam 40

mg (High Noon)

Approved




Capsule (General)


Indosone Capsule

25 mg

Each Capsule

contains:

Indomethcin 25

mg

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 282

Pack of

100‟s / Rs. 96

500‟s / Rs. 294

FDA Indocin

25mg

Capsule Epomet

25 mg (Epoch

International)

Approved

Minutes for 253rd




2015.

NSAID

(USP Spec.s)

1000‟s / Rs. 589 New License

108. -do- Azzi Capsule 250

mg

Each Capsule

contains:

Azithromycin [as

Dihydrate] USP

262 mg eq to

Azithromycin 250

mg

Macrolide

Antiobiotic

(USP Spec‟s)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 288

Pack of

3‟s / Rs. 150

6‟s / Rs. 255

10‟s / Rs. 320

12‟s / Rs. 398

FDA Capsule

Zithromax 250

mg

Capsule Zetro 250

mg (Getz)

Approved

109. -do- Meso Capsule 40

mg

Each Capsule

contains:

Esomeprazole as

[magnesium

trihydrate] USP

enteric coated

pellets eq (22.5%)

to esomeprazole

40mg

Proton Pump

Inhibitor

(Manufacturer

Spec.s)

Source of pellets

M/s Qualitek

Pharma Plot #115,

Jeedimetla

Industrial Ara,

Phase V, Extn.

Doolapally

Village,

Quthbullapur

Mandal,

Hyderabad.

Form 5

Rs. 20,000/- +

80,000/-

(09-06-2015)

Dy. No. 290

Pack of

14‟s / Rs. 323

10‟s / Rs. 230

20‟s / Rs. 461

100‟s / Rs 2300

FDA Capsule

Nexium 40 mg

Esso 40 Capsule

(Shaigan)

Approved. Firm

will submit

stability data and

legalized GMP of

pellet‟s

manufacturer and

Chairman

Registration

Board will permit

issuance of


110. -do- Meso Capsule 20

mg

Each Capsule

contains:

Esomeprazole as

[magnesium

trihydrate] enteric

Form 5

Rs. 20,000/- +

80,000/-

(09-06-2015)

Dy. No. 289

Pack of

FDA Capsule

Nexium 20 mg

Esso 20 Capsule

(Shaigan)

Approved. Firm

will submit

stability data and

legalized GMP of

pellet‟s

manufacturer and

Chairman

Registration

Minutes for 253rd


coated pellets

(22.5%) eq to

esomeprazole 20

mg

Proton Pump

Inhibitor

(Manufacturer

Spec.s)

Source of pellets

M/s Qualitek

Pharma Plot #115,

Jeedimetla

Industrial Ara,

Phase V, Extn.

Doolapally

Village,

Quthbullapur

Mandal,

Hyderabad.

14‟s / Rs.170

10‟s / Rs. 121

20‟s / Rs. 437

100‟s / Rs 2185

Board will permit

issuance of


111. -do- Rissem Capsule

20 mg

Each Capsule

contains:

Omeprazole as

enteric coated

pellets 8.5% USP

eq to omeprazole

20mg

Proton Pump

Inhibitor

(Manufacturer

Spec.s)

Source of pellets

M/s Ravoos

Laboratories Ltd,

situated at Sy. No.

542,543 & 544,

Chivemla (V &

M), Nalgonda

District,

Telangana, India

Form 5

Rs. 20,000/- +

80,000/-

(09-06-2015)

Dy. No. 291

Pack of

10‟s / Rs.350

14‟s / Rs. 688

20‟s / Rs. 705

28‟s / Rs 765

30s‟s / Rs. 825

100‟s / Rs. 918

FDA Capsule

Lozal 20 mg

Risek 20 mg

Capsule (Getz)

Approved. Firm

will submit

stability data and

legalized GMP of

pellet‟s

manufacturer and

Chairman

Registration

Board will permit

issuance of


112. -do- Rissem Capsule

40 mg

Each Capsule

contains:

enteric coated

pellets of

Omeprazole eq to

omeprazole 40mg

(Manufacturer

Spec.s)

Form 5

Rs. 20,000/- +

80,000/-

(09-06-2015)

Dy. No. 292

Pack of

10‟s / Rs.900

14‟s / Rs. 1643

20‟s / Rs. 1875

100‟s / Rs. 2500

FDA Capsule

Lozal 40 mg

Risek 40 mg

Capsule (Getz)

Approved. Firm

will submit

stability data and

legalized GMP of

pellet‟s

manufacturer and

Chairman

Registration

Board will permit

issuance of


Minutes for 253rd


Proton Pump

Inhibitor

Source of pellets

Qualtek Pharma,

Plot # 115,

Jeedimetla

Industrial Area,

Phase V, Extn.

Doolapally

Village,

Quthbullapur

Mandal,

Hyderabad. India

113. -do- Doxyclin Capsule

100 mg

Each Capsule

contains:

Doxycyclin

Hyclate USP 115

mg eq to

Doxycycline 100

mg

Antibiotic

Tetracyclin

(USP Spec‟s)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 304

Pack of

10‟s / Rs. 60/-

14‟s / Rs. 77/-

20‟s / Rs. 60/-

30‟s / Rs, 190

50‟s / Rs. 250

60‟s / Rs 381

80‟s / Rs 389

100‟s / Rs. 636

120‟s / Rs. 763

200‟s /Rs. 1270

1000‟s / Rs. 1820

FDA Capsule

Wellcodox (GSK)

Capsule Megadox

(Hilton)

Approved

114. -do- Transa Capsule

500 mg

Each Capsule

contains:

Tranexamic Acid

500 mg

Haemostatic /

Fibrinolytic

(JP Spec.s)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 300

Pack of

10‟s / Rs. 125/-

20‟s / Rs. 330/-

30‟s / Rs, 431

50‟s / Rs. 780

100‟s / Rs. 960

Capsule

Maxma(AGP)

Approved with

the change of

name

115. -do- Linnco Capsule

500 mg

Each Capsule

contains:

Lincomycin (as

HCl) USP 544mg

eq to Lincomycin

500mg

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 294

Pack of

10‟s / Rs. 94/-

12‟s / Rs. 132

FDA Capsule

Lincocin

Capsule Linerg

(Helix)

Approved

Minutes for 253rd


Antibiotics

(USP Spec.s)

20‟s / Rs. 220/-

100‟s / Rs. 890

116. -do- Pirox Capsule 20

mg

Each Capsule

contains:

Piroxicam (U.S.P)

20 mg

NSAID/Antigout/

Antipyretic

(USP Spec‟s)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 283

Pack of

10‟s / Rs. 189/-

14‟s / Rs. 205.

20‟s / Rs. 294/-

30‟s / Rs, 360

40‟s / Rs 410

100‟s / Rs. 771

500s Rs. 3680/

FDA Capsule

Felene

Capsule

Fycam(Fynk)

Approved




Cream/Ointment/Gel

(General) approved in

241st meeting of Central

Licensing Board held on

15-05-2015.

Moltral Gel 1%

Each gm contains

Diclofenac

Diethylamine

11.6 mg eq. to

Diclofenac

Sodium 10 mg

Phenyl Acetic

Acid

(B.P

Specification)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 287

Pack of

10 gm / Rs. 49

15 gm / Rs. 78

20 gm / Rs 112

25 gm / Rs. 129

50 gm / Rs. 257

FDA

Voltarol® 1.16%

Emulgel®, gel

Mobikare Gel

(Asian

Continental)

Approved

118. -do- Clotrim Cream

1%

Each gm contains

Clotrimazole 10

mg

Imidazole / Anti

fungal

(USP Spec‟s)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 279

Pack of

5 gm / Rs. 30

10 gm / Rs. 57

15 gm / Rs. 46

20 gm / Rs 98

35 gm / Rs. 105

FDA Canesten

Topical

Stimazole (GSK)

Approved

119. -do- Pirox Gel 0.5%

Each gm contains

Piroxicam 5 mg

(BP)

BP Specifications

NSAID ,Oxicam

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 280

Pack of

10 gm / Rs. 47

20 gm / Rs 87

25 gm / Rs. 165

MHRA approved

Feldene Gel 0.5

%

Diodex 0.5%

(Pearl)

Approved

Minutes for 253rd


120. -do- Neomyskin

Ointment 0.5%

Each gram

contains

Neomycin 5mg

equivalent to

Neomycin 3.5mg.

Aminoglycolide

Antibiotics

(USP

Specification)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 284

Pack of

5 gm / Rs. 13

13 gm / Rs. 32

15 gm / Rs. 36

20 gm / Rs 48

Approved as OTC

in USFDA

Tsomycin (Tas

Pharmaceuticals)

Approved

121. -do- Menadex – N

Cream

Each gram

contains

Dexamethasone

Phosphate 10 mg

(Dexamethasone

Sodium

Phosphate)

Neomycin 3.5 mg

(as Sulfate)

(USP

Specification)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 297

Pack of

5 gm / Rs. 19

13 gm / Rs. 40

15 gm / Rs. 35

20 gm / Rs 68

Dexamin – N

Cream

(Geoffman)

Deferred for

confirmation of

approval by

reference

regulatory

authority.

122. -do- Lignocaine

Compound

Ointment

Each Ointment

contains

Lignocaine HCl

0.5%

Ephedrine HCl

0.25%

Allantoin 0.50%

(BP Specification)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 286

Pack of

15 gm / Rs. 16

30 gm / Rs 49.88

Logel (Elite

Pharma)

New License

Deferred for

confirmation of

approval by

reference

regulatory

authority.

123. -do- Derma Cream 1%

Each Ointment

contains Silver

Sulphadiazine 1%

(USP

Specification)

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 285

Pack of

10 gm / Rs. 18

15 gm / Rs. 45

20 gm / Rs 88

25gm / Rs 83

30gm / Rs 97

FDA approved

Dermazin

manufactured by

Novartis

Sulphazin (Swiss

Pharma )

Approved

Minutes for 253rd


50 gm / Rs 220

250 gm / Rs. 617

500 gm / Rs. 900

124. -do- Beta – N Cream

Each 1 g contains

1 mg of

betamethasone

(0.1% w/w) as

valerate and 5 mg

of neomycin

sulphate (0.5%

w/w).

(USP

Specification)

Corticosteroid +

Antibiotics

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 274

Pack of

5 gm / Rs. 17

10 gm / Rs 34

15gm / Rs 38

MHRA approved

Betnovate-N

Cream (GSK)

Betaderm-N

Cream (ATCO)

Approved

125. -do- Xylo Gel 2% w/v

Each mL contains

20 mg of

lignocaine HCl

(USP

Specification)

local anesthetic

agent

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 274

Pack of

5 gm / Rs. 25

10 gm / Rs 34.5

15gm / Rs 45

30 gm / Rs. 80

TGA approved

Lignocaine Gel

2% Sterile

Lignocaine HCl

(Orion

Laboratories)

Xylocaine Gel

(Barrett Hodgson)

Registration

Board deferred

the case for

determining status

of PARAS.

126. -do- Gentacin Cream

(0.1%)

Each gram

contains

Gentamicin

Sulfate USP

equivalent to 1

mg gentamicin

base

(USP

Specification)

Aminoglycoside

Antibiotics

Form 5

Rs. 20,000/-

(09-06-2015)

Dy. No. 299

Pack of

4 gm / Rs. 9.06

10 gm / Rs 27

15gm / Rs 54

20 gm / Rs. 85

FDA approved

Gentamicin

Sulphate Cream

USP 0.1%

Xylocaine Gel

(Barrett Hodgson)

Approved

Minutes for 253rd


DDC (PEC)

(Sachet Section) approved in 240th

meeting of Central Licensing Board held on 06th

March 2015.

127. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

(Sachet Section)

Stron 2g Sachet.

Sachet

Each Sachet contains:

Strontium Ranelate…..2.0g

(Granules for oral suspension)

Antiosteoporotic

(Manufacturer’s Specs)

Form-5

Dy. No:

1002 dated

16-04-2015

20000/-

dated 15-04-

2015

As per SRO

MHRA, UK

available in the form

of granules for oral

suspension

Onita by Pharmevo

Karachi.

.

Approved

128. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Linte Sachet.

Sachet


Sodium chloride………3.5g

Sodium citrate………..2.9g

Potassium chloride……1.5g

Glucose, anhydrous….13.5g

Electrolyte replenisher,

Antidiarrhoeals


Form-5

Dy. No:

1003

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

WHO Approved Approved

129. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Strong Sachet.

Sachet


Calcium lactate

gluconate..1000mg

Vit c (ascorbic acid)….500mg

Calcium

carbonate…….327mg

Calcium supplement


Form-5

Dy. No: 997

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

International

availability is not

confirmed

Calcium pearl sachet

by Pearl

Pharmaceuticals

Deferred for

confirmation of

approval by

reference

regulatory

authority.

130. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

PNK Sachet.

Sachet


Macrogol 3350…….13.125g

Sodium Chloride…..0.3507g

Sodium

Bicarbonate……0.1785g

Potassium

Chloride……0.0466g

(Powder for oral solution)


Form-5

Dy. No:

1005

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

UK. Movicol sachet

by Norgine Limited.

NabiQasim, Hilton,

Genix

Approved

131. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Streett no.

S-5, National

Industiral Zone

Rawat Islamabad.

Airmax Sachet.

Sachet

Each Sachet of granules

contains:

Montelukast sodium

equivalent to

montelukast……4mg

Leukotriene receptor

Form-5

Dy. No: 998

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

SINGULAIR®

Paediatric sachet by

Merck Sharp &

Dohme Limited

Aerokast by Barret

Hodgson

Deferred for:

Complete

description of the

product /

pharmaceutical

form.

Correction of

manufacturing

Minutes for 253rd


antagonist (LTRA)


method as FPP in

the form of

granules whereas

the manufacturing

process lacks

granulation as a

part of

manufacturing

process.

132. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Streett no.

S-5, National

Industiral Zone

Rawat Islamabad.

Ospra Sachet.

Sachet


Omeprazole……40mg

Sodium

bicarbonate……1680mg

Anti-ulcerants (Proton Pump

Inhibitors)

(Powder for oral suspension)


Form-5

Dy. No:

1000

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in FDA,

Zegerid sachet by

Santarus INC

Risek by Getz

Pharma.

Deferred as

product is under

review.

133. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

RSNK Sachet.

Sachet


Pre-cooked Rice

Powder……6.0g

Sodium Citrate……..0.580g

Sodium Chloride…….0.350g

Potassium

Chloride……0.300g

Antidiarrhoeals (Rehydration

Fluids)

(Sachet containing powder for

mixing with water prior to

administration).


Form-5

Dy. No:

1004

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

Dioralyte

Relief sachet by M/s

Sanofi, UK.

Dioralyte Rice of

M/s Sanofi, Karachi.

Approved

134. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

ISMEB Sachet.

Sachet

Each Sachet of granules

contains:

Mebeverine hydrochloride B.P

….135mg

Ispaghula husk B.P……3.5g

(Granules for oral suspension)

Irritable bowel syndrome

(Laxative)


Form-5

Dy. No:

1002

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

Fybogel Mebeverine

of Forum Health

Products Limited

Husk-M of Genix

Karachi.

Deferred for:

Complete

description of the

product /

pharmaceutical

form.

Correction of

manufacturing

method as FPP in

the form of

granules whereas

the manufacturing

process lacks

granulation as a

part of

manufacturing

process.

Minutes for 253rd


135. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Zakam Sachet.

Sachet


Paracetamol……..500mg

Pseudoephedrine

Hcl……30mg

Mepyramine

Maleate……13mg

Pheniramine

maleate……13mg

Cold Preparations without

Anti-Infective.


Form-5

Dy. No: 999

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

International

availability in

reference authorities

not confirmed.

Me too not

confirmed

Deferred for

confirmation of

International

availability in

reference

authorities and

me-too status.

Change of brand

name required.

136. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Trof Sachet.

Sachet


Fosfomycin tromethamine

equivalent to

fosfomycin….3.0g

Antibiotec


Form-5

Dy. No:

1001

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Munorol, USFDA.

Monurol by Scharper

Pharmaceutical Pvt

Ltd.

Approved

Cream/Ointment/Gel (General) approved in 240th

meeting of CLB dated 06-03-2015

137. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

(Ointment section)

Fude Ointment 2.0%

Ointment

Each gram contains:

Sodium fusidate……20mg

(2%)

Antibiotec (Topical

antibacterials)

(B.P Specs)

Form-5

Dy. No:

1009

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

UK. Fusidin of Leo

labs UK.

Fusac by Sante Pvt

Ltd

Approved

138. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Voltag Gel 1.0%

Gel

Each gram of gel contains:

Diclofenac Diethylamine

equivalent to diclofenac Na

B.P ….10mg (1.0%)

Non-Steroidal Anti-

Inflammatory Drug

(B.P Specs)

Form-5

Dy. No:

1011

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

UK. Voltral emugel

of M/s Novartis UK.

Klic by Tabros

pharma

Approved with

change of brand

name.

139. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

La‟Pain Gel 0.5%

Gel


Piroxicam……5mg (0.5%)

Form-5

Dy. No:

1012

dated 16-04-

Available in MHRA,

UK. Feldene of M/s

Pfizer UK.

Felden of M/s Pfizer

Approved with

change of brand

name.

Minutes for 253rd


S-5, National

Industiral Zone

Rawat Islamabad.

Non-Steroidal Anti-

Inflammatory Drug

(B.P Specs)

2015

20000/-

dated 15-04-

2015

As per SRO

Karachi.

140. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Fude Cream 2.0%

Cream

Each gram of cream contains:

Fusidic acid….20mg (2.0%)

Antibiotic (Topical

antibacterials)

(B.P Specs)

Form-5

Dy. No:

1013

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

UK. Fusidin of Leo

labs UK.

Sidic of Epoch

Karachi.

Approved

141. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Nobac Cream 2.0%

Cream


Mupirocin Calcium 2H2O

equivalent to

Mupirocin…20mg/g

Antibiotic (Topical

antibacterials)

(U.S.P Specs)

Form-5

Dy. No:

1007

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

UK. Bactroban

cream of M/s GSK,

UK

Bactroban of GSK,

Karachi

Approved with

change of brand

name.

142. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Keston Cream 0.005%

Cream


Calcipotriol as

Monohydrate…. 0.05mg/g

(0.005%)

Vitamin D analogue


Form-5

Dy. No:

1010

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Discontinued by Leo

Pharma Uk.

Calcipot of Valor

Pharmaceutical

Deferred for

confirmation of

International

availability in

reference

authorities.

143. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Ketpro Gel 2.5%

Gel


Ketoprofen……25mg(2.5%)

Non-Steroidal Anti-

Inflammatory Drug

(B.P Specs)

Form-5

Dy. No:

1015

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

UK. Orovail 2.5%

Gel of M/s Sanofi

UK

Profenid of M.s

Sanofi Karachi.

Approved

144. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Acpro Gel 0.1%

Gel


Adapalene……0.1%(1mg)

Anti-acne

(B.P Specs)

Form-5

Dy. No:

1008

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

UK. Differin Gel of

M/s Galdermas UK

Mingle of Valor

Pharma

Approved

Minutes for 253rd


145. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Bina Cream 1.0%

Cream


Terbinafine as HCl …..10mg

(1.0%)

Antifungal


Form-5

Dy. No:

1014

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

Available in MHRA,

UK. Lamisil Cream

of M/s Novartis UK.

Antifun by M/s

Chas.A Mendoza

Approved

146. M/s Linta

pharmaceuticals

(Pvt) Limited Plot

No. 03, Street no.

S-5, National

Industiral Zone

Rawat Islamabad.

Clin Gel 20g

Gel


Clindamycin

Phosphate…1.2%

Tretinoin…….0.025%

Antibiotic and Retinoid

(USP Specs)

Form-5

Dy. No:

1006

dated 16-04-

2015

20000/-

dated 15-04-

2015

As per SRO

International

availability is not

confirmed.

Cleret by M/s Tabros

Pharma

Deferred for

confirmation of

approval by

reference

regulatory

authority.

DDC (PEC)

M/s Gallop Water Sciences 404, Sunder Industrial Estate Lahore.

New License (IV solution, LVP) Section

147. M/s Gallop Water

Sciences 404, Sunder

Industrial Estate

Lahore.

New License

(IV solution, LVP)

Section approved in

241st meeting of CLB

held on 15-05-2015.

G-SOL RL

IV Infusion

Each 100ml contains:

sodium

chloride……..0.60gm

Potassium

Chloride…0.04gm

Calicum Chloride2H2o

…0.27gm

Sodium lactate……0.32gm Electrolytic solution.

(B.P Specs)

Form-5

Dy. No: 3469.

dated 18-05-2015

20,000/-

Rs.77/-

Rs.56/-

Rs.50/-

1000ml, / 500ml

/200ml

Available in

MHRA, UK.

Compound

Sodium Lactate

Intravenous

Infusion of M/S

Baxter Health

ca3333333re

UK, Ltd.

.Me-too:

Hartmann‟s Sol

M/s LCPW,

Lahore

Approved.

Firm will select one

pack size as per

procedure and

Registration Board

authorized its

Chairman for

subsequent approval

for issuance of

registration letter


Sciences 404, Sundar

Industrial Estate

Lahore.

G-SOL DS

IV Infusion


Dextrose

anhydrous…..5gm

Sodium

chloride…….0.9gm

Caloric & Electrolyte

Sodium

(B.P Specs)

Form-5

Dy. No: 3463.

dated 18-05-2015

20,000/-

Rs.65/-

Rs.55/-

Rs.500

1000ml,500ml

200ml

• Available in US

FDA. dextrose 5%

and sodium

chloride 0.9% in

plastic container of

M/s Hospira, US.

(nda # 017585)

Me-too: M/s

Elko , Karachi

Approved.


pack size as per

procedure and

Registration Board

authorized its

Chairman for

subsequent approval

for issuance of

registration letter

Minutes for 253rd




Industrial Estate

Lahore.

G-SOL 5%

IV Infusion


Dextrose

anhydrous….5gm

Caloric solution

(B.P Specs)

Form-5

Dy. No: 3465.

dated 18-05-2015

20,000/-

Rs.57/- RS.55/-

Rs.50/- 1000ml,

500ml, 200ml

• Available in US

FDA. dextrose 5%

and in plastic

container of M/s

Hospira, US.

Me-too: M/s

FDL, Hattar.

Approved.


pack size as per

procedure and

Registration Board

authorized its

Chairman for

subsequent approval

for issuance of

registration letter



Industrial Estate

Lahore.

G-SOL (1/2) IV Infusion

IV Infusion


Dextrose

anhydrous……5gm

Sodium

Chloride……0.45gm Caloric & Electrolytic

solution

Form-5

Dy. No: 3467

dated 18-05-2015

20,000/-

Rs.55/500ml

Bottle

Rs.50/200ml

Bottle

• Available in US

FDA. dextrose 5%

and NaCl 0.45% in

plastic container of

M/s Hospira, US.

Me-too: M/s

Atlantic Pharma,

Ltd.

Approved.


pack size as per

procedure and

Registration Board

authorized its

Chairman for

subsequent approval

for issuance of

registration letter



Industrial Estate

Lahore.

G-SOL PAEDS

IV Infusion


Dextrose anhydrous….4.3g

Sodium

Chloride……..0.18g

Caloric & Electrolytic

solution

Form-5

Dy. No: 3472

dated 18-05-2015

20,000/-

Rs.50/- Rs.40/-

500ml, 200ml

• Int availability

not confirmed.

Me-too: Macsol

Paeds of M/s Mac

& Rains Lahore.

Deferred for

confirmation of

approval by

reference

regulatory

authority.



Industrial Estate

Lahore.

G-SOL RLD

IV Infusion


Sodium

chloride…….0.60gm

Potassium

chloride…0.03gm

Calcium

chloride2H2o..0.2gm

Sodium

lactate…….0.31gm

Dextrose …………….5gm

Electrolytic & caloric

sodium

(B.P Specs)

Form-5

Dy. No: 3455

dated 18-05-2015

20,000/-

Rs.84/- Rs.59/-

Rs.50/-

1000ml,500ml

200ml

• Available in US

FDA. M/s B Braun

, US.

Me-too:

Ringolact-D of

M/s Otsuka,

Karachi.

Approved.


pack size as per

procedure and

Registration Board

authorized its

Chairman for

subsequent approval

for issuance of

registration letter



Industrial Estate

Lahore.

G-SOL (NS)

IV Infusion


Sodium

chloride……….0.9gm

Electrolyte

(USP Specs)

Form-5

Dy. No: 3471

dated 18-05-2015

20,000/-

Rs.60/-, Rs.55/-

Rs.50/-, 1000ml,

500ml, 200ml,

• Available in US

FDA. M/s Hospira

, US.

Me-too: Lifesol

of M/s Geofman,

Karchi

Approved.


pack size as per

procedure and

Registration Board

authorized its

Chairman for

Minutes for 253rd


subsequent approval

for issuance of

registration letter



Industrial Estate

Lahore.

G-SOL 10%

IV Infusion


Dextrose

Anhydrous…..10gm

Caloric solution

(BP Specs)

Form-5

Dy. No: 3473

dated 18-05-2015

20,000/-

Rs.70/- Rs.56/-

1000ml, 500ml,

• Available in US

FDA. M/s Baxter

Healthcare, US.

Me-too: M/s

LCPW, Lahore.

Approved.


pack size as per

procedure and

Registration Board

authorized its

Chairman for

subsequent approval

for issuance of

registration letter



Industrial Estate

Lahore.

G-Lyte M

IV Infusion


Sodium

Chloride……..0.216gm

Potassium

Chloride…..1.5gm

Calcium Chloride 2 H2O

…..…0.022

Sodium Acetate 3 H2O

…0.313gm

Dextrose………..5.0gm

Electrolytic & Caloric

solution

Form-5

Dy. No: 3473

dated 18-05-2015

20,000/-

Rs.100/- Rs.70/-

1000ml, 500ml,

Internationally,

not available in

this strength.

Me-too:

Plabolyte-M of

M/s Otsuka,

Karachi

Deferred for

confirmation of

approval by

reference

regulatory

authority.



Industrial Estate

Lahore.

Mannitol

IV Infusion


Mannitol…….17.5gm

Sorbitol…….2.5gm

Osmotic diuretic

Form-5

Dy. No: 3458

dated 18-05-2015

20,000/-

Rs.200/- 500ml

Internationally

Not available in

this strength

Me-too: Mactol

of M/s Mac &

Rains, Lahore

Deferred for

confirmation of

approval by

reference

regulatory

authority.

Evaluator II

159. M/s Hi-Medic

pharmaceuticals

private limited

19- km link

multan road

Lahore

Capsule

Ceftrim Capsule 200mg


Cefixime Trihydrate eq to

Cefixime USP……. 200mg

Capsule

(Cephalosporin)

In-House Specs.

Form 5

Dy No.4846

Dated.

04-08-2015

Rs.20,000/-

Rs.313/-

10‟s

Maxophine

Capsule of M/s

Global

Pharmaceutical

Islamabad.

International

Availability not

provided.

As per Decision of RB.

In 250th meeting is:-

1. Applicants shall

either revise their

formulation to tablet

dosage form, if not

registered previously

and if manufacturing

facility is approved by

Minutes for 253rd


Cephalosporin

Section approved

in 242nd

meeting

of CLB held on

08-07-2015.

CLB (new registration

application with

complete fee) or,

2. Shall submit

Pharmaceutical

development data

including stability,

bioavailability/

bioequivalence studies

within six months

period.

3. For already registered

drugs, same procedure

as mentioned above (at

Sr. No. i & ii) shall be

adopted. Otherwise

show cause notice shall

be issued for

deregistration of drug in

this formulation.

4.All such application

shall be processed on

priority basis.

160. -Do-

Ceftrim Capsule 400mg


Cefixime Trihydrate eq to

Cefixime USP……. 400mg

Capsule

(Cephalosporin)

In-House Specs.

Form 5

Dy No.4847

Date.04-08-2015

Rs.20,000/-

Rs.512.51/-

5‟s

Cefspan Capsule

400mg by M/s

Barrett Hodgson

Pharmaceuticals.

(US-FDA)

Approved

161. -Do-

Cefrad Capsule 500 mg

Each Capsule contains

Cephradine Monohydrate eq

to Cephradine USP…

…500mg

(Cephalosporin)

Usp specs

Form 5

04-08-2015

Rs.20,000/-

12‟s /Rs.244.67/-

Velosef 250mg by

Glaxosmithkline

Pakistan.

(US-FDA)

Approved

162. -Do-

Cefrad Capsule 250 mg



to Cephradine USP…..

250mg

(Cephalosporin)

Usp specs

Form 5

04-08-2015

Rs.20,000/-

12‟s/Rs.124.55/-

Velosef 250mg per

Capsule by

Glaxosmithkline

Pakistan.

(US-FDA)

Approved

163. -Do-

Roxil Capsule 500 mg


Cefadroxil Monohydrate eq

to Cefadroxil USP…. 500

mg

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

12‟s / Rs.359.23/-

Duricef Capsule

500mg by

Glaxosmithkline

Pakistan.

MHRA

Approved

Minutes for 253rd


164. -Do-

Farox Capsule 100 mg

Each capsule contains.

Cefpodoxime Proxetil eq to

Cefpodoxime …… 100 mg

(Cephalosporin)

Inhouse specs

Form 5

04-08-2015

Rs.20,000/-

10‟s/ Rs. 300/-

Nefdoxime Capsule

100mg by

Neomedix

Islamabad.

International

availability not

provided.

As per Decision of RB

in 250th meeting is as

follow.

1.New applicants shall

either revise their

formulation to tablet

dosage form, if not

registered previously

and if manufacturing

facility is approved by

CLB (new registration

application with

complete fee) or,

2.Shall submit

Pharmaceutical

development data

including stability,

bioavailability/

bioequivalence studies

within six months

period.

3.For already registered

drugs, same procedure

as mentioned above (at

Sr. No. i & ii) shall be

adopted. Otherwise

showcause notice shall

be issued for

deregistration of drug in

this formulation.

All such application

shall be processed on

priority basis.

165. -Do-

Clocef Capsule 500 mg


Cefaclor Monohydrate eq to

Cefaclor USP…………

500mg

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

12‟s/-

Rs. 557.82/-

Ceclor Capsule

500mg by AGP

Karachi.

(US-FDA)

Approved

166. -Do-

Clocef Capsule 250 mg



Cefaclor USP…… 250mg

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

12‟s /

Rs. 304.78/-

Ceclor Capsule

250mg by AGP

Karachi.

US-FDA

Approved

Minutes for 253rd


167. -Do-

Lecef Capsule 500 mg


Cephalexin Monohydrate eq

to Cephalexin USP 500 mg

Capsule

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

12‟s/ Rs. 244.67/-

Ceporex Capsule

200mg by

Glaxosmithkline

Karachi.

(MHRA)

Approved

168. -Do-

Lecef Capsule 250 mg



to Cephalexin USP………

250mg

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

12‟s / Rs. 102/-

Ceporex Capsule

250mg by

Glaxosmithkline

Karachi.

(MHRA)

Approved

Dry Powder Injection (Cephalosporin)

169. M/s Hi-Medic

pharmaceuticals

private limited

19- km link

multan road

Lahore

Dry Powder

injection Vials

Cephalosporin

approved in 242nd

meeting of CLB

dated 08-07-2015.

Hyphin Injection 1 gm

Each vial contains:-

Ceftriaxone Sodium USP eq

to Ceftriaxone 1.0 gm

Injection (IV)

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

597/- per

pack(1‟s)

Rocephin

Injection 1gm by

Martin Dow

Pharmaceuticals-

Karachi

USFDA

Deferred for

clarification of API

(Ceftriaxone DiSodium

Pentahydrate) as

claimed by the firm

170.

-do-

Hyphin Injection 500 mg



to Ceftriaxone 500 mg

Injection (IV)

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

299/- per pack

Rocephin

Injection 500 mg

By M/s Martin

Dow

Pharmaceuticals-

Karachi.

USFDA

Deferred for



Pentahydrate) as

claimed by the firm

171.

-do-

Hyphin Injection 250 mg



to Ceftriaxone 250 mg

Injection (IV)

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

141.4/- per pack

Rocephin

Injection 250 mg

By m/s Martin

Dow

Pharmaceuticals-

Karachi.

USFDA

Deferred for



Pentahydrate) as

claimed by the firm

172.

-do-

Ceftam Injection 2 gm


Cefoperazone Sodium USP

eq to Cefoperazone 1.0 gm

Sulbactam Sodium USP eq

to Sulbactam 1.0 gm Injection

Form 5

04-08-2015

Rs.20,000/-

680/pack

Sulzone Injection

2.0 gm by m/s

Biocare

Laboratories.

Not available in

SRA„s However

the Registration

Approved with one

route of administration

as per innovator (IM or

IV)

Minutes for 253rd


(Cephalosporin)

USP specs.

Board approved the

applied product in

previous meetings

due to its clinical

importance.

Ref:245th meeting

173.

-do-

Ceftam Injection 1.0 gm


Cefoperazone Sodium USP

eq to Cefoperazone 500mg

Sulbactam Sodium USP eq

to Sulbactam 500 mg

Injection

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

400/-

Sulzone Injection

2.0 gm by m/s

Biocare

Laboratories.

Not available in

SRA„s However

the Registration

Board approved the

applied product in

previous meetings

due to its clinical

importance.

Ref:245th meeting

Approved with one



IV)

174.

-do-

Hifime Injection 500 mg


Cefepime Hydrochloride USP

eq to Cefepime 500 mg

Injection

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

445.63/-

Maxipime of

Hospira Inc

Maxipime of GSK,

Karachi.

Approved in 245th

meeting.

Approved with one



IV)

175.

-do-

Hifime Injection 1.0 gm


Cefepime Hydrochloride USP

eq to Cefepime 1.0 gm

Injection

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

839.59/-

Maxipime of

Hospira Inc

Maxipime of GSK,

Karachi.

Approved in 245th

meeting.

Approved with one



IV)

176.

-do-

Cefzid Injection 1.0 gm


Ceftazidime Pentahydrate

USP eq to 1.0 gm

Ceftazidime

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/

Rs.477.00/-

Fortum Injection

1.0 gm by m/s

Glaxosmithkline

Pakistan Ltd

Karachi.

Ceftazidime for

injection, USP is a

sterile, dry-

powdered mixture

of ceftazidime

pentahydrate and

sodium carbonate.

The amount of

sodium carbonate

in the powder for

injection/infusion is

about 118 mg per 1

g of ceftazidime.

Approved with one



IV)

Minutes for 253rd


USFDA, MHRA

177.

-do-

Cefzid Injection 500 mg



USP eq to 500 mg

Ceftazidime

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

254.00/-

Fortum Injection

1.0 gm by m/s

Glaxosmithkline

Pakistan Ltd

Karachi.

Ceftazidime for

injection, USP is a

sterile, dry-

powdered mixture

of ceftazidime

pentahydrate and

sodium carbonate.

The amount of

sodium carbonate

in the powder for

injection/infusion is

about 118 mg per 1

g of ceftazidime.

USFDA, MHRA

Approved with one



IV)

178.

-do-

Cefzid Injection 250 mg



USP eq to 250 mg

Ceftazidime

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

167.00/-

Fortum Injection

250 mg by m/s

Glaxosmithkline

Pakistan Ltd

Karachi.

MHRA

Approved with one



IV)


179. M/s Hi-Medic

pharmaceuticals

private limited

19- km link

multan road

Lahore

Oral Dry Powder

Suspension

Cephalosporin

approved in 242nd

meeting of CLB

held on 08-07-

2015.

Ceftrim Oral Suspension

100mg/5ml

Each 5 ml contains:-

Cefixime USP 100mg/5ml

Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

Rs.286/30 ml

Cefspan Oral

Suspension

100mg/5ml by m/s

Barrett Hodgson

Phramaceuticals

(pvt) Ltd Karachi.

(US-FDA)

Approved.

180. -do- Ceftrim DS Oral Suspension

200mg/5ml


Cefixime USP 200mg/5 ml

Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

Rs.350/30 ml –

Cefspan DS Oral

Suspension

200mg/5ml by m/s

Barrett Hodgson

Phramaceuticals

(pvt) Ltd Karachi.

(US-FDA)

Approved

Minutes for 253rd


181. -do- Cefrad Oral Suspension

250mg/5ml



to Cephradine USP 250mg/5

ml Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

90 ml –

Rs.211.60/-

Velosef Oral

Suspension

250mg/5ml by m/s

Glaxosmithkline

Pakistan Ltd

Karachi, Pakistan

(US-FDA)

Approved

182. -do- Cefrad Oral Suspension

125mg/5ml



to Cephradine USP 125mg/5

ml Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

90 ml – 124.2/-

Velosef Oral

Suspension

125mg/5ml by m/s

Glaxosmithkline

Pakistan Ltd

Karachi, Pakistan

(US-FDA)

Approved

183. -do- Roxil Oral Suspension

125mg/5ml


Cefadroxil Monohydrate eq

to Cefadroxil USP 125mg/5

ml Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

60 ml – 161.63/-

Duricef Oral

Suspension

125mg/5ml by m/s

Glaxosmithkline

Pakistan Ltd

Karachi, Pakistan

(USFDA)

Deferred for

clarification that firm

has demanded pack size

90 ml but fill weight is

30gm/60ml.

184. -do- Clocef Oral Suspension 250

mg/5ml



Cefaclor USP 250 mg/5 ml

Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

60 ml – 328.53/-

Ceclor Oral

Suspension

250mg/5ml by m/s

AGP Karachi,

Pakistan

(US-FDA)

Deferred for the

clarification of Essence

powder flavor.

185. -do- Clocef Oral Suspension 125

mg/5ml



Cefaclor USP 125mg/5 ml

Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

60 ml – 187.94/-

Ceclor Oral

Suspension

125mg/5ml by m/s

AGP Karachi,

Pakistan

(US-FDA)

Deferred for the

clarification of Essence

powder flavor.

186. -do- Farox Oral Suspension

40mg/5ml


Cefpodoxime Proxetil eq to

Cefpodoxime USP 40mg/5

ml Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

50 ml – 338.89/-

Orelox Oral

Suspension

40mg/5ml by m/s

Sanofi Aventis

Karachi, Pakistan

(MHRA)

Approved

Minutes for 253rd


187. -do- Lecef Oral Suspension 250

mg/5ml



to Cephalexin USP 250 mg/5

ml Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

60 ml – 102/-

Ceporex Oral

Suspension

250mg/5ml by m/s

Glaxosmithkline

Pakistan Ltd

Karachi, Pakistan

(USFDA, MHRA)

Approved with change

of brand name

188. -do- Lecef Oral Suspension

125mg/5ml



to Cephalexin USP 125mg/5

ml Suspension

(Cephalosporin)

USP specs.

Form 5

04-08-2015

Rs.20,000/-

60 ml – 61.95/-

Ceporex Oral

Suspension

125mg/5ml by m/s

Glaxosmithkline

Pakistan Ltd

Karachi, Pakistan

(USFDA, MHRA)

Approved

Capsule (General) Section (New License approved in 242nd

Meeting of CLB)

189. Jenner

Pharmaceuticals

(Pvt.) Ltd.

Plot # 3, M2-

Pharma Zone,

26KM, Lahore-

Sharikpur Road,

Shaikhupura –

Pakistan

Sulsin Capsules 0.4mg

Each Capsule Contains:

Tamsulosin Hydrochloride

0.4mg (Pellets)

(Alfa 1-a blocker)

USP Specs.

Pellets source: Vision

Pharmaceuticals,

Islamabad

Dairy Date

28.08.15

Rs: 20000.00

dated 18.08.15

Form 5

As per SRO

10‟s

Flomax Capsules

USA and Japan

Astellas Pharma

MHRA, FDA

Maxflow Cap

(CCL)

Deferred for

confirmation regarding

permission for

Tamsulosin pellets

manufacturing by M/s

vision pharma

Islamabad.

190. -do- Ezol Capsul

es 40mg


Esomeprazole Magnesium

enteric coated pellets

equivalent to Esomeprazole:

40mg

(proton pump inhibitor)

Pellets source: Ocean

Pharmacoat (Pvt) Ltd. Plot

no.44 C.I.E. Ghandi Nagar,

Bolanagar, Hyderabad,

India.

Form 5

Dairy Date

28.08.15

Rs: 20000.00

dated 18.08.15

Rs: 80000.00

Dated 28.08.15

As per SRO

14‟s

Nexium Capsules

By AstraZeneca

UK

1- Nexum (Getz)

2- Purpal (DRL)

Newly Licensed

Unit

Approved. Firm will

submit stability data and

legalized GMP of

pellet‟s manufacturer

and

Chairman Registration

Board will permit

issuance of registration

letter.

191. -do- Eespa SR 200mg Capsules


Mebeverine Hydrochloride as

enteric coated pellets: 200mg

(Smooth muscles relaxant,

anti spasmods)

Pellets source: M/S RA

chem. Pharm, R.S. No.50/1.

Mukteswarapuram,

Jaggaiahpet Manadal,

Form 5

Dairy Date

28.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

Colofac MR

Capsules By

Abbott Health Care

UK

MHRA

Mebever MR

Capsules (Getz)

Deferred for

clarification of

following points.

Registered as modified

release pallets.

Firm has provided only

COA (copy) of pellets

from manufacturer.

COA don‟t shows it as

modified release pellets.

http://epharmaguide.com/Online/Index?ci=1&lstby=%22Tamsolin%22

Minutes for 253rd


Krishna (Dist). A.P.,521175,

India.

192. -do- Meraz Capsules 20mg


Omeprazole as enteric coated

pellets: 20mg

(proton pump Inhibitor)

Pellets source: M/s

Spansules Formulations,

plot No.154, A4, I.D.A.

Bollaram, Hyderabad,

India.

Form 5

Dairy Date

28.08.15

Rs: 20000.00

dated 18.08.15

Rs: 80000.00

Dated 19.08.15

As per SRO

10‟s

Prilosec Capsules

By

AstraZeneca, USA

Risec Capsules

(Getz)

Newly Licensed

Unit

Last inspection as

on 19.05.15

Approved. Firm will

submit stability data and

legalized GMP of pellet‟s

manufacturer and

Chairman Registration

Board will permit issuance

of registration letter.

Dry Powder Suspension (General) Section (New License approved in 242nd

Meeting of CLB)

193. -do- Linolid Dry Suspension

100mg

Each 5ml after reconstitution

contains :

Linezolid : 100mg

(Anti bacterial)

USP Specs.

Form 5

Dairy Date

24.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

60ml

Zyvox Suspension

By

Pharmacia &

Upjohn, UK

MHRA

Zevoxid (Genome)

Approved

194. -do- Azitro Dry Suspension

200mg


contains :

Azithromycin as Dihydrate :

200mg

(Macrolide)

Form 5

Dairy Date

24.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

15ml

Zithromax Powder

for Suspension By

Pfizer Limited, UK

MHRA

Azithrocin Susp by

m/s Bexpharma

Approved

195. -do- Claritro Dry Suspension

125mg


contains :

Clarithromycin : 125mg

(Macrolide)

Form 5

Dairy Date

24.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

60ml

Klaricid

Suspension By

BGP Products

Limited, UK

MHRA

Claritek Susp. By

m/s (Getz)

Deferred for

clarification of

manufacturing method.

Minutes for 253rd


196. -do- Zisel Dry Suspension 10mg


contains :

Zinc sulphate eq to elemental

Zinc: 10mg

(Mineral supplement,

Antidirrial)

(In House)

Form 5

Dairy Date

24.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

60ml

WHO/ UNICEF

recommendation is

for zinc sulphate

10mg/5 ml.

solution.

Yes 2 Zinc (Zafa)

Deferred for

confirmation of

approval by reference

regulatory authority and

commemts/ opinion of

WHO Pakistan.

Dosage

recommendation

(UNICEF/ WHO):

Tablets may contain

either 10 or 20 mg of

zinc and the

concentration of zinc in

oral solutions may be

10mg/5mL. Decisions

about the best strength

to be used should

depend on better

adherence to treatment

by patient, taking into

consideration other

issues as well, such as

price, medicine

delivery, and duration

of treatment (10- or 14-

day treatment).

Preferably, in any

given country, only one

strength of tablets or

oral solution should be

available to avoid

dosing errors. If 10-mg

zinc tablets are chosen,

it will mean that older

children will have to

take two tablets each

day; if 20-mg zinc

tablets are chosen, it

will mean that for

younger infants only

half a tablet will be

given each day and

therefore tablets will

have to be scored to

facilitate this.

With oral solutions,

because it is difficult to

accurately measure

half a teaspoon of

solution, it is

recommended that oral

solution of zinc contain

Minutes for 253rd


10mg of elemental zinc

per 5 mL, that is to say

per one teaspoon. It

means that infants

below 6 months of age

will receive one

teaspoon, while older

children will need 2

teaspoons of oral

solution per day.

(Ref: UNICEF/ WHO)

197. -do- I-Malt Dry Suspension 50mg


contains : Iron III Hydroxide

Polymaltose complex eq. to

Elemental Iron…..50mg

(Iron deficiency & Iron

associated anemia)

IN House Specs.

Form 5

Dairy Date

28.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

60ml

Ferry Suspension

(Tabros)

International

availability not

confirmed.

Deferred for

confirmation of

approval of regulatory

authority

198. -do- Nazole Dry Suspension 50mg


contains :

Fluconazole : 50mg

(anti fungal)

Form 5

Dairy Date

24.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

35ml

Fluconazole

Powedr for

Suspension By

Genus

Pharmaceuticals,

UK

MHRA

Fcozole Susp

(Medicraft)

Approved

Sachet (General) Section (New License approved in 242nd

Meeting of CLB)

199. -do- Montel Satchet 4mg

Each Sachet Contains:

Montelukast as Sodium : 4mg

(Anti-Asthametic)

(in house)

Form 5

Dairy Date

24.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

14‟s

Singulair Granule

By Merck Sharp

and Dohme, UK

MHRA, USFDA

Singulair (OBS

Pharma)

Approved

200. -do- Ronat Sachet 2 gm


Strontium Ranelate : 2 gm

(Osteoprosis, bone diseases)

(granules for oral sachet)

(In House Specs.)

Form 5

Dairy Date

28.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

7‟s

Protelos Sachet By

LES Laboratories

Servier, France

This medicinal

product is subject

to additional

monitoring. This

will allow quick

Approved

Minutes for 253rd


identification of

new safety

information.

Healthcare

professionals are

asked to report any

suspected adverse

reactions.

MHRA

Onita Sachet

(Pharmevo)

201. -do- RC Powder Sachet


Rice Powder (pre-cooked):

6.00 gm

Sodium Citrate: 0.58 gm

Sodium Chloride : 0.35 gm

Potassium Chloride: 0.30gm


(Treatment of electrolytes)

In House Specs.

Form 5

Dairy Date

24.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

10‟s

Dioralyte Sachet

By

Aventis Pharma

Limited, UK

MHRA

Gastrolyte Sachet

(sanofi Aventis)

Approved

202. -do- Smect Sachet 3 gm


Dioctahedral Smectite: 3gm

(Antidiarrhoeal)


In House

Form 5

Dairy Date

28.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

30‟s

Smecta Sachet

(Atco)

Available in france.

Approved in 250th

meeting.

Approved

203. -do- Mebeplus Sachet

135mg/3.5mg


Mebeverine HCl: 135mg

Ispaghula Husk: 3.5gm

(Antispasmodic)


Form 5

Dairy Date

24.08.15

Rs: 20000.00

dated 18.08.15

As per SRO

10‟s

Fybogel

Mebeverine By

Reckitt Benckiser

Healthcare (UK)

MHRA

Mevulak Sachet

(sami)

Approved

New Molecules

204. -do- Lansodex Capsules 30mg


Dexlansoprazole as enteric

coated pellets 30mg

(Proton Pump Inhibtor)

Form 5D

Dairy Date

28.08.15

Rs: 50000.00

dated 19.08.15

Dexilant Capsules

By

Takeda

Pharmaceuticals

Deferred for documents

regarding pellets source

and stability studies as

per 249th meeting of RB

Minutes for 253rd


Pellets source: M/s




India.

Rs 50000.00

28.08.15

As per SRO

10‟s

USA

USFDA

205. -do- Lansodex Capsules 60mg


Dexlansoprazole as enteric

coated pellets 60mg

(Proton Pump Inhibtor)

Pellets source: M/s




India.

Form 5D

Dairy Date

28.08.15

Rs: 50000.00

dated 19.08.15

Rs 50000.00

28.08.15

As per SRO

10‟s

Dexilant Capsules

By

Takeda

Pharmaceuticals

USA

USFDA

Deferred for documents

regarding pellets source

and stability studies as

per 249th meeting of RB

206. -do- Linaclo Capsules 145mcg

Each Capsule Contaiss:

Linaclotide Capsules :

145mcg

(Guanylate cyclase-C recptor

agnoist)

Form 5D

Dairy Date

28.08.15

Rs: 50000.00

dated 19.08.15

As per SRO

10‟s

Linzess Capsules

By

Forest

Laboratories, USA

Deferred for Stability

Data as per giudlines

approved by the board

in 249th meeting not

provided.

207. -do- Linaclo Capsules 290mcg

Each Capsule Contaiss:

Linaclotide Capsules :

290mcg

(Guanylate cyclase-C recptor

agnoist)

Form 5D

Dairy Date

28.08.15

Rs: 50000.00

dated 19.08.15

As per SR

10‟s

Linzess Capsules

By

Forest

Laboratories, USA





provided.

208. -do- Silosin Capsule 4mg


Silodosin 4mg

(Alfa 1-a blocker)

Form 5D

Dairy Date

28.08.15

Rs: 50000.00

dated 19.08.15

As per SRO

10‟s

Rapaflo Capsules

By

Watson Laboratory

USA





provided.

209. -do- Silosin Capsule 8mg


Silodosin 8mg

(Alfa 1-a blocker)

Form 5D

Dairy Date

28.08.15

Rs: 50000.00

dated 19.08.15

As per SRO

10‟s

Rapaflo Capsules

By

Watson Laboratory

USA





provided.

EVALUATOR III M/s PCP Laboratories, Okara


Minutes for 253rd


210. M/s PCP

Laboratories,

98-Km

Multan Road

Akhtarabad,

Okara.

Cephalospori

n dry powder

oral

suspension

approved in

240th meeting

of CLB

PEXIME Suspension 100mg

Each 5ml contains:

Cefixime as

trihydrate…..100mg

Cephalosporin

USP

Form-5

Dy. No 4530

dated 15-07-15

20000/-

As per SRO/

30ml Amber

glass bottle

Suprax 100mg/5ml

(USFDA)

Cefspan of Barrett

Hodgson Karachi


in brand name.

211. -do- PEXIME Suspension 200mg

Each 5ml contains:

Cefixime as


Cephalosporin

USP

Form-5

Dy. No 4543

dated 15-07-15

20000/-

As per SRO/

30ml Amber

glass bottle

Suprax 100mg/5ml

(USFDA)

Cefspan of Barrett

Hodgson Karachi


in brand name.

212. -do- PECEDIN Suspension 250mg

Each 5ml contains:

Cefradine……..250mg

Cephalosporin

USP

Form-5

Dy. No 4528

dated 15-07-15

20000/-

As per SRO/

60ml Amber

glass bottle

Valosef of

Apothecon

(USFDA)

Valosef of GSK

Karachi

Approved

213. -do- PECEDIN Suspension 125mg

Each 5ml contains:

Cefradine…………..125mg

Cephalosporin

USP

Form-5

Dy. No

4535dated 15-07-

15

20000/-

As per SRO/

60ml Amber

glass bottle

Valosef of

Apothecon

(USFDA)

Valosef of GSK

Karachi

Approved

214. -do- PEDROX Suspension 250mg

Each 5ml contains:

Cefadroxil as monohydrate

Cephalosporin

USP

Form-5

Dy. No 4526

dated 15-07-15

20000/-

As per SRO/

60ml Amber

glass bottle

Cefadroxil

Suspension

(USFDA)

Duracef of GSK

Karachi

Approved

215. -do- PECHLOR Suspension 125mg

Each 5ml contains:

Cefaclor….125mg

Cephalosporin

BP

Form-5

Dy. No 4542

dated 15-07-15

20000/-

As per SRO/

60ml Amber

glass bottle

Cefaclor

Suspension

(USFDA)

Duracef of GSK

Karachi

Approved

Minutes for 253rd


216. -do- PECHLOR Suspension 250mg

Each 5ml contains:

Cefaclor….250mg

Cephalosporin

BP

Form-5

Dy. No 4542

dated 15-07-15

20000/-

As per SRO/

60ml Amber

glass bottle

Cefaclor

Suspension

(USFDA)

Duracef of GSK

Karachi

Approved

217. -do- PROXIME Suspension 125mg

Each 5ml contains:

Cefuroxime as axetil….125mg

Cephalosporin

Manufacturer

Form-5

Dy. No 4533

dated 15-07-15

20000/-

As per SRO/

60ml Amber

glass bottle

Cefuroxime

Suspension

(USFDA)

Daycef of Shrooq

Pharma

Approved

218. -do- PEFALEX Suspension 125mg

Each 5ml contains:

Cefalexin as

monohydrate…..125mg

Cephalosporin

USP

Form-5

Dy. No 4536

dated 15-07-15

20000/-

As per SRO/

60ml Amber

glass bottle

Keflex of Shiongi

(USFDA)

Keflex of AGP

Karachi

Approved

219. -do- PEFALEX Suspension 250mg

Each 5ml contains:

Cefalexin as


Cephalosporin

USP

Form-5

Dy. No 4537

dated 15-07-15

20000/-

As per SRO/

60ml Amber

glass bottle

Keflex of Shiongi

(USFDA)

Keflex of AGP

Karachi

Approved

Capsule (Cephalosporin)

220. M/s PCP

Laboratories,

98-Km

Multan Road

Akhtarabad,

Okara.

(Cephalospori

n dry powder

oral

suspension) in

241st meeting

of CLB

PEFALEX Capsules 500mg

Each capsule contains:

Cefalexin as


Cephalosporin

USP

Form-5

Dy. No 4529

dated 15-07-15

20000/-

As per SRO/

Pack of 1x12‟s

Keflex of Shiongi

(USFDA)

Keflex of AGP

Karachi

Approved

Minutes for 253rd


221. -do- PEFALEX Capsules 250mg


Cefalexin as


Cephalosporin

USP

Form-5

Dy. No 4540

dated 15-07-15

20000/-

As per SRO/

Pack of 1x12‟s

Keflex of Shiongi

(USFDA)

Keflex of AGP

Karachi

Approved

222. -do- PROXIME Capsules 250mg



Cephalosporin

Manufacturer

Form-5

Dy. No 4524

dated 15-07-15

20000/-

As per SRO/

Pack of 1x12‟s

Not found in

stringent SRA‟s

Daycef of Sharooq

Pharma Lahore

Deferred for

confirmation of

approval of reference

regulatory authorities.

223. -do- PROXIME Capsules 500mg



Cephalosporin

Manufacturer

Form-5

Dy. No 4527

dated 15-07-15

20000/-

As per SRO/

Pack of 1x12‟s

Not found in

stringent SRA‟s

Trucef of Synchro

Pharma

Deferred for

confirmation of


regulatory authorities.

224. -do- PECEDIN Capsules250mg



Cephalosporin

BP

Form-5

Dy. No 4525

dated 15-07-15

20000/-

As per SRO/

Pack of 1x12‟s

Valosef of

Apothecon

(USFDA)

Valosef of GSK

Karachi

Approved

225. -do- PECEDIN Capsules500mg



Cephalosporin

BP

Form-5

Dy. No 4534

dated 15-07-15

20000/-

As per SRO/

Pack of 1x12‟s

Valosef of

Apothecon

(USFDA)

Valosef of GSK

Karachi

Approved

226. -do- PEDROX capsules 500mg


Cefadroxil as

Form-5

Dy. No 4532

dated 15-07-15

Cefadroxil capsules

(USFDA)

Duracef of GSK

Approved

Minutes for 253rd


monohydrate….500mg

Cephalosporin

USP

20000/-

As per SRO/

Pack of 1x12‟s

Karachi

227. -do- PECHLOR capsules 500mg


Cefaclor….500mg

Cephalosporin

BP

Form-5

Dy. No 4538

dated 15-07-15

20000/-

As per SRO/

Pack of 1x12‟s

Cefaclor capsules

(USFDA)

Duracef of GSK

Karachi

Approved

228. -do- PECHLOR capsules 250mg


Cefaclor….250mg

Cephalosporin

BP

Form-5

Dy. No 4538

dated 15-07-15

20000/-

As per SRO/

Pack of 1x12‟s

Cefaclor capsules

(USFDA)

Duracef of GSK

Karachi

Approved

229. -do- PEXIME Capsules 400mg


Cefixime as


Cephalosporin

USP

Form-5

Dy. No 4531

dated 15-07-15

20000/-

As per SRO/

Pack of 1x5‟s

Suprax (USFDA)

Cefspan of Barrett

Hodgson Karachi

Approved

Minutes for 253rd


Case no 4 :- ADDITIONAL SECTIONS CASES

EVALUATOR I

M/s Wilshire Laboratories, Lahore

Injection (Psychotropic/Narcotics)

230. M/s Wilshire

Laboratories (Pvt)

Ltd, 124/1, Quaid-e-

Azam Industrial

Estate, Kot

Lakhpat, Lahore.

Liquid Injection

(Psychotropic/Narc

otics) Ampoule

approved in 241st

meeting of CLB

dated 15-05-2015.

Reqnyl Injection

Each ml contains

Fentanyl Citrate eq to

fentanyl....50mcg

Narcotic Analgesic

USP Specifications

Form-5

07-07-2015 diary

No 7300.

Rs20,000

As per SRO

471(I)93

Fentanyl Citrate, USA,

Abbott

Fentra by M/s Brookes

Pharma

Approved

231. -do- Efed Injection

Each ml contains

Ephedrine

hydrochloride....30mg

Sympathomimetic

B.P Specifications

Form-5

07-07-2015 diary

No 7302.

Rs20,000

As per SRO

471(I)93

Ephedrine HCL, UK,

by M/sAuden

Vepressor by M/s

Venus Pharma

.

Approved

232. – -do- Zultra Injection

Each 2ml contains

Tramadol

Hydrochloride..100mg

Opiod Analgesic

Manufacturer‟s

Specifications

Form-5

07-07-2015 diary

No 7305.

Rs20,000

As per SRO

471(I)93

Tramadol HCL

injection, UK, by M/s

Brown & Burk.

Tamadol by M/s

Highnoon Pharma

Approved

233. -do- Zultra Injection

Each ml ampoule

contains Tramadol

Hydrochloride..50mg

Opiod Analgesic

Manufacturer‟s

Specifications

Form-5

07-07-2015 diary

No 7296.

Rs20,000

As per SRO

471(I)93

Tramadol HCL

injection, UK, by M/s

Brown & Burk.

Tamadol by M/s

Highnoon Pharma

Approved

Minutes for 253rd


234. -do- Qonza Injection

Each ml contains

Morphine

Sulphate..15mg

Narcotic Analgesic

B.P Specifications

Form-5

07-07-2015 diary

No 7301.

Rs20,000

As per SRO

471(I)93

Morphine Sulphate

injection, USA, by

M/s Meridian.

Morphine Sulphate

injection by M/s PDH

Approved

235. -do- Opronex Injection

Each ml contains

Buprenorphine

Hydrochloride eq. to

Buprenorphine..0.3mg

Narcotic Analgesic

B.P Specifications

Form-5

07-07-2015 diary

No 7304.

Rs20,000

As per SRO

471(I)93

Buprenex injection,

USA, by M/s Reckit.

Temgesic injection by

M/s Reckit

Approved

236. -do- Pentalop Injection

Each ml contains

Pentazocine Lactate eq

to Pentazocine...30mg

Narcotic Analgesic

B.P Specifications

Form-5

07-07-2015 diary

No 7303.

Rs20,000

As per SRO

471(I)93

Talwin injection,

USA, by M/s Hospira.

Sosegon injection by

M/s Sanofi

Approved

237. -do- Phenoject Injection

Each ml ampoule

contains phenobarbitone

Sodium...200mg

Long acting Barbiturates

B.P Specifications

Form-5

07-07-2015 diary

No 7297.

Rs20,000

As per SRO

471(I)93

Phenobarbitone

sodium injection, UK,

by M/s Macarthys.

Phenobarb injection

by M/s Acto

Approved

238. -do- Relax Injection

Each 2ml contains

Diazepam...10mg

Benzodiazepine

B.P Specifications

Form-5

07-07-2015 diary

No 7299.

Rs20,000

As per SRO

471(I)93

Valium injection,

USA, by M/s Roche.

Valium injection by

M/s Martin Dow

Approved

Minutes for 253rd


239. -do- Qotum Injection

Each ml contains

Nalbuphine HCl...20mg

Narcotic Analgesic

Manufacturer

Specifications

Form-5

07-07-2015 diary

No 7298.

Rs20,000

As per SRO

471(I)93

Nubain injection,

USA, by M/s Endo

Pharms.

Kinzs injection by M/s

Sami

Approved

M/s Aventek Pharmaceuticals, Lahore

Tablet (General)

240. M/s Aventek

Pharmaceuticals

(Pvt) Ltd., 44-C,

Sunder Industrial

Estate, Lahore.

Tablet (General)

section approved by

Central Licensing

Board in its 239th

meeting held on 22-

01-2015.

POXETINE 60mg

Tablet

Each

tabletcontains:

Dapoxetine (as

HCl) ….60mg

Antidepressant

Manufacturers

specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1494

R&I

Price: Rs. 830/-

10‟s

Deferred for

submission of

following:

1) Antidepressant

has been

mentioned as

pharmacological

group, whereas,

premature

ejaculation has

been mentioned

under proposed

indications.

Clarification

required.

2) Undertaking

that label claim

and prescribing

information shall

be same as

approved by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada.

3) Evidence of

approval of same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada.

4) Evidence of

me too status

required.

5) Source of

Deferred for confirmation of me too

status

Minutes for 253rd


active and in-

actives along

with their role

and justification

for quantity used.

6) Details of

reference

standard

required.

7) Evidence of

approval of

technical staff by

licensing

required.

8) Verification of

Rs. 12,000/- and

Rs. 8,000/- fee

challan required.

241. -do-

AVEMOX400mg

Tablet

Each tablet

contains:

Moxifloxacin (as

Hcl) ….400mg

Quinolones

Manufacturers

specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1503

R&I

Price: Rs. 475/-

5‟s

AVELOX

400mg f/c tablet

US FDA

AVELOX

400mg f/c tablet

M/s Bayer

Approved

242. -do-

AVEFLOX250mg

Tablet

Each

tabletcontains:

Levofloxacin (as

Hemihydrate)

…………...

250mg

Quinolones

USP specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1501

R&I

Price: Rs. 250/-

10‟s

LEVAQUIN

250mg f/c tablet

US FDA

TAVANIC

250mg tablet

M/s Sanofi

Approved with the change of name.

243. -do-

AVEFLOX

500mg Tablet

Each

tabletcontains:

Form 5

Rs. 8,000/-

Dated 26-06-

2012

LEVAQUIN

500mg f/c tablet

US FDA

TAVANIC


Minutes for 253rd


Levofloxacin (as

Hemihydrate)

…………...

500mg

Quinolones

USP specifications

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1495

R&I

Price: Rs. 415/-

10‟s

500mg tablet

M/s Sanofi

244. -do-

AVEROXIN

250mg Tablet

Each

tabletcontains:

Ciprofloxacin (as

Hcl) ……...

250mg

Quinolones

BP specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1499

R&I

Price: Rs. 180/-

10‟s

CIPRO

250mg f/c tablet

US FDA

CIPROXIN

250mg tablet

M/s Bayer


245. -do-

AVEROXIN

500mg Tablet

Each

tabletcontains:

Ciprofloxacin (as

Hcl) ……...

500mg

Quinolones

BP specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 16-03-

2015

Dy. No. 1708

R&I

Price: Rs. 180/-

10‟s

CIPRO

500mg f/c tablet

US FDA

CIPROXIN

500mg tablet

M/s Bayer


246. -do-

GLIPTIN 50mg

Tablet

Each

tabletcontains:

Vildagliptin…

50mg

Anti diabetic

Manufacturers

specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 16-03-

2015

Dy. No. 1706

R&I

Price: Rs. 2112/-

28‟s

GALVUS

50mg tablet

TGA

GALVUS

50mg tablet

M/s Novartis


Minutes for 253rd


247. -do-

AVETOSE-F

Tablets

Each tablet

contains:

Iron Polymaltose

complex…..100m

g

Folic

acid….0.35mg

Haematinic

Manufacturers

specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 16-03-

2015

Dy. No. 1705

R&I

Price: Rs. 200/-

2x10‟s

FEROSOFT FA

100/0.35mg

M/s Hilton

Approved.

248. -do-

AVEGREL

Tablets

Each

tabletcontains:

Clopidogrel…….

75mg

Aspirin…75mg

Antiplaletst,

analgesic

antipyretic

Manufacturers

specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1504

R&I

Price: Rs.110/-

2x10‟s

Deferred for

submission of

following:

1) Undertaking

that label claim

and prescribing

information shall

be same as

approved by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada.

Moreover,

indications to be

revised

accordingly.

2) Master

formulation and

manufacturing

method for plain

tablet have been

submitted.

However,

internationally

Rejected as the firm does not have

the facility for the formulation of

this drug.

Minutes for 253rd


the product is

available as a

bilayer tablet.

Rectification

required.

Moreover,

evidence of

availability of

manufacturing

facility for

bilayer tablet

required.

3) Label claim to

be revised in

accordance to

internationally

approved

formulations.

4) Batch size,

quantities to be

used per batch,

source of active

and in-actives

along with their

role and

justification for

quantity used

required.

5) Finished

product

specifications to

be revised as per

internationally

available

formulation.

6) Details of

reference

standard

required.

7) Evidence of

approval of

technical staff by

licensing

required.

Firm has

requested to

change the

formulation as

single ingredient

formulation

Minutes for 253rd


249. -do- AVELUME

Each tablet

contains:

Artemether...80mg

Lumefantrine…

480mg

Synthetic

antimalarial

derived from

artemisinin/Synthe

tic recemic

fluorine mixture.

(USP Salmous

Spec.s)

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 16-03-

2015

Dy. No. 1704

R&I

Price: 264/- per

pack.

8‟s

ARCEVA

M/s Sami

Approved

Capsule (General)

250. Capsule (General)

section approved by

Central Licensing

Board in its 239th

meeting held on 22-

01-2015.

AVEOME 20mg

Capsule

Each capsule

contains:

Omeprazole…….

20mg (BP)

Proton pump

inhibitor

Manufacturer

Source of pellets:

M/s Smilax

Laboratories

Limited.,

Plot No. 12/A,

Phase-III, I.D.A.,

Jeedimetla,

Hyderabad – 500

055, Telangana

State

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1502

R&I

+ Rs. 80,000/-

dated 15.03.15

Price: Rs.200/-

per pack

FDA Losec 20mg

RISEK

M/s Getz

Approved. and the Chairman

Registration Board is authorized to

issue the letter after obtaining the

stability data and Legalized GMP.

251. -do- AVEOME 40mg

Each Capsule

contains:

Omeprazole

……...40mg (BP)

Proton pump

inhibitor

Manufacturer

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 16-03-

2015

Dy. No. 1707

R&I

FDA Losec 40mg

RISEK

M/s Getz

Approved. Firm will submit

stability data and legalized GMP of

pellet‟s manufacturer and

Chairman Registration Board will

permit issuance of registration letter.

Minutes for 253rd


Source of pellets:

M/s Smilax

Laboratories

Limited.,

Plot No. 12/A,

Phase-III, I.D.A.,

Jeedimetla,

Hyderabad – 500

055, Telangana

State

+ Rs. 80,000/-

dated 15.03.15

Price: As per

DRAP Policy

252. -do- DIATEK Capsule

Each Capsule

contains:

Diacerein…….

50mg

Anti Osteoarthritis

Manufacturers

specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1505

R&I

Price: Rs.810/-

Per pack

DIORA

50mg Capsules

M/s Getz

Defered as the Formulation is under

review

253. -do- TRANSOBIQ

Each Capsule

contains:

Tranexamic acid

…….500mg

Hemostatic

Manufacturers

specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 16-03-

2015

Dy. No. 1711

R&I

Price: 325/-

2x10‟s

MAXNA

500mg Capsules

M/s AGP

Approved

254. -do- AOXTINE

Each Capsule

contains:

FluxetineHcleq to

Fluoxetine 20mg

5-HT reuptake

inhibitor

B.P specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 16-03-

2015

Dy. No. 1710

R&I

Price: 75/- per

pack.

FLUOXETINE

HYDROCHLOR

IDE

20mg Capsules

US FDA

DEPEX

M/s Merck

Approved

Minutes for 253rd


255. -do- AZTRO 250mg

Capsule.

Each Capsule

contains:

Azithromycin

Dihydrate eq. to

Azithromycin

…..250mg

Macrolides

Manufacturers

specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1498

R&I

Price: 320/- per

pack.

10‟s

ZITHROMAX

250mg capsule

TGA

AZOMAX

250mg Capsules

M/s Novartis

Approved

256. -do- ALENSO 30mg

Capsule.

Each Capsule

contains:

Lansoprazole

……… 30mg

Proton pump

inhibitor

Manufacturers

specifications

Source of pellets:

M/s Smilax

Laboratories

Limited.,

Plot No. 12/A,

Phase-III, I.D.A.,

Jeedimetla,

Hyderabad – 500

055, Telangana

State

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1496

R&I

+ Rs. 80,000/-

dated 15.03.15

Price: 206/- per

pack.

14‟s

PREVACID

30mg capsule

US FDA

LANZOL

30mg Capsules

M/s Pharmatec






257. -do- AESMOL

Each Capsule

contains:

Esomeprazole

Magnesium eq. to

Esomeprazole

……….. 40mg

Proton pump

inhibitor

Source of pellets:

M/s Smilax

Laboratories

Limited.,

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1497

R&I

+ Rs. 80,000/-

dated 15.03.15

Price: 323/- per

pack.

NEXIUM

40mg capsules

US FDA

NEXUM

M/s Getz






Minutes for 253rd


Plot No. 12/A,

Phase-III, I.D.A.,

Jeedimetla,

Hyderabad – 500

055, Telangana

State

258. -do- AESMOL

Each Capsule

contains:

Esomeprazole

Magnesium eq. to

Esomeprazole

……….. 20mg

Proton pump

inhibitor

Manufacturers

specifications

Source of pellets:

M/s Smilax

Laboratories

Limited.,

Plot No. 12/A,

Phase-III, I.D.A.,

Jeedimetla,

Hyderabad – 500

055, Telangana

State

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 09-03-

2015

Dy. No. 1500

R&I

+ Rs. 80,000/-

dated 15.03.15

Price: 198/-

14‟s

NEXIUM

20mg capsules

US FDA

NEXUM

M/s Getz






259. -do- Avegab 100mg

Capsules

Each Capsule

contains:

Pregabalin

……….… 100mg

Antiepileptic

Manufacturers

specifications

Form 5

Rs. 8,000/-

Dated 26-06-

2012

Rs. 12,000/-

Dated 16-03-

2015

Dy. No. 1709

R&I

Price: 259/- per

pack 14‟s

LYRICA

100mg Capsule

US FDA

GABICA

100mg Capsules

M/s Getz

Approved

Minutes for 253rd


Evaluator – I

M/s Fynk Pharmaceuticals, Lahore

Cream/Ointment/Gel (Steroid)

260. M/s Fynk

Pharmaceuticals

19-Km G.T Road,

Kalashah Kaku,

Lahore.

Cream

/Ointment/Gel

(Steroid) approved

in 239th meeting of

Central Licensing


2015.

Dermit Cream

Clobetasol

propionate B.P.

0.05%

(Corticosterides)

(B.P

Specifications)

Form 5

(03.07.2014)

Dy. No. 1112

Rs.20,000

As per DRAP

policy/5gm &

15gm

BNF:

Dermovate®

(GSK) Cream

(clobetasol

propionate

0.05%),

Biovate

(Wisdom)

Approved

261. -do- Kandax N Cream

15gm

Dexamethasone

Phosphate (as

Disodium USP)

0.1%, Neomycin

(as Sulphate USP)

0.5%

(Corticosterides &

antibacterial)

Manufacturer‟s

specifications

Form 5

30.-07-2014,

vide Dy No.

1121

As per SRO/15

gm

Dexa-N Cream ,

Swiss Pharma

Defered for confirmation of

approval by regulatory authority of

reference countries.

262. -do- Fusirum B Cream

Fusidic Acid 2%

and

betamethasone

0.1%

Corticosteroid &

antibacterial

Manufacturer‟s

specifications

Form 5

03.-07-2014,

vide Dy No.

1127

As per

SRO/5gm &15

gm

Fucibet cream

UK

Fusimin B by M/s

Sharooq

Approved

263. -do- Fusirum-H Cream

Fusidic Acid 2%

and

Hydrocortisone

acetate 1%

Corticosteroid &

antibacterial

Manufacturer‟s

specifications

Form 5

03.-07-2014,

vide Dy No.

1119

As per SRO/15

gm

Fucidin H cream

UK

Fucidin H cream

by M/s Zam zam

Approved

Minutes for 253rd


264. -do- Fengen HC Cream

Gentamicin(as

sulphate)B.P…

0.3%

Hydrocortisone

AcetateB.P….1.0

%

Corticosteroid &

antibacterial

Manufacturer‟s

specification

Form 5

03.-07-2014,

vide Dy No.

1109

As per SRO/

10 gm




265. -do- Benovit N Cream

Each gram

contains

Betamethasone (as

Valerate B.P)0.1%

and Neomycin (as

Sulphate B.P)

0.5%

Corticosteroid &

antibacterial

Manufacturer‟s

specifications

Form 5

03.-07-2014,

vide Dy No.

1127

As per

SRO/5gm &15

gm

BNF Betnovate N

Betnovate N

cream GSK

Approved with the change of name

266. -do- Benovit Cream

Each gram

contains

Betamethasone (as

Valerate B.P)0.1%

Corticosteroid

B.P specifications

Form 5

03-07-2014,

vide Dy No.

1126

As per

SRO/5gm &15

gm

Betnovate cream

GSK UK

Betnovate cream

by M/s GSK

Approved with the change of name

267. -do- B-Nate Cream

Betamethasone (as

Dipropionate

B.P)0.05% and

Gentamicin (as

Sulfate B.P) 0.1%

Corticosteroid &

antibacterial

Manufacturer‟s

Specifications

Form 5

03-07-2014,

vide Dy No.

1115

As per SRO/15

gm

DIPROGEN

Cream of Merck

(Health Canada)

Diprogenta

(Atco)

Approved

Minutes for 253rd


268. -do- Fermicon H

Cream

Hydrocortisone

B.P 1% and

Miconazole

Nitrate B.P 2%

Corticosteroid &

antifungal

B.P specification

Form 5

03-07-2014,

vide Dy No.

1380

As per SRO/10

gm

Daktacort

Hydrocortisone

Cream UK

Mycon (Valor)

Approved

269. -do- Orimazole-HC

Cream

Clotrimazole B.P

1% and

HydrocortisoneB.

P 1%

Corticosteroid &

antifungal

Manufacturer‟s

Specifications

Form 5

03-07-2014,

vide Dy No.

1110

As per SRO/

10 gm

Canesten HC

Cream UK

Clozox H

(Shaigan)

Approved

270. -do- Fosmin Cream

Contains:-

Isotretinoin

B.P…0.05% w/w

Vitamin A

analogue

(retinoid);

Treatment of Acne

Manufacturer‟s

Specifications

Form 5

R&I 1381, 04-

03-2015

Rs.20,000

As per

SRO/10gm

Acutane of Roche

USA as approved

in 243rd

meeting

Isotrol Cream

Valor Pharma




271. -do- Locin Gel

Contains:-

Lignocaine HCl

Anhydrous B.P.

2% w/w

(Local

Anesthetics)

(B.P.

Specifications)

Form 5

R&I 203

14-01-2015,

Rs. 20,000/-

As Per SRO/15

Gm

Australia:

Xylocaine 2%

Jelly

(AstraZeneca Pty

Ltd)

XYLOCAINE

(BARRET

HUODGSON)

Grant of

additional section

Cream/Ointment

(General and

Steroidal)

Approved

Minutes for 253rd


M/s Ipram International, Islamabad.

Capsule (Cephalosporin)

272. M/s Ipram

International, Plot

# 26, S-S-3,

National Industrial

Zone, Rawat,

Islamabad.

Capsule

(Cephalosporin)secti

on approved

by Central

Licensing Board in

its 239th meeting

held on 22-01-

2015 (vide letter

No. F. 1-13/98-Lic

[Vol-I] dated

25/02/2015)

Ipraceph 500mg

Capsule.

Each Capsule

Contains:-

Cephradine

U.S.P.……500mg

Anti-Biotic,

1stGeneration

Cephalosporin

Form 5

Rs.20000/-

Dy. No. 9787

R&I

Dated 19-11-

2012

Price: As fixed

by

Govt. 2x6‟s

NICEF 500mg

Capsules

Cefradine

MHRA

VELOSEF

500mg Capsules

GSK

Approved

273. -do- Mecef 500mg

Capsule.

Each Capsule

Contains:-

Cefadroxil

BP…………500m

g

Anti-Biotic, 1st

Generation

Cephalosporin

Form 5

Rs.20,000/-

Dy. No. 9788

R&I

Dated 19-11-

2012

Price: As fixed

by

Govt.

2x6‟s

CEFADROXIL

(as monohrdrate)

500mg

US FDA

DURICEF

500mg

GSK

Approved

274. -do- Cilicef 200mg

Capsule.

Each Capsule

Contains:-

Cefixime as

trihydrate

……200mg

Anti-Biotic,

Cephalosporin

Form 5

Rs.20000/-

Dy. No. 9786

R&I

Dated 19-11-

2012

Price: As fixed

by

Govt.

Firm has

mentioned

SUPRAX 200mg

of M/s Lupin

USA. However,

the FDA

approved strength

of SUPRAX is

400mg capsule.

CEFIM

200mg Capsules

M/s Hilton

Rejected as the formulation is not

internationally available in same

strength and dosage form.

275. -do- Ipraclor 500mg

Capsule.

Each Capsule

Contains:

Cefaclor

U.S.P….500mg

Anti-Biotic, 2nd

Generation

Cephalosporin

Form 5

Rs.20000/-

21-01-2015

Dy. No. 405

R&I

Price: As fixed

by

Govt.

2x6‟s

BNF.cefaclor

500mg capsule

CECLOR

M/s AGP

Approved

Minutes for 253rd


276. -do- Cilicef 400mg

Capsule.

Each Capsule

Contains:

Cefixime as

trihydrate….400m

g

Antibiotic

(Cephalosporin)

Form 5

Rs.20000/-

Dy. No. 9785

R&I

Dated 19-11-

2012

Price: As fixed

by

Govt.

SUPRAX 400mg

Capsule

US FDA

CEBOSCH

400mg capsule

M/s Bosch

Approved

EVALUATOR IV

M/s Mallard Pharmaceuticals, Multan

Veterinary Injectable Vials (General / General Antibiotics)

277. M/s Mallard

Pharmaceuticals

(Pvt.) Ltd, 23-km

Lahore Road,

Multan.

ADDITIONAL

SECTION:

Veterinary

Injectable Vials

(General / General

Antibiotics) approved in 241

st

meeting of CLB

Gentamall Liquid

Injection

Each ml contains

Gentamycin

Sulphate Eq to

100 mg

Gentamycin Base

Antibiotics

(BP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

303 dated 29-

08-2015

Pack of

10 ml, 50 ml,

100 ml

Garasol Injection

100mg / ml

(Merck Animal

Health,USA)

Genex (My Lab

Pvt. Ltd)

Approved with condition of one

pack size only.

278. -do- Ivermall 1%

Injection

Each ml contains

Ivermectin 10 mg

Anthelmintic

(BP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

301 dated 29-

08-2015

Pack of

10 ml, 50 ml,

100 ml

Qualimec Vet

(ECO Animal

Health Ltd,UK)

Wormec

Injection

(Nawan)


pack size only.

Minutes for 253rd


279. -do- Novamall

Injection

Each 100 ml

contains

Etilefrin (as HCl)

BP 0.2 mg

Caffein BP 10 mg

Sodium Salicylate

BP 7 mg

Novaminsulfon

BP 40 mg

Nicotinamide BP

0.3 mg

Calcium

Gluconate USP

100 mg

Magnesium

Gluconate USP 10

mg

Boric Acid BP 10

mg

Sorbitol 200 mg

Sodium Oxy

benzylphosphoric

acid 5 mg

Methyl

Parahydroxy

Benzoate 0.7 mg

Analgesic &

Antipyretic

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

299 dated 28-

05-2015

Pack of

100 ml, 250 ml,

500 ml

Not provided

Novastar

Injection (Star

Laboratories)

Deferred for confirmation of

validity of the testing method and

for provision of one pack size

only.

280. -do- Fluxin Injection

50mg/ml

Each 100 ml

contains

Flunixin

Meglumine eq to

Flunixine Base 5

gm

Analgesic/Antipyr

etic

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

298 dated 29-

05-2015

Pack of

10 ml, 50 ml,

100 ml

Benamine

Injection

Approved by

FDA vide

NADA #101-

479.

FLUZAK

(ZAKFAS)


pack size only.

Minutes for 253rd


281. -do- Meloxmall

Injection

Each ml contains

Meloxicam 10 mg

NSAID

(BP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

296 dated 29-

05-2015

Pack of

50 ml, 100 ml,

200 ml

Metacam

5mg/ml, FDA

approved

Meloxi-10

(SELMORE)

Deferred for clarification of

proposed dosage form because

international the product is

available in strength 5mg/ml.

282. -do- Hepamall

Injection

Each 100 ml

contains Phenoxy-

2methyl-2-

propionic acid 10

gm

Liver Tonic

(Manufcature

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

296 dated 29-

05-2015

Pack of

50 ml, 100 ml

HEPAGEN 100

mg/ml (Fatro,

Italy)

Hepaguard (Star

Lab)

Deferred for clarification

regarding indication and usage.

283. -do- Synogent Injection

Each ml contains

Gentamycin

Sulphate BP 50

mg

Tylosin Tartrate

BP 100 mg

Antibiotics

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

296 dated 29-

05-2015

Pack of

20ml, 50 ml,

100 ml

Taylogen

Injection IM

(Vilsan, turkey)

Genta T Coli

Injection (Alina)


pack size only.

284. -do- Bursamall

Injection

Each ml contains

Trimethoprim 80

mg

Sulphdiazine 400

mg

Antibiotics

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

296 dated 29-

05-2015

Pack of

10ml, 50 ml,

100 ml

Tribressin 48%

(Schering plough

animal health,

New Zealand)

Altrim Plus

Injection (Alina)

Approved

285. -do- Bursamall

Injection

Each ml contains

Oxytetracycline

Form 5

Rs. 20,000/-

vide Dy. No.

304 dated 29-

05-2015

FDA approved

oxytetracycline

injection

Oxyla 5%


pack size only.

Minutes for 253rd


HCl eq to

Oxytetracycline

base 50 mg

Antibiotics

(Manufacture

Specification)

Pack of

10ml, 50 ml,

100 ml

Injection (Alina)

286. -do- DIMALL 33.33%

Injection

Each 100 ml

contains

Sulphadimidine

Sodium 33.33 gm

Sulphonamide

Antibiotics

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

308 dated 29-

05-2015

Pack of

100 ml, 500 ml

Sulphadimidine

Sodium 33.3 %

injection IM

(UCCMA,

Egypt)

Sulfavet (Zakfas)

Deferred for the clarification of

pack size 500 ml which is LVP.

EVALUATOR IV

M/s Hamaz Pharmaceuticals, Multan

Liquid Injectable (Ampoule/Vial) (General and General Antibiotics)

287. M/s Hamaz

Pharmaceuticals

(Pvt.) Ltd, 13-km,

Lutafabad, Bosan

Road, Multan

ADDITIONAL

SECTION -

Liquid Injectable

(Ampoule/Vial)

(General and

General

Antibiotics) approved in 242

nd

meeting of CLB

Vialox IV

Infusion

Each 100 ml

contains Ofloxacin

HCl 220 mg eq to

Ofloxacin 200 mg

Quinolone

Antibiotics

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4808 dated 04-

08-2015

Pack of

1 x 100 ml/

price 768.

MHRA approved

Tarivid

Adios (Wilshire)

Deferred for clarification from

Central Licensing Board

regarding separate section for

ampoule and vials.

288. -do- Spizole IV

Infusion

Each 100 ml bottle

contains

Metronidazole 500

mg

Quinolone

Antibiotics

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4810 dated 04-

08-2015

Pack of

1 x 100 ml/

price 78.

FDA approved

Flagyl

ANAROB

(Global)




ampoule and vials.

Minutes for 253rd


289. -do- Nixin IV Infusion

Each 100 ml bottle

contains

Ciprofloxacin (as

Lactate) 200 mg

Quinolone

Antibiotics

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4844 dated 04-

08-2015

Pack of

1 x 100 ml/

price 971.

FDA approved

Ciproxin (Bayer)

Caralox

(Caraway)




ampoule and vials.

290. -do- Flikz IV Infusion

Each 50 ml bottle

contains

Fluconazole 100

mg

Antifungal Trizole

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4840 dated 04-

08-2015

Pack of

1 x 50 ml/ price

560.

FDA Fluconazole

Injection (Hikma

farmaceutica)

Lunim (Nimrall)




ampoule and vials.

291. -do- Flacin IV Injection

600 mg

Each Vial 02 ml

contains

Lincomycin as

HCl 600mg

Lincosamide

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4837 dated 04-

08-2015

Pack of

1 x 02 ml vials /

price 55.

Deferred for

clarification

from Central

Licensing Board

regarding

separate section

for ampoule and

vials.

05 ampoules /

price 255

FDA approved

Lincocin (Pfizer)

Viocin (Venus)




ampoule and vials.

Minutes for 253rd


292. -do- Linor IV Injection

200 mg

Each 100 ml

contains Linezolid

200mg

Oxazolidinone,

Antibiotic

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4831 dated 04-

08-2015

Pack of

1 x 100 ml vial /

price 346.

1 x 200 ml vial/

price 400

1 x 300 ml vial /

Price 600

FDA approved

Linezolid

(Sandoz)

Zolrest (Bosch)




ampoule and vials.

293. -do- Lupin IV Infusion

500 mg

Each 100 ml

contains

Levofloxacin

500mg

Quinolone

Antibiotic

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4830 dated 04-

08-2015

Pack of

1 x 100 ml vial /

price 300.

FDA approved

Livaquin

(Johnson)

Leflox (Getz)




ampoule and vials.

294. -do- I-MOX IV

Infusion 400 mg

Each 250 ml

contains

Moxifloxacin as

HCl 400 mg

Quinolone

Antibiotic

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4830 dated 04-

08-2015

Pack of

1 x 250 ml vial /

price 1250.

FDA approved

Avelox(Bayer)

Goldspec

(Nimrall)




ampoule and vials.

295. -do- ESTADOL IV

Infusion 1g

Each 100 ml

contains

Paracetamol

USP… 1 gm

Antipyretic /

analgesic

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4816 dated 04-

08-2015

Pack of

1 x 100 ml vial /

price 80.

TGA approved

paracetamol

(Bristol)

Provas (Sami)




ampoule and vials.

Minutes for 253rd


296. -do- Ocian (WFI)

Each ampoule

contains

Water for

Injection

… 10ml

WFI

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4812 dated 04-

08-2015

MRP. Rs 5.00

for 1‟s per 10ml

MRP. Rs 250.00

for 25‟s per

10ml

MRP. Rs. 500

for 50‟s per 10

ml

MRP. Rs. 4.00

for 1‟s per 5ml

MRP. Rs.

100.00 for 25‟s

per 05 ml

MRP Rs. 200

for 50‟s per 05

ml

MRP Rs. 400

for 100‟s per 05

ml

MRP Rs. 150

for 50‟s per 03

ml

MRP Rs 300 for

100‟s per 03ml.

MHRA approved

WFI (TARO)

WFI (Epoch)




ampoule and vials.

297. -do- Gastid Injection

Each ampoule (2

ml) contains

Ranitidine HCl

… 50 mg

H2 Blocker

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4811 dated 04-

08-2015

MRP. Rs 110.56

for 05 Ampoule

MHRA approved

Ranitidine

(mercury

Pharma)

Zantac (GSK)




ampoule and vials.

298. -do- 3-D Injection

Each ampoule (1

ml) contains

Cholecalciferol

(Vit D3) ….

250,000 IU equal

to 5 mg

Vitamin

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4821 dated 04-

08-2015

MRP. Rs 165

for 01 Ampoule

Indrop D

(Neutro)




ampoule and vials.

Minutes for 253rd


299. -do- Nitid Injection

Each ampoule (2

ml) contains

Phenaramine

Maleate 50 mg

equivalent to

Pheniramine

Salicylate 45.4 mg

Arylakylamine

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4823 dated 04-

08-2015

MRP. Rs 500

for 50 x 02 ml

Ampoule

MRP Rs 1211

per 100 x 02 ml

International

availability not

confirmed

javil (Irza)




ampoule and vials.

300. -do- Phonac Injection

75 mg

Each ampoule (2

ml) contains

Diclofenac

Sodium USP 75

mg

Lignocaine HCl

20 mg

Phenylacetic acid/

anesthetic

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4828 dated 04-

08-2015

MRP Rs 140 per

05 Ampoule

International

availability not

confirmed

Afenac – plus

(ACMA

Laboratories

Pakistan Ltd)




ampoule and vials.

301. -do- Cloprel Injection

10 mg

Each ampoule (2

ml) contains

Metoclopramide

HCl … 10mg

Antidopaminergic

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4841 dated 04-

08-2015

MRP Rs 230 per

10 Ampoule

MRP Rs. 410

per 20 ampoules

MHRA approved

metoclopramide

(Ennogen)

Maxolon (GSK)




ampoule and vials.

302. -do- Dinate Injection

50 mg

Each ampoule (1

ml) contains

Dimenhydrinate

… 50mg

Form 5

Rs. 20,000/-

vide Dy. No.

4845 dated 04-

08-2015

MRP Rs 250 per

FDA approved

Dimenhydrinate

(APP Pharma)

Gravinate

(Searle)




ampoule and vials.

Minutes for 253rd


Antihistamine

(USP

Specification)

25 Ampoule

MRP Rs. 410

per 20 ampoules

303. -do- Lignox Injection

20 mg

Each ampoule (2

ml) contains

Lignocaine HCl

anhydrous … 20

mg

Local anesthetic

(BP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4845 dated 04-

08-2015

MRP Rs 187 per

100 Ampoules

MHRA approved

Lidocaine

Injection BP (B-

Braun germany)

Xylocaine

(Barrett)




ampoule and vials.

304. -do- Ferin Injection

100 mg

Each ampoule (5

ml) contains

Iron Sucrose

Complex … 100

mg

Haematinic

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4834 dated 04-

08-2015

MRP Rs 1831

per 05

Ampoules x 5ml

MHRA approved

Ferrologic 20

mg/ml (Fresenius

germany)

Bisleri (Sami)




ampoule and vials.

305. -do- M.B Vit Injection

500 mcg

Each ampoule (1

ml) contains

Mecobalamin…

500 mcg

Coenzyme Type

Vitamin B12

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4836 dated 04-

08-2015

MRP Rs 814 per

10 Ampoules

Methycobal

(Eisai, Japan)

Methycobal

(Hilton)




ampoule and vials.

EVALUATOR IV

Dry Powder Injection (Cephalosporin)

306. M/s Hamaz

Pharmaceuticals

(Pvt.) Ltd, 13-km,

Lutafabad, Bosan

Road, Multan

ADDITIONAL

SECTION: Dry

OPEROX

injection 1 g

Each Vials

contains

Cefoperazone as

Sodium (USP) eq

Form 5

Rs. 20,000/-

vide Dy. No.

4839 dated 04-

08-2015

FDA approved

Cefobid (Pfizer)

Aricef (Aries)

Approved

Minutes for 253rd


Powder Injection

(Cephalosporin) approved in 242

nd

meeting of CLB

to Cefoperazone

… 1 gm

Antibiotics

(Cephalosporin)

(USP

Specification)

MRP Rs 329.46

per 01 Vial

307. -do- OPEROX

injection 500 mg

Each Vial contains

Cefoperazone as

Sodium (USP) eq

to Cefoperazone

… 500 mg

Antibiotics

(Cephalosporin)

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4828 dated 04-

08-2015

MRP Rs 211.16

per 01 Vial

FDA approved

Cefobid (Pfizer)

Aricef (Aries)

Approved

308. -do- OPEROX

injection 250 mg

Each Vial contains

Cefoperazone as

Sodium (USP) eq

to Cefoperazone

… 250 mg

Antibiotics

(Cephalosporin)

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4818 dated 04-

08-2015

MRP Rs 114.40

per 01 Vial

FDA approved

Cefobid (Pfizer)

Aricef (Aries)

Approved

309. -do- Pyrocef injection 1

gm

Each Vial contains

Cefoperazone as

Sodium (USP) eq

to Cefoperazone

… 500 mg

Salbactum (USP)

as sodium … 500

mg

Antibiotics

(Cephalosporin)(B

eta Lactamase

Inhibitor)

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

48268 dated 04-

08-2015

MRP Rs 250 per

01 Vial

Magnex (Pfizer,

India)

Biped (Shawan)

Approved.

Minutes for 253rd


310. -do- Pyrocef injection 2

gm

Each Vial contains

Cefoperazone as

Sodium (USP) eq

to Cefoperazone

… 1 gm

Salbactum (USP)

as sodium … 1 gm

Antibiotics

(Cephalosporin)(B

eta Lactamase

Inhibitor)

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4807 dated 04-

08-2015

MRP Rs 350 per

01 Vial

Magnex (Pfizer,

India)

Biped (Shawan)

Approved as product is also

available in Japan.

311. -do- ON-CEF injection

500 mg

Each Vial contains

Cefipime as HCl

(USP) … 500 mg

Antibiotics

(Cephalosporin)

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4833 dated 04-

08-2015

MRP Rs 387.50

per 01 Vial

FDA approved

Maxipime

(Bristol ,USA)

Cefstar (Barrett)

Approved

312. -do- ON-CEF Injection

1 gm

Each Vial contains

Cefipime as HCl

(USP) … 1 gm

Antibiotics

(Cephalosporin)

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4814 dated 04-

08-2015

MRP Rs 730.08

per 01 Vial

FDA approved

Maxipime

(Bristol ,USA)

Cefstar (Barrett)

Approved

313. -do- Teraxone

Injection 250 mg

Each Vial contains

Ceftriaxone

Sodium equivalent

to Ceftriaxone

(USP) … 250 mg

Antibiotics

(Cephalosporin)

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4819 dated 04-

08-2015

MRP Rs 123.00

per 01 Vial

MHRA approved

Ceftriaxone

(Bowmed, ,UK)

Novosef

(Himont)

Approved

Minutes for 253rd


314. -do- Teraxone

Injection 500 mg

Each Vial contains

Ceftriaxone

Sodium equivalent

to Ceftriaxone

(USP) … 500 mg

Antibiotics

(Cephalosporin)

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4817 dated 04-

08-2015

MRP Rs 242.00

per 01 Vial

MHRA approved

Ceftriaxone

(Bowmed, ,UK)

Novosef

(Himont)

Approved

EVALUATOR IV

Cream/Ointment/Gel (General

315. M/s Hamaz

Pharmaceuticals

(Pvt.) Ltd, 13-km,

Lutafabad, Bosan

Road, Multan

ADDITIONAL

SECTION :

Cream/Ointment/

Gel (General) approved in 242

nd

meeting of CLB

Labicin Ointment

Each 1gm contains

i. Bacitracin Zinc

500 units

ii. Neomycin

Sulphate … 3.5

mg

iii. Polymyxin B

Sulphate 5000

units

iv. Lidocaine …

40 mg

Antibiotics / local

anesthetic

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4832 dated 04-

08-2015

Pack size

10 gm /Rs. 55

25 gm / Rs. 69

BACIMIX

(EPLA)




316. -do- Laphenor Cream

Each 20gm

contains

Diphenhydramine

… 1 % (0.2 gm)

Antihistamine

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4825 dated 04-

08-2015

Pack size

20 gm / Rs. 60

Benadryl Cream

(Canada)

Nil

(New dosage

form in Pakistan)

Deferred with direction to firm to

apply on prescribed Form 5D as it

is a new molecule.

317. -do- Laphenor

Ointment

Each 20gm

contains

Hydrocortisone…

1 % (0.2 gm)

Form 5

Rs. 20,000/-

vide Dy. No.

4829 dated 04-

08-2015

Pack size

FDA approved

Hydrocortisone

Ointment (Dow

pharma)

EKSALB (AGP)

Approved

Minutes for 253rd


Corticosteroid

(USP

Specification)

20 gm / Rs. 60

318. -do- Levacin Ointment

Each 1 gm

contains

Bacitracin Zinc

500 units

Neomycin

Sulphate … 3.5

mg

Polymyxin B

Sulphate 10000

units

Pramoxin HCl…

10 mg

Antibiotic Pain

reliever

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4820 dated 04-

08-2015

Pack size

15 gm / Rs. 80

FDA approved

Triple Antibiotic

Ointment

Not available

Deferred with direction to firm to

apply on prescribed Form 5D as it

is a new formulation to be

manufactured in Pakistan.

319. -do- Verocin Ointment

Each 10gm

contains

Mupirocin 2%

w/w

Broad Spectrum

Antibiotics

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4822 dated 04-

08-2015

Pack size

10 gm / Rs 100

15 gm / Rs. 160

5 gm / Rs. 75

FDA Approved

Bactroban (GSK,

Newzealand

Bactoderm

(Steifel)

Approved

320. -do- Lavisone Cream

Each 5 gm

contains

Fluticasone

Propionate ….

0.05%

Corticosteroid

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4809 dated 04-

08-2015

Pack size

10 gm / Rs 120

5 gm / Rs. 75

FDA approved

Fluticasone

Propionate

(Perrigo

newyork)

Cutivate (GSK)

Approved

Minutes for 253rd


321. -do- Lavotren Cream

Each 10 gm

contains

i. Erythromycin ..

2 % w/w

ii. Isotretinoin

0.5% w/w

Antibiotic &

retinoid

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4815 dated 04-

08-2015

Pack size

10 gm / Rs 264

MHRA approved

Isotrexin Gel

(Steifel,UK)

Isotrexin (GSK)

Deferred for clarification of

following points

i. The international

availability of the Isotrexin

is in gel form whereas firm

has proposed cream dosage

firm.

ii. The quantity of Isotretinoin

in Isotrexin Gel is 0.05%

w/w whereas firm has

proposed Isotretinoin 0.5%

w/w.

322. -do- Laviquin Cream

Each 20 gm

contains

Hydroquinone 4%

Skin Bleaches

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4813 dated 04-

08-2015

Pack size

20 gm / Rs 120

FDA approved

Clariderm DS

(USA)

Dermolite (Elite)

Approved

323. -do- Lavizole Topical

Cream

Each 10 gm

contains

Clotrimazole 1%

Anti Fungal

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

4835 dated 04-

08-2015

Pack size

10 gm / Rs 54

FDA approved

Canesten (Bayer)

Clotrim (Zafa)

Approved

324. -do- Vizole Cream

Each 10 gm

contains

i. Clotrimazole

1%

ii. Hydrocortisone

1%

Anti Fungal

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

48385 dated 04-

08-2015

Pack size

10 gm / Rs 80

TGA approved

Hydrozole (GSK)

Clozox H

(Shaigan)

Approved

Minutes for 253rd


EVALUATOR IV

M/s Decent Pharma, Islamabad

Oral Powder (General) Veterinary

325. M/s Decent

Pharma, Plot # 30,

Street No. SS-3,

National Industrial

Zone, Rawat,

Islamabad.

Additional section:

Oral Powder

(General)

Veterinary approved in 242

nd

meeting of Central

Licensing Board

Scada Water

Soluble Powder

Each 100 gm

contains

Ammonium

Chloride 30 gm

Aspirin 10 gm

Vitamin C 10 g

Di-Methionine 10

g

Vitamin A

150,000 IU

Sorbitol 5 gm

Analgesic &

Antipyretic

NSAID

Supplement

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

152 dated 07-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

Decontrolled

Gumbosol Water

Soluble Powder

(Westmont

Pharma)

Approved

326. -do- Decoc Water

Soluble Powder

Each 1 kg contains

Sulphadimidin

Sodium 225 gm

Diveridine HCl

62.5 gm

Vitamin K3.. 20.5

mg

Anticoccidial

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

119 dated 06-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

Decontrolled

Coxicide W/S

Powder. (Sana

Lab)

Approved

327. -do- Acelyte Water

Soluble Powder

Each 100 gm

contains

Aspirin 67 gm

Vitamin C 200 g

Sodium Citrate 0.7

gm

Calcium

Carbonate 50 g

Sodium Chloride

Form 5

Rs. 20,000/-

vide Dy. No.

115 dated 06-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

S-PRO-C W/S

POWDER

(NAWAL)

Approved

Minutes for 253rd


40 gm

Magnesium

Sulphate 40 gm

Analgesic &

Antipyretic

NSAID

Supplement

Veterinary

Preparation

(Manufacture

Specification)

Decontrolled

328. -do- Fresh All Water

Soluble Powder

Each kg contains

Furosemide 20 gm

Potassium

Chloride 4 gm

Calcium

Carbonate 45 g

Magnesium

Sulphate 35 gm

Maganese

Sulphate 1gm

Sodium Chloride

35 gm

Antiinfectives

minerals

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

116 dated 06-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

Decontrolled

Flush DM

Powder (D-

Maarson)

Approved

329. -do- Frusatop Water

Soluble Powder

Each kg contains

Furosemide B.P

20 gm

Calcium

Carbonate B.P 45

g

Sorbitol B.P 50

gm

Magnesium

Sulphate B.P

35gm

Form 5

Rs. 20,000/-

vide Dy. No.

143 dated 06-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

Decontrolled

Frusatol Powder

(Inshal)

Approved

Minutes for 253rd


Antiinfectives

minerals

(Manufacture

Specification)

330. -do- Segan Water

Soluble Powder

Each kg powder

contains

Trichlorphon 98%

Antiparasitic

(BP Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

121 dated 06-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

Decontrolled

Seguvan Powder

(Symans)

Approved

331. -do- Amporo-60 Water

Soluble Powder

Each kg contains

Amprolium HCl

600 gm

Anticoccidial

(BP Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

117 dated 06-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

Decontrolled

Amproshell-60%

powder (Inshal)

Approved

332. -do- Paracet Water

Soluble Powder

Each 100 gm

contains

Paracetamol 20

gm

Vitamin C 5 gm

Potassium

Carbonate 12.5

gm

Sodium

Bicarbonate 12.5

gm

Vitamin E 12.5

gm

Anticoccidial

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

1144 dated 07-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

Decontrolled

Para c powder

(Biogen)

Approved

Minutes for 253rd


333. -do- Wormidec Water

Soluble Powder

Each kg contains

Levamisole HCl

500 gm

Antielmintic

(BP Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

118 dated 07-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

Decontrolled

Anthiy Powder

(Marketed by

Seza Pharma)

Approved

334. -do- Aspidot Water

Soluble Powder

Each kg contains

Aspirin 67 gm

Vitamin C 200 gm

Analgesic and

antipyretic

NSAIDs

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

118 dated 07-

08-2015

Pack size of

100g, 500 g, 1

kg, 2.5kg, 5kg,

10kg & 25 kg

Decontrolled

SPC W/S Powder

(Cherished)

Approved

EVALUATOR IV

Oral Liquid (General) Veterinary

335. M/s Decent Pharma,

Plot # 30, Street No.

SS-3, National

Industrial Zone,

Rawat, Islamabad

Additional section:

Oral Liquid

(General)


nd

meeting of Central

Licensing Board.

Fendex Oral

Suspension

Each ml contains

Febendazole 100

mg

Antielmintic

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

146 dated 07-

08-2015

Pack size of

100ml, 150ml,

500 ml, 1 Liter,

2.5 lit, 5 lit, 10

lit

Decontrolled

UK authorized

veterinary

medicine

(PAnacur)

Fenbak 10%

(Attabak)

Approved

336. -do- Endex Oral

Suspension

Each ml contains

Triclabendazol

5%

Levamisole HCl

Form 5

Rs. 20,000/-

vide Dy. No.

148 dated 07-

08-2015

Triclapar oral

liquid (Grand

Pharma)

Approved with change of brand

name.

Minutes for 253rd


3.75%

Antielmintic

(Manufacture

Specification)

Pack size of

100ml, 150ml,

250ml, 500 ml,

1 Liter,

2.5 lit, 5 lit,

Decontrolled

337. -do- Endex DS Oral

Suspension

Each ml contains

Triclabendazol

12%

Levamisole HCl

7.5%

Antielmintic

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

148 dated 07-

08-2015

Pack size of

100ml, 200ml,

450 ml,500ml, 1

Liter,

2.5 lit, 5 lit, 10

L, 20 L

Decontrolled

Endonid 19.5%%

(Grand Pharma)

.

Approved with change of brand

name.

338. -do- Zonide Oral

Suspension

Each ml contains

Oxfendazole 22.65

mg

Oxyclozanide 62.5

mg

Cobalt as Sulphate

1.67 mg

Selenium as

Sodium Selenite

0.5 mg

Antielmintic

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

142 dated 07-

08-2015

Pack size of

100ml, 150ml,

500 ml, 1 Liter,

2.5 lit, 5 lit,

Decontrolled

Clozafen

(attabak)

Approved

339. -do- Levanide Oral

Suspension

Each ml contains

Levamisole HCl

B.P 1.5 gm

Oxyclozanide B.P

3.0 gm

Antielmintic

Form 5

Rs. 20,000/-

vide Dy. No.

149 dated 07-

08-2015

Pack size of

100ml, 150ml,

500 ml, 1 Liter,

2 lit, 5 lit,

Floxy-L (Leo

biocare)

Approved

Minutes for 253rd


(Manufacture

Specification)

Decontrolled

340. -do- Oxadec Oral

Suspension

Each ml contains

Oxfendazole

B.P2.265%

Antielmintic

(BP Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

150 dated 07-

08-2015

Pack size of

100ml, 150ml,

250 ml, 500 ml,

1 Liter,

2.5 lit, 5 lit,

Decontrolled

Oxzole (Nawal)

Approved

341. -do- Cyper 10 Pour On

Oral Suspension

Each ml contains

Cypermethrin 100

mg

Antiparasitic

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

150 dated 07-

08-2015

Pack size of

100ml, 150ml,

250 ml, 500 ml,

1 Liter,

2.5 lit, 5 lit,

Decontrolled

Ecofleece (Prix)

Approved

342. -do- Trimec Oral

Suspension

Each 100ml

contains

Triclabendazol 5

gm

Ivermectin 100 mg

Antielmintic

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

154 dated 07-

08-2015

Pack size of

100ml, 150ml,

250 ml, 500 ml,

1 Liter,

2.5 lit, 5 lit,

Decontrolled

Endoplus 5.1%

(Biolabs)

Approved

Minutes for 253rd


343. -do- Trimec DS Oral

Suspension

Each 100ml

contains

Triclabendazol 12

gm

Ivermectin 200 mg

Antielmintic

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

141 dated 07-

08-2015

Pack size of

100ml, 150ml,

250 ml, 500 ml,

1 Liter,

2.5 lit, 5 lit,

Decontrolled

Endoplus

12.2%(Biolabs)

Approved

344. -do- Albadec Super

Oral Suspension

Each Liter

contains

Albendazole B.P

12.50%

Antielmintic

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

147 dated 07-

08-2015

Pack size of

100ml, 150ml,

250 ml, 500 ml,

1 Liter,

2.5 lit, 5 lit,

Decontrolled

ALBAZOLE

(Nawan)

Approved

EVALUATOR IV

-

Oral Powder (Penicillin) Veterinary

345. M/s Decent Pharma,

Plot # 30, Street No.

SS-3, National

Industrial Zone,

Rawat, Islamabad

Additional section,

Oral Powder

(Penicillin)


nd

meeting of Central

Licensing Board.

Augmencil Water

Soluble Powder

Each 1000gm

contains

Amoxycillin

Trihydrate 160 gm

Colistin Sulphate

40 gm

Clavulanic acid 40

gm

Dextrose

anhydrous

Penicillin/antibioti

cs

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

145 dated 07-

08-2015

Pack size of

100gm, 500

gm, 1kg,

5kg, 10kg &

20kg

Decontrolled

Caltin W/S

Powder (D-

maarson)

Approved

Minutes for 253rd


346. -do- Colab Water

Soluble Powder

Each 1000 gm

contains

Colistin Sulphate

500 MIU

Lincomycin HCl

50gm

moxycillin

Trihydrate 100 gm

Bromhexin HCl 5

gm


cs

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

124 dated 07-

08-2015

Pack size of

100gm, 500

gm, 1kg,

5kg, 10kg &

20kg

Decontrolled

Moxin-L WSP

(Attabak)

Approved

347. -do- ASLE Water

Soluble Powder

Each gram

contains

Amoxycillin as

Trihydrate B.P

200 mg

Spectinomycin

2HCl B.P 80mg

Lincomycin B.P

80 mg

Vitamin E Acetate

B.P 30 mg


cs

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

127 dated 07-

08-2015

Pack size of

50gm, 100gm,

500 gm, 1kg,

5kg, 10kg &

20kg

Decontrolled

Lincamox –s

(Breeze)

Approved

348. -do- Linkomox Water

Soluble Powder

Each 100 gram

contains

Amoxycillin as

Trihydrate B.P

100 g

Lincomycin as

HCl B.P 50 g

Streptomycin

2HCl B.P 50gm


cs

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

128 dated 07-

08-2015

Pack size of

100gm, 250gm,

500 gm, 1kg, 2.5

kg,

5kg, 10kg &

25kg

Decontrolled

Moxapect

(Biogen)

Approved

Minutes for 253rd


349. -do- Euromox-50

Water Soluble

Powder

Each 100 gram

contains

Amoxycillin

Trihydrate 50 g

Colistin Sulphate

50 MIU

Dextrose

anhydrous QS 100

gm


cs

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

125 dated 07-

08-2015

Pack size of

50gm , 100gm,

500 gm, 1kg,

5kg, 10kg &

25kg

Decontrolled

Amox C (D-

maarson )

Approved

350. -do- Ascot Water

Soluble Powder

Each kg contains

Amoxycillin

Trihydrate 200 g

Colistin Sulphate

800 MIU

Dextrose

anhydrous QS

1000 gm


cs

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

122 dated 07-

08-2015

Pack size of

50gm , 100gm,

500 gm, 1kg,

5kg, 10kg &

25kg

Decontrolled

Polimox W/S

Powder (Biogen)

Approved

351. -do- Lyzomox Water

Soluble Powder

Each kg contains

Amoxycillin (as

Trihydrate) B.P

50gm

Lyzosyme HCl 10

gm

Guaifenesin 35

gm

Penicillin

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

129 dated 07-

08-2015

Pack size of

50gm , 100gm,

500 gm, 1kg,

5kg, 10kg &

25kg

Decontrolled

Amoxy Add

(Hassan

Brothers)

Approved

Minutes for 253rd


352. -do- Potencil Water

Soluble Powder

Each kg contains

i. Amoxycillin

Trihydrate 150

g

ii. Colistin

Sulphate 500

MIU

iii. Dextrose

anhydrous QS

1000 gm


cs

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

123 dated 07-

08-2015

Pack size of

50gm , 100gm,

500 gm, 1kg,

5kg, 10kg &

25kg

Decontrolled

Amoxybar-c

(Baariq)

Approved

353. -do- Neo AC Water

Soluble Powder

Each kg contains

Amoxycillin as

Trihydrate B.P

100 g

Colistin Sulphate

B.P 50 gm

Neomycin

Sulphate USP 200

gm


cs

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

126 dated 07-

08-2015

Pack size of

100gm, 500

gm, 1kg,

5kg, 10kg &

20kg

Decontrolled

Amoxy-N W/S

Powder (Hira)

Approved

354. -do- Betamox Water

Soluble Powder

Each kg contains

Amoxycillin as

Trihydrate B.P

230 g

Colistin Sulphate

B.P 1000 MIU

Dextrose

anhydrous QS

1000 gm


cs

(manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

130 dated 07-

08-2015

Pack size of

50gm , 100gm,

500 gm, 1kg,

5kg, 10kg &

25kg

Decontrolled

Pentamox

(biogen)

Approved

Minutes for 253rd


EVALUATOR IV

M/s Alza Pharmaceuticals (Formerly M/s Alshife Trust Eye Hospital), Rawalpindi

Cream/Ointment/Gel (General)

355. M/s Alza

Pharmaceuticals

(Formerly M/s

Alshife Trust Eye

Hospital), Jhelum

Road, Rawalpindi.

Additional section:

Cream/Ointment/

Gel (General) approved in 241

st

meeting of Central

Licensing Board.

Benasil Cream 1%

Each gram

contains

Terbinafine USP

… 10 mg

Antifungal

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5241 dated 07-

08-2015

Pack size of

10gm as per

SRO

MHRA approved

Terbinafine HCl

1% (Niche, UK)

Lamisil

(Novartis)

Approved

356. -do- Methyroid Cream

0.1%

Each gram

contains

Methylprednisolo

ne Aceponate 1mg

Glucocorticoids

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5233 dated 07-

08-2015

Pack size of

10gm as per

SRO

TGA approved

Advantan Cream

0.1% (CSL,

Australia)

Advantan

(Bayer)

Approved

357. -do- Silza Cream

Each gram

contains Silver

Sulfadiazine 10

mg

Sulfonamide

Antibiotics

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5251 dated 07-

08-2015

Pack size of

15gm as per

SRO

FDA approved

SSD (Dr. Reddys

LA, USA)

Quench

(Ferozsons)

Approved

358. -do- Hyclozole Cream

Each gram

contains

Hydrocortisone 10

mg

Clotrimazole 10

mg

Antifungal/

Corticosteroid

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5229 dated 07-

08-2015

Pack size of

10gm as per

SRO

MHRA approved

Canesten HC

cream (Bayer)

Hydrozole (GSK)

Approved

Minutes for 253rd


359. -do- Hirsunil Cream

11.5%

Each gram

contains

Eflornithine (as

HCl) 115mg

Antiprotozoal

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5231 dated 07-

08-2015

Pack size of

15gm as per

SRO

MHRA approved

Vaniqa (Almirall,

Barcelona)

Depilus (Atco)

Approved

360. -do- Erytrexin Gel

Each gram

contains

Erythromycin

(USP) 20 mg

Isotretenoin (BP)

0.5 mg

Antibacterial/Anti

acne

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5226 dated 07-

08-2015

Pack size of

10gm as per

SRO

MHRA approved

Isotrexin Gel

(GSK)

Tretocin (Derma

Techno)

Approved

361. -do- Taclimus

Ointment

Each gram

contains

Tacrolimus

Immunomodulator

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5223 dated 07-

08-2015

Pack size of

10gm as per

SRO

MHRA approved

Protopic 0.03%

Ointment

(Astellas,

Netherland)

Crolimus (Valor)

Deferred as product is under

review and refered to the

Licensing Division for

requirement of manufacturing

area for immunomodulatory

products.

362. -do- Mucin F Ointment

Each gram

contains

Fluticasone

Propionate 0.5 mg

Mupirocin 20 mg

Corticosteroid/anti

bacterial

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5224 dated 07-

08-2015

Pack size of

5gm as per SRO

Cutivate M

(GSK) not

available in

Pakistan but india

Deferred for confirmation of

approval by reference regulatory

authorities

Minutes for 253rd


363. -do- Calbetol Ointment

Each gram

contains

Calcipotriol

anhydrous 0.05

mg

Betamethasone (as

Dipropionate) 0.5

mg

Corticosteroid/Vit

D analogue

(Manufacture

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5250 dated 07-

08-2015

Pack size of

10gm as per

SRO

MHRA approved

(Dalbecal by

Teva,UK)

Calcibet (Valor)

Approved

364. -do- Mucin Ointment

Each gram

contains

Mupirocin 20 mg

USP

Antibacterial

(USP

Specification)

Form 5

Rs. 20,000/-

vide Dy. No.

5234 dated 07-

08-2015

Pack size of

15gm as per

SRO

MHRA approved

Mupirocin

ointment

Bactroban (GSK)

Approved

EVALUATOR I M/s Ardin Pharmaceuticals, Karachi


365. M/s Ardin

Pharmaceuticals,

plot No. 56 Sector

27, Korangi

Industrial area,

Karachi.

Cream/Ointment/G

el (General)

approved in 240th

meeting of CLB

Gentarin Cream

0.3%

Each gram

contains

Gentamicin

Sulphate 0.3%

Antibiotic

USP

Specifications

Form-5

23-06-2015

diary No 302.

Rs20,000

As per SRO/10

Gm Pack

Not confirmed

Not confirmed

Deferred for clarification as

firm has changed the

formulation from 0.3% to

0.1%.

366. -do- Ardic Cream 2%

Each gram

contains Fusidic

acid….. 20mg

Antibiotic

B.P

Specifications

Form-5

23-06-2015

diary No 309.

Rs20,000

As per SRO/15

Gm Pack

Fucidin 2% By M/s Leo

MHRA

Fucirog 2% by M/s

Wisdom

Approved

Minutes for 253rd


367. -do- Ardefenac Gel 1%

Each gram

contains

Diclofenac

diethylamine eq to

Diclofenac

Sodium….. 10mg

Analgesic

B.P Specifications

Form-5

23-06-2015

diary No 309.

Rs20,000

As per SRO/15

Gm Pack

FDA approved Voltral

Gel

Voltral (Novartis)

Approved

368. -do- Sulfadin Cream

1%

Each gram

contains:- Silver

Sulfadiazine….10

mg

Antibacterial

Manufacturer‟s

Specifications

Form-5

23-06-2015

diary No 311.

Rs20,000

As per SRO/25

Gm Pack

FDA Silvadene Cream

1%

Burnasil Cream 1% by

M/s Bloom

Approved

369. -do- Neocin Cream

Each gram

contains

betamethasone as

valerate….1mg

Neomycin

sulphate …. 5mg

Corticosteride/Ant

ibacterial

Manufacturer‟s

Specifications

Form-5

23-06-2015

diary No 304.

Rs20,000

As per SRO/10

Gm Pack

Not confirmed

Betnovate-N by M/s

GSK

Deferred for confirmation

of approval by reference

regulatory authorities

370. -do- Dermazin Gel

Each gram

contains

Lignocaine HCl

…. 20mg

Local Anesthetic

B.P Specifications

Form-5

23-06-2015

diary No 303.

Rs20,000

As per SRO/15

Gm Pack

FDA Lidocaine 2%

Xylocaine gel 2% by

M/s Barret Hodgson

Approved with the change of

name.

371. -do- Clomidin 1%

Cream

Each gram

contains

Clotrimazole….10

mg

Antifungal

B.P Specifications

Form-5

23-06-2015

diary No 310.

Rs20,000

As per SRO/10

Gm Pack

FDA Clotrimazole 1%

Clotrim 1% by M/s

Zafa.

Approved

Minutes for 253rd


372. -do- Polydin Ointment

Each gram

contains

Polymyxin B

Sulphate….10,000

Units Bacitracin

Zinc …500Units

Antifungal

USP

Specifications

Form-5

23-06-2015

diary No 307.

Rs20,000

As per SRO/20

Gm Pack

FDA Bacitracin &

Polymyxin by M/s

Akorn

Polyfax by M/s GSK

Approved

373. -do- Pain-Go Balm

Each 100 gram

contains

Methyl

Salicylate….15gm

Menthol ….10gm

Analgesic

B.P Specifications

Form-5

23-06-2015

diary No 306.

Rs20,000

As per SRO/50

Gm Pack

Not confirmed

Not confirmed

Deferred for clarification as

firm has changed the

formulation from 0.3% to

0.1%.

374. -do- Burnil Cream

Each gram

contains

Euflavine(Acriflav

in) …1mg

Antiseptic

Manufacturer‟s

Specifications

Form-5

23-06-2015

diary No 305.

Rs20,000

As per SRO/30

Gm Pack

MHRA approved

Burnol by M/s Abbott.

Approved with the change of

name.

Capsule (General)

375. M/s Ardin

Pharmaceuticals,

plot No. 56 Sector

27, Korangi

Industrial area,

Karachi.

Capsule (General)

approved in 240th

meeting of CLB

Esoprazole

Capsule 40mg

Each capsule

contains enteric

coated

Esomeprazole

Magnesium pellets

eq.to

Esomeprazole

40mg

Proton Pump

Inhibitor

Manufacturer

Specifications

Form-5

23-06-2015

diary No 315.

Rs20,000

As per SRO

Source M/s

Vision Pharma,

Islamabad.

FDA, Nexium by M/s

Astrazeneca

Esso 40mg by Shaigan

Approved

376. -do- Ardefenac

Capsule 100mg

Each capsule

contains

Diclofenac

Sodium SR

pellets eq.to

Diclofenac

Form-5

23-06-2015

diary No 318.

Rs20,000

As per SRO

Source M/s

Vision Pharma,

Islamabad.

Diclomax Retard

100mg capsule by M/s

Galen Ltd

Dicloyan-S capsules by

M/s Roryan, Pharma

Deferred for confirmation

of approval by reference


Minutes for 253rd


Sodium 100mg

NSAIDs

BP Spec

377. -do- Azin Capsule

250mg

Each capsule

contains

Azithromycin

Dihydrate eq. to

Azithromycin

250mg

Macrolide

USP

Specifications

Form-5

23-06-2015

diary No 321.

Rs20,000

As per SRO

Zithromax capsule

250mg by M/s Pfizer

UK

Acim capsule 250mg by

M/s Fynk Pharma

Approved

378. -do- Lincodin Capsule

500mg

Each capsule

contains

Lincomycin HCl

eq. to Lincomycin

500mg

Antibiotic

USP

Specifications

Form-5

23-06-2015

diary No 317.

Rs20,000

As per SRO

FDA Lincomycin

500mg capsule by M/s

Pharmacia

Lincocin 500mg by M/s

Pfizer

Approved

379. -do- Celedin Capsule

200mg

Each capsule

contains

Celecoxib 200mg

NSAID

USP

Specifications

Form-5

23-06-2015

diary No 319.

Rs20,000

As per SRO

Celebrex capsule 200mg

by M/s Pfizer UK

Cobix 200mg capsule by

M/s EG Pharma

Approved

380. -do- Ardicam Capsule

20mg

Each capsule

contains

Piroxicam 20mg

NSAID

B.P Specifications

Form-5

23-06-2015

diary No 318.

Rs20,000

As per SRO

FDA Feldene 20mg by

M/s Pfizer

Feldene 20mg Cap by

M/s Pfizer

Approved

381. -do- Ardium Capsule

2mg

Each capsule

contains

Loperamide 2mg

USP

Specifications

Form-5

23-06-2015

diary No 318.

Rs20,000

As per SRO

FDA,Imodium 2mg by

M/s J & J

Imodium 2mg by M/s

Janssen

Approved

Minutes for 253rd


M/s Soma Laboratories, has been shifted from residential area of Saman Abad Lahore to their new site located at Plot # 43-D,

Sundar Industrial Estate Raiwind Road Lahore, in compliance of the SRO 470/98 dated 15-05-1998 of the Drugs Act 1976.

Central Licesning Board in its 241st meeting held on 15-05-2015 approved the grant/shifting of their DML No. 000225

(Formulation).

The already licensed sections of the firm in the previous site in residential area i.e. Sachet (General) and Tablet (General) of

the firm have been shifted / re-granted to new location and in addition, firm also developed new facility for Capsule General

section.

Status of the firm for previous registered products of the firm is not clear. However, firm has reported to apply for transfer of

eight (8) previous products in R-V section. In addition to these, firm has also applied for registration of following new products

in Sachet general and tablets general sections. It is submitted for consideration of RB for registration of new products in shifted

/ re-granted section.

382. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Sachet General)

shifted.

Someta

Sachet


Dioctahedralsmectite……3gm

Antidiarrheal, Gastro-intestinal

protectant

Form-5

Dy. No: 4391

dated09-07-15

Rs.20000/- (As

per PRC)

1x30‟s

Smecta by Atco

Available in

France.

Approved in

250th

meeting.

Deferred for

confirmation of

registration status in

shifted sections as firm

has already applied for

transfer of registrations

to new site and for

clarification of

followings:

Firm using no

excepient in

formulation.

Finished product specs

not provided.

Sign of QC manger and

production manger

seems different on

submitted commitment.

383. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Sachet General)

Calcinate

Sachet


Calcium

Gluconate………578mg

Calcium Lactate…………422mg

Calcium carbonate………327mg

Vit C …………………….500mg

Calcium salt

Form-5

Dy. No: 4392

dated 09-07-15

Rs.20000/- (As

per SRO)

1x10‟s

Lachida by M/s

Zephyr

Pharmatec.

International

availability not

provided.

Deferred for

confirmation of





to new site and for

clarification of

followings:

Me too not correct as it

also contain calcium

pentothenate 1000mg.

International

availability not

confirm.

Finished product specs

not provided.


production manger

Evaluator II

Minutes for 253rd


seems different on

submitted commitment

384. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Sachet General)

Sodalime

Sachet


Sodium

Bicarbonate……1.716gm

Sodium

Citrate…………0.613gm

Citric Acid……………. 0.702gm

Tartaric Acid…………. 0.858gm

Antacid & Anti-flatulent

Form-5

Dy. No: 4393

dated.

09-07-15

Rs.20000/- (As

per PRC)

1x10‟s, 1x100‟s

Sodazaf by m/s

zafa

pharmaceuticals.

International

availability not

confirmed.

Deferred for

confirmation of





to new site and for

clarification of

followings:


production manger

seems different on


International

availability needs to be

confirmed.

Testing method given

for “sodium citrate and

citric acid oral

solution”.

Tablet (General) shifted

385. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Tablet General)

Dicophen 75

Tablet


Diclifenac Potassium

NSAID

Form-5

Dy. No: 4372

dated.

09-07-15

Rs.20000/- (As

per SRO)

2x10‟s,

100‟s Jar

ACHEX 75mg by

m/s Wise

Pharmaceuticals.

International

availability not

confirmed.

Deferred for

confirmation of





to new site and for

clarification of

following:

International

availability not

confirmed.

Label claim not correct.

Formulation contains

sweetening agents and

flavours but method

outline shows it is film

coated tablets.

Master formulation

contains diclofenac

sodium instead of

diclofenac potassium.

Finished products specs

not provided.

Minutes for 253rd


386. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Tablet General)

Sofloxin 500

Tablet


Ciprofloxacin

(HCl)……599.99mg

Fluoroquinolones (Antibiotics)

Form-5

Dy. No: 4373

dated.

09-07-15

Rs.20000/- (As

per SRO) 10‟s

AMPROX 500

mg by m/s

ROGEN

Pharmaceuticals.

USFDA, MHRA

Deferred for

confirmation of





to new site and for

clarification of

following:

Coating material

contains methylene

chloride.


production manger

seems different on


Firm has copied and

pasted the formulation

in products at serial no.

5, 6, 7.

387. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Tablet General)

Sefenic Forte

Tablet


Mefenamic Acid……599.99mg

NSAID

Form-5

Dy. No: 4380

dated.

09-07-15

Rs.20000/- (As

per SRO) 100‟s

Ponstan forte by

m/s Pfizer

laboratories.

MHRA

Deferred for

confirmation of





to new site and for

clarification of

following:

Quantity of active not

as per Me too.

Manufacturing out line

shows it as film coated

tablets.


production manger

seems different on


Firm has copied and



5, 6, 7.

388. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Tablet General)

Gastracil

Tablet


Magnesium

Trisilicate….599.99mg

Antacid

Form-5

Dy. No: 4379

dated.

09-07-15

Rs.20000/- (As

per SRO)

1000‟s

AMTRI 500mg by

m/s Mian

Brothers.

International

availability not

confirmed. In

MHRA and

USFDA it exist in

combination with

Deferred for

confirmation of





to new site and for

clarification of

following:

Minutes for 253rd


Aluminium

Hydroxide.


as per Me too.

Manufacturing out line

shows it as film coated

tablets.


production manger

seems different on


Firm has copied and



5, 6, 7.

389. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Tablet General)

Levofac

Tablet


Levofloxacin…….500mg

Antacid

Form-5

Dy. No: 4374

dated.

09-07-15

Rs.20000/- (As

per SRO) 10‟s

Aksolox 500mg

by m/s Akson

Pharmaceuticals.

USFDA, MHRA

Deferred for

confirmation of





to new site and for

clarification of

following:

Quantity of active is

256.15 mg instead of

500 mg eq to Base.

No binder, lubricant or

gliding agent etc given.


required.

Coating material

contains methylene

chloride.

Firm has copied and



8, 12.

390. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Tablet General)

Dicolin 50

Tablet


Diclofenac Sodium…….50mg

NSAID

Form-5

Dy. No: 4375

dated.

09-07-15

Rs.20000/- (As

per SRO)

2x10‟s Blister

Jar 100 Tablet

Accred 50mg

Tablets by m/s

Albro Pharma.

MHRA, USFDA

Deferred for

confirmation of





to new site and for

clarification of

following:

It exist as extended/

delayed release or

gastro-resistant but firm

has provided flavouring

and sweetening agents

that are used chewable

tablets. It needs

Minutes for 253rd


confirmation.

Label claim not clear.


required.

Sign of QC manger

and production manger

seems different on


391. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Tablet General)

Sofloxin

Tablet


Ciprofloxacin HCl

Monohydrate…. 750mg


Form-5

Dy. No: 4376

dated.

09-07-15

Rs.20000/- (As

per SRO) 10‟s

Amesure 750mg

by m/s Medisure

Laboratories.

MHRA

Deferred for

confirmation of





to new site and for

clarification of

following:


justified.

Firm is using

methylene chloride for

coating.


required.


production manger

seems different on


392. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Tablet General)

Clith 500

Tablet


Clarithromycin…….599.99mg

Macrolide Antibiotic

(USP Specs.)

Form-5

Dy. No: 4381

dated.

09-07-15

Rs.20000/- (As

per SRO)

1x10‟s

Claritek by m/s

Getz Pharma.

MHRA, USFDA

Deferred for

confirmation of





to new site and for

clarification of

following:


Firm has copied and



5, 6, 7.

No coating material

given.


production manger

seems different on


393. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Levofac 250

Tablet


Levofloxacin…….250mg

Form-5

Dy. No: 4382

dated.

09-07-15

Aksolox 500mg

by m/s Akson

Pharmaceuticals.

USFDA, MHRA

Deferred for

confirmation of



Minutes for 253rd


Raiwind Road

Lahore.

(Tablet General)


Rs.20000/- (As

per SRO) 10‟s



to new site and for

clarification of

following:

No binder, lubricant or

gliding agent etc given.


required.

Coating material

contains methylene

chloride.


production manger

seems different on


Firm has copied and



8, 12.

394. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Tablet General)

Ib-Fen

Tablet


Ibuprofen…..400mg

NSAID

Form-5

Dy. No: 4384

dated.

09-07-15

Rs.20000/- (As

per PRC) 100‟s

Actifen by m/s

Glaxosmithkline.

MHRA

Deferred for

confirmation of





to new site and for

clarification of

following:


Firm has mentioned

sodium Ibupofen

Dihydrate as active.


production manger

seems different on


Capsule (General)-New Section

395. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Azitho

Capsule


Azithromycin…… 500mg


Form-5

Dy. No: 4377

dated.

09-07-15

Rs.20000/- (As

per SRO) 6‟s

Azomax of M/s

Novartis Pharma

Deferred for

clarification of

following Azomax

500mg exist in tablets

form.

Firm using no

excepient in

formulation and has

mentioned that no

excepient required.


justified.

Outline method of

manufacturing shows it

Minutes for 253rd


soft gelatin capsule


production manger

seems different on


Strength active and in

active material is not

provided.

Capsule shell size not

provided.

International

availability need to be

confirmed.

396. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Azitho

Capsule


Azithromycin…… 250mg


(Specs USP 32)

Form-5

Dy. No: 4371

dated.

09-07-15

Rs.20000/- (As

per SRO) 12‟s

Azomax of M/s

Novartis Pharma

MHRA

Firm using no

excepient in

formulation and has

mentioned that no

excepient required.


justified.

Outline method of




production manger

seems different on




provided.


provided.

397. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Sotran 500

Capsule


Tranexamic Acid……527.44

Anti-Fibrinolytic Agent

Form-5

Dy. No: 4385

dated.

09-07-15

Rs.20000/- (As

per SRO) 20‟s

Hixamic of M/s

Himont

Chemicals.

It exist as 650mg

tablets in USFDA

and 500mg tablets

in MHRA. It exist

as capsule in

japanes

Pharmacopiea but

strength not clear.

Deferred for

clarification of

following

Quantity of active need

justification.

Outline method of




production manger

seems different on




provided.


provided.

Product specification is

not provided.

Minutes for 253rd


398. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Sodox

Capsule


Doxycycline (hyclate)

…..100.44mg

Tetracycline Antibiotic

(USP Specs.)

Form-5

Dy. No: 4378

dated.

09-07-15

Rs.20000/- (As

per SRO)

10x10‟s

D-Clin of M/s

Caylex

Pharmaceuticals

(Pvt) Ltd.

MHRA

Deferred for

clarification of

following

Outline method of




production manger

seems different on


Quantity of active

needs justification

399. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Ezole-40

Capsule


Esomeprazole……40mg

Anti-Ulcer

USP-32 Specs

Form-5

Dy. No: 4383

dated.

09-07-15

Rs.20000/- (As

per SRO) 2x7‟s

Omega of M/s

Ferozsons

Laboratoies Ltd.

USFDA

Deferred for

clarification of

following

Outline method of




production manger

seems different on




provided.


provided.

Quantity of active

needs justification

Source of pellets not

provided.

From master

formulation its not

clear that active

material is in powder

form or pellet form.

400. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Ezole-20

Capsule


Esomeprazole……20mg

Anti-Ulcer

USP-32 Specs

Form-5

Dy. No: 4386

dated.

09-07-15

Rs.20000/- (As

per SRO) 14‟s

Omega of M/s

Ferozsons

Laboratoies Ltd.

(omega contains

omeprazole but

me too exists.)

USFDA

Deferred for

clarification of

following

Composition and

specification of each

ingredient per unit not

provided.

Proposed shelf life

three years.

Outline method of




production manger

seems different on


Minutes for 253rd




provided.

Details of water

processing facility are

required.


provided.

Quantity of active

needs justification


provided.

Master formulation

contains active as pellet

and excipients as

powder that is not

justified.

Although Me too

available in Pakistan

but Omega contain

Omeprazole instead of

esomeprazole.

401. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Eprazole-20

Capsule


Omperazole……20mg

Anti-Ulcer

USP-32 Specs

Form-5

Dy. No: 4387

dated.

09-07-15

Rs.20000/- (As

per SRO) 14‟s

Acezole

Of M/s T.G.

Pharma

Deferred for

clarification of

following

Outline method of




production manger

seems different on




provided.

Details of water


required.


provided.

Quantity of active

needs justification


provided.

From master

formulation its not

clear that active


form or pellet form

Minutes for 253rd


402. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Eprazole-40

Capsule


Omperazole……40mg

Anti-Ulcer

USP-32 Specs

Form-5

Dy. No: 4388

dated.

09-07-15

Rs.20000/- (As

per SRO) 14‟s

Acezole

Of M/s T.G.

Pharma

Deferred for

clarification of

following

Composition and

specification of each

ingredient per unit not

provided.

Proposed shelf life

three years.

Outline method of




production manger

seems different on




provided.

Details of water


required.


provided.

Quantity of active

needs justification


provided.

From master

formulation its not

clear that active


form or pellet form

403. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Andol

Capsule


Indomethacin…….27.44

NSAID

USP-32 Specs

Form-5

Dy. No: 4389

dated.

09-07-15

Rs.20000/- (As

per SRO)

10x50‟s

Jar (500‟s)

Methacid

Of M/s Unexo

Labs International

availability not

provided.

Deferred for

clarification of

following

Quantity of active need

justification.

Outline method of




production manger

seems different on




provided.


provided.

Minutes for 253rd



not provided.

404. M/s Soma

Laboratories, Plot

# 43-D, Sundar

Industrial Estate

Raiwind Road

Lahore.

(Capsule

General)

Vetinol

Capsule


Vitamin A ……100mg=50000

I.U

NSAID

Form-5

Dy. No: 4390

dated.

09-07-15

Rs.20000/- (As

per SRO)

2x10‟s

Jar 100

ACE-BEX by M/s

Schazoo

Laboratories

International

availability not

provided

Mee too not

correct

Deferred for

clarification of

following

Me too not correct

International

availability needs to be

confirmed.

Firm using 100% active

without any excepient.


production manger

seems different on



provided.


not provided.

Evaluator II

Deferred cases of Additional sections of 251st meeting

M/s Bio-Labs (Pvt) Ltd. Islamabad

405. M/s Bio-Labs

(Pvt) Ltd. Plot

No.145 Industrial

Triangle, Kahuta

Road, Islamabad.

Oral Powder

Penicillin approved in 241

st

meeting of CLB

dated 15-05-2015.

BIO Lincoxyspectin ws powder.

Water soluble Powder.

Each 100gm contains:

Amoxicillin Trihydrate…..10gm

Lincomycin (HCl)…………5gm

Spectinomycin dihydrochloride

pentahydrate eq to

spectionmycin……5.0gm

(Antibacterial)

Manufacturer Specs.

Form-5

Dy. No: 290

Dated. 28-05-

2015

Rs.20,000/-

100gm, 500gm,

1000gm, 2kg,

3kg, 5kg/ As

per SRO

Salinobak wsp

Of M/s

Attabak

Pharmaceutical

Approved

406. -do- BIO-Amoxyllin 20% ws powder.



Amoxcilline Trihydrate

equivalent to

amoxicilline….20gm

(Antibiotec)

BP Specs.

Form-5

Dy. No: 292

Dated. 28-05-

2015

Rs.20,000/-

100gm, 500gm,

1000gm, 2kg,

3kg, 5kg/ As

per SRO

S.B Ormaox-

20wsp of M/s S.B

pharma

Islamabad.

Approved

407. -do- BIO-Amoxyllin 70% powder.


Each 100gm contains.

Amoxicillin trihydrate…..80gm

Equivalent 70gm of Amoxicillin

Form-5

Dy. No: 289

Dated. 28-05-

2015

Rs.20,000/-

Primox 70% of

M/s Prix Pharma Approved

Minutes for 253rd


base

(Anti bacterial amoxicillin

trihydrate is moderate spectrum,

bacteriolytic)

B.P Specs.

100gm, 500gm,

1000gm, 2kg,

3kg, 5kg/ As

per SRO

408. -do- BIO Lincocilline ws powder.


Each 1gm contains.

Amoxycillin

Trihydrate…..200mg

Lincomycin (HCl)……..88mg

Spectinomycin Dihydrochloride

Pentahydrate equivalent to

Spectinomycin……88mg

Vitamin-E………..30mg

(All the active one‟s are

Antibacterial)

Bio-Labs Specs.

Form-5

Dy. No: 232

Dated. 06-05-

2015

Rs.20,000/-

100gm, 500gm,

1000gm, 2kg,

3kg, 5kg/ As

per SRO

Lincamox-S of

M/s Breeze

pharma

Approved

409. M/s Vetz

Pharmaceuticals,

private Limited,

S.I.T.E Kotri

Sindh

Oral Powder

(Vet) approved in

241st meeting of

CLB held on 15-

05-2015.

Sulprolium

Each Kg contains.

Amprolium B.P…200gm

Sulfaquinoxaline (B.P)…200gm

Vit k (B.P)…..2gm

Antibactrial

(Manufacturer specs)

Form-5

Dy. No: 365

dated. 19-06-

2015

20000/- dated

30-06-2015

Decontrolled

Pack of 100gm,

250gm,500gm,

1 kg, 5Kg,

25Kg

Vety Flush by

Leads

Pharmaceutical

Approved

410. M/s GMP

Pharmaceuticals

Lahore.

Oral dry powder

Suspension

(Cephalosporin)

in 241st meeting

of CLB

Gedoxim 40mg suspension

Each 5ml contain:

Cefpodoxime (as

proxitil)…..40mg

Cephalosporin Antibiotics

(USP specs)

Form-5

Dy. No: 2372

dated. 09-12-14

20000/- dated

08-12-2014

Rs. (As Per

SRO) Pack of 1

x 50ml

Quink Susp by

Wilshire Lab

Lahore.

Approved

Minutes for 253rd


Evaluator I

M/s Kohinoor Industries Sahiwal


411. M/s Kohinoor

Industries

Sahiwal, Plot #

159-160/B Small

Industrial Estate,

Sahiwal.

Cream

/Ointment/ Gel

(General) approved in 241

st

meeting of CLB.

Cloocin Cream 2%

Each gram contains:-

Clindamycin Phosphate eq. to

Clindamycin….20mg

Antibiotic

USP Specifications

Form-5

29-07-2015

diary No 4697.

Rs20,000

As per SRO/ 40

gm tube

Dalacin Cream

UK, by M/s Pfizer

Clind-V by M/s

Highnoon

Approved

412. –

-

-do- Traxin-E Gel


Isotretenoin….0.5mg (0.05%)

Erythromycin….20mg (2%)

Retnoid & Macrolide

Manufacturer‟s Specifications

Form-5

29-07-2015

diary No 4696.

Rs20,000

As per SRO/ 10

gm tube

Isotrexin Gel UK,

by M/s Stockley

Tretocin by M/s

Derma Techno

Approved

413. -do- Gynaeclov-V Cream 2%


Clotrimazole B.P….20mg (2%)

Antifungal

B.P Specifications

Form-5

29-07-2015

diary No 4689.

Rs20,000

As per SRO/ 35

gm tube

Canasten Cream

UK, by M/s Bayer

Fresno Cream by

M/s Biogen

Approved

414. -do- Fusi-Topical Cream 2%


Fusidic Acid….20mg (2%)

Antibacterial

B.P Specifications

Form-5

29-07-2015

diary No 4694.

Rs20,000

As per SRO/ 15

gm tube

Fucidin Cream

UK, by M/s Leo

Fusimin Cream by

M/s Sharooq

Approved

415. -do- Regain Ointment 0.005%


Calcipotriol….50mcg (0.005%)

Antipsoriatics


Form-5

29-07-2015

diary No 4691.

Rs20,000

As per SRO/ 30

gm tube

Calcipotriol

Ointment UK, by

M/s Sandoz

Dervit by M/s

Nabiqasim

.

Approved with the

change of name

416. -do- Hydrozone Cream 2.5%


Hydrocortisone Acetate eq. to

Hydrocortisone ….25mg (2.5%)

Corticosteride

B.P Specifications

Form-5

29-07-2015

diary No 4698.

Rs20,000

As per SRO/ 15

gm tube

Emo Cort Cream

Canada, by M/s

GSK

Hydrocort Cream

by M/s Atco

Approved

Minutes for 253rd


417. -do- Derma Care Cream 0.05%

Each gram contains:- Clobetasol

Propionate ….0.5mg (0.05%)

Corticosteride

B.P Specifications

Form-5

29-07-2015

diary No 4701.

Rs20,000

As per SRO/ 10

gm tube

Dermovate Cream

UK, by M/s GSK

Clobevate Cream

by M/s Stiefel

Approved

418. -do- Safe Burn Cream 1%

Each gram contains:- Silver

Sulfadiazine USP ….10mg (1%)

Anti-microbial

USP Specifications

Form-5

29-07-2015

diary No 4695.

Rs20,000

As per SRO/ 20

gm tube

Thermazine

Cream USA, by

M/s The

pharmanetwork

Quench Cream by

M/s Ferozsons

Approved with the

change of name

419. -do- Betnocare Cream 0.1%


Betamethasone as Valerate eq. to

betamethasone….1mg (0.1%)

Corticosteride

B.P Specifications

Form-5

29-07-2015

diary No 4702.

Rs20,000

As per SRO/ 10

gm tube

Betnovate Cream

UK, by M/s The

GSK

Betnovate Cream

by M/s GSK

Approved

420. -do- Flex-E Gel 1.16%

Each gram contains:- Diclofenac

diethylammonium….11.6mg

(1.16%) eq to Diclofenac Sodium

10 mg

NSAID

B.P Specifications

Form-5

29-07-2015

diary No 4690.

Rs20,000

As per SRO/ 20

gm tube

Voltral Emul Gel

UK, by M/s The

Novartis

Voltral Emul Gel

Cream by M/s

Novartis

Approved

Sachet (General)

421. M/s Kohinoor

Industries

Sahiwal, Plot

# 159-160/B

Small

Industrial

Estate,

Sahiwal.

Sachet

(General) approved in

241st meeting

of CLB.

Komizol Sachet

Each sachet contains:-

Omeprazole...40mg Sodium

bicarbonate............1680mg

PPI & Antacid


Form-5

29-07-2015

diary No 4692.

Rs20,000

As per SRO/

Box of 10

sachet

Zegerid Powder

for oral

suspension,

USA, by M/s

Santarus

Risek Insta by M/s

Getz

Panel vide

inspection vide

dated 08-09-2014,

new section

recommended.

Deferred as the

formulation is under

review.

Minutes for 253rd


422. -do- Mobegel Sachet


Mebeverine HCl….135mg

Ispaghula Husk…3.5g

Bulk forming laxative &

antispasmodic agent


Form-5

04-08-2015

diary No 4878.

Rs20,000

As per SRO/

Box of 10

sachet

Fybogel

Mebverine, UK,

by M/s Reckit

Benckiser

Colonil Fibro by

M/s Nabiqasim

Approved

423. -do- ORK Sachet

Each sachet contains:- Glucose

Anhydrous….13.5g Sodium

Chloride…2.6g Potassium

Chloride….1.5g Trisodium citrate

dehydrate…2.9gm

Oral Rehydration Therapy

B.P Specifications

Form-5

29-07-2015

diary No 4703.

Rs20,000

As per SRO/

Box of 07

sachet

WHO

recommended

formulation

OEM Sachet by

M/s Indus

recommended.

Approved

424. -do- Komizol Sachet 20


Omeprazole...20mg Sodium

bicarbonate............1680mg

PPI & Antacid


Form-5

29-07-2015

diary No 4693.

Rs20,000

As per SRO/

Box of 10

sachet

Zegerid Powder

for oral

suspension,

USA, by M/s

Santarus

Risek Insta by M/s

Getz

Panel vide

inspection vide

dated 08-09-2014,

new section

recommended.

Deferred as the


review

425. -do- Bonita Sachet


Strontium Ranelate...2g

Treatment of osteoporosis


Form-5

29-07-2015

diary No 4699.

Rs20,000

As per SRO/

Box of 07

sachet

The firm has

provided the

reference of france

which require to

be confirmed

Onita by M/s

Pharmevo

Approved

426. -do- Grafort Sachet


Dioctahedral Smectite...3g

Mucoprotective Agent


Form-5

04-08-2015

diary No 4879.

Rs20,000

As per SRO/

Box of 01

sachet

The product is

approved in 250th

meeting of RB.

Smecta by M/s

Acto

Approved

Minutes for 253rd


427. -do- Acecol Sachet 200mg


Acetylcysteine...2g

Mucolytics


Form-5

04-08-2015

diary No 4882.

Rs20,000

As per SRO/

Box of 30

sachet

The firm has

provided the

reference of south

Africa and

Switzerland which

require to be

confirmed

mucolator by M/s

Abbott

Deferred as the


review

428. -do- Fomy-C Sachet


Fosfomycin as trometamol...3g

Antibacterial


Form-5

04-08-2015

diary No 4881.

Rs20,000

As per SRO/

Box of 1 sachet

Munorol

(USFDA)

Monurol by M/s

Angelini

Approved

429. -

-

-do- MKS Pediatric Sachet


Montelukast as Sodium...4mg

Leukotriene Receptor Antagonist


Form-5

04-08-2015

diary No 4880.

Rs20,000

As per SRO/

Box of 1 sachet

Singulair

Paediatric Sachet,

USA

Singulair

Paediatric Sachet

by M/s OBS

Approved

430. -do- Movease Sachet


Polyethylene glycol

3350.....13.125g Sodium

Chloride…0.3507g Sodium

Bicarbonate….0.1785g

Potassium Chloride….0.0466g

Laxative and electrolyte


Form-5

29-07-2015

diary No 4700.

Rs20,000

As per SRO/

Box of 10

sachet

Movicol Sachet,

UK

Movcol by M/s

Genix Pharma

Approved with the

change of name.

Minutes for 253rd


EVALUATOR III M/s Ras Pharmaceuticals, Multan

Additional section – Veterinary

(Oral powder general & Vitamin premix-Veterinary)

431. M/s Ras

Pharmaceuticals,

Lahore Road,

Multan.

(Oral powder

general & Vitamin

premix-

Veterinary)

approved in 241st

meeting of CLB

BURSARENAL Oral

Powder

Each 100 gm contains

Potassium citrate…..3.60g

Sodium citrtate….2.50g

Nicotinamide….0.70g

Menadione….0.025g

Vitamin B1……0.007g

Vitamin B2….0.004g

Vitamin C…0.300g

Vitamin & Minerals

Manufacturer

Form-5

Dy. No 5120

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Selectromin Oral

Powder of Sanna

Labs

Approved

432. -do- CA SUPER Oral Powder


Acetylsalicylic

acid…..22.2g

Ascorbic acid….666gm

Analgesic & Vitamin

Manufacturer

Form-5

Dy. No 5119

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Acevit-C Oral

Powder of A &K

Pharma

Approved

433. -do- ICE-VIT Oral Powder


Potassium chloride…4gm

Sodium chloride….3gm

Biotin…0.1g

Calcium D

pantothenate….10.2gm

Folic acid….0.850gm

Vitamin A….2025000IU

Vitamin

D3…..1850000IU

Vitamin E…5500IU

Vitamin K3…5000IU

Vitamin B1….4.150gm


Vitamin B12…20mcg

Form-5

Dy. No 5135

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Selectromin

powder of sanna

labs

Deferred for

confirmation of Me too

status.

Minutes for 253rd


Vitamin C….1.750gm

Vitamin & Mineral

Manufacturer

434. -do- ONEVIT Oral Powder


Oxytetraycline

HCL….10gm

Neomycin

Sulphate…10gm

Vitamin A….75000IU

Vitamin D3….50000IU

Vitamin E….0.25gm

Vitamin B 1….0.1gm


Vitamin…B6….0.12gm

Vitamin B12…0.75g

Vitamin C….50gm

Calcium

Pantopatheante…10gm

Folic acid….0.030gm

Nicotinic acid…0.15gm

dL-Methionine….3gm

L-Lysine….5gm

Antibiotic & Multivitamin

Manufacturer

Form-5

Dy. No 5140

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

NO-BAC Oral

powder of sanna

Labs

Approved

435. -do-

(Oral powder

general Antibiotic-

Veterinary)

COCCI Super Oral

Powder


Sulphadimidine

Sodium…..80gm

Diaveridine….8gm

Vitamin K3….0.8gm

Antibacterial

Manufacturer

Form-5

Dy. No 5144

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Super-Coxin

Powder of

Intervac Lahore

Approved

Minutes for 253rd


436. AMOXY-150 Oral

Powder


Amoxycilline

trihydrate…..15gm

Colistin

Sulphate…50MIU

Antibacterial

Manufacturer

Form-5

Dy. No

5143dated 12-

08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

ATC-Water

soluble powder of

Sasna Labs

Rejected as firm does

not have dedicated

penicillin section, as

required for

manufacturing of

penicillin product.

437. -do- LC-100 Oral Powder


Lincomycin as

HCL….10gm

Colistin

sulphate…80,000,000IU

Antibacterial

Manufacturer

Form-5

Dy. No 5136

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

LINCOL Powder

of Intervac

Approved

438. -do- LICOGROW-44 Oral

Powder


Lincomycin HCL….44

Antibacterial

Manufacturer

Form-5

Dy. No 5134

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Licofas-44 of

Intervac

Approved

439. -do- NEOCIN-S Oral Powder


Neomycin

Sulphate…..72gm

Antibacterial

Manufacturer

Form-5

Dy. No 5122

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Neomar 72

Powder of Zumar

Pharma

Approved

440. -do- SUPER GROW Oral

Powder


Procaine penicillin….1.2g

Streptomycin

sulphate….3.6gm

Form-5

Dy. No 5132

dated 12-08-15

20000/-

Ultragrow of

Intervac


not have dedicated


required for

manufacturing of

penicillin product.

Minutes for 253rd


Zinc bacitracin….5.2gm

Colistin sulphate….6MIU

Antibacterial

Manufacturer

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

441. -do- AMCOLINC-S Oral

Powder


Amoxicilline

trihydrate….20gm

Lincomycin

base….8.8gm

Spectinomycin

base…8.8gm

Vitamin E acetate…..3gm

Antibacterial and Vitamin

Manufacturer

Form-5

Dy. No 5140

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

LINCAMOX-S of

ICI


not have dedicated


required for

manufacturing of

penicillin product.

442. -do- SUPER CNC-Oral

Powder


Chlortetracycline

HCL…..8gm

Neomycin

Sulphate…7gm

Colistin sulphate….0.4gm

Antibiotic

Manufacturer

Form-5

Dy. No 5141

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

CNC-200 Powder

of Epla Labs

Approved

443. -do- AF-200 Oral Powder


Amprolium…..20gm

Furltadon……20gm

Antibacterial

Manufacturer

Form-5

Dy. No 5143

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Sancox of Sana

Labs

Approved

444. -do- T-FON 100 Oral Powder


Trichlorfon….98gm

Silicon dioxide…..2g

Antibacterial

Manufacturer

Form-5

Dy. No 5142

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Santrifon 100 W/S

powder of Sanna

Labs.

Approved

Minutes for 253rd


445. -do- RESPICARE Oral

Powder


Tylosin tartrate….5g

Erythromycin

thioicynate….6g

Furaltadon HCL….14g

Antibacterial

Manufacturer

Form-5

Dy. No 5126

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Respinil Powder

of Sanna Labs


of brand name.

446. -do- SPIROX-10 Oral Powder


Spiramycin….10gm

Doxycycline

HCL…10gm

Bromhexine HCL….2gm

Antibiotic

Manufacturer

Form-5

Dy. No 5138

dated 12-08-15

20000/-

Decontrolled/

100gm, 500gm,

1kg, 2.5kg, 5kg

& 25 kg

Me too status

needs

confirmation

Deferred for

confirmation of me too

status.

(Oral liquid general Antibiotic- Veterinary)

447. M/s Ras

Pharmaceuticals,

Lahore Road,

Multan.

(Oral liquid

general Antibiotic-

Veterinary)

approved in 241st

meeting of CLB

NAFLOXIN-23 Oral

Liquid


Florfenicol……23g

Antibacterial

Manufacturer

Form-5

Dy. No 5123

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Neflox solution of

Selmore

Approved

448. -do- FD-20 Oral liquid


Florfenical CPV…..20g

Doxycycline HCL….20g

Antibacterial

Manufacturer

Form-5

Dy. No 5124

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Not provided Deferred for


status.

Minutes for 253rd


449. -do- FLORDOX Oral Liquid


Florfenicol CPV…..10g

Doxycycline HCL…..10g

Antibacterial

Manufacturer

Form-5

Dy. No 5127

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Deferred for


status.

450. -do-

ENICIN-20 Oral Liquid


Enrofloxacin….20gm

Antibacterial

Manufacturer

Form-5

Dy. No 5137

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Senrox-20 oral

Liquid of Sanna

Labs

Approved

451. -do- WARM-NIL Plus Oral

Liquid


Levamisole HCl….1.5gm

Oxyclozanide…3.0g

Cobalt

sulphate….0.382gm

Antibacterial/ Dewormer

Form-5

Dy. No 5125

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Deferred for


status.

452. -do- TETZOLE Oral Liquid


Toltrazuril….2.5gm

Vitamin K3…..0.3gm

Antibacterial

Manufacturer

Form-5

Dy. No 5128

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Toltra Liquid of

Intervac

Deferred for

clarification of


submitted.

Minutes for 253rd


453. -do- OXFEN Oral Liquid


Oxfendazole….2.265gm

Anthelmintic

Manufacturer

Form-5

Dy. No 5130

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Oxanazole

suspension of

Sana Labs

Approved

454. -do- IVAGIN Oral Liquid


Milk Thistle (tandrazied

extract)…..210mg

Choline

chloride….200mg

Sorbitol….1000mg

Inositol….1500mg

Lysine….3000mg

Biotin ….150mg

Vitamin E….2000mg

Vitamin & Minerals

Manufacturer

Form-5

Dy. No 5133

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Deferred for


status.

455. -do- MYCOSTOP Oral Liquid


Tylosin tartrate….10gm

Doxycycline

HCL…20gm

Colistin

sulphate…500MIU

Bromhexine HCL…5gm

Antibacterial

Manufacturer

Form-5

Dy. No 5131

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Tylo-biotec liquid

of Grand Pharma

Approved

456. -do- CINARAS Oral Liquid


Cinoxin…..0.75g

Sulphamethoxy

pyridazine…..0.75g

Sulphamethazine…….5g

Trimethoprim…..2.50gm

Antibacterial

Manufacturer

Form-5

Dy. No 5117

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

JFCINA of Jfrine

Karachi

Approved

Minutes for 253rd


457. -do- NEF-10 Oral Liquid


Florfenicol……10g

Antibacterial

Manufacturer

Form-5

Dy. No 5118

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Florobak oral

liquid of Attabak

Approved

458. -do- NOR-TS Oral Liquid


Norfloxacin…..5g

Sulphamethoxypyridazine

…..5g

Trimethoprim….1g

Phenylbutazone…1.2g

Bomhexine…..0.5g

Antibacterial

Manufacturer

Form-5

Dy. No 5129

dated 12-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Me too status

submitted needs

confirmation.

Deferred for


status.

459. -do- NOVAFORT Oral

Solution

Each ml contains:

Novaminsulfon…..40mg

Etileferin……0.2mg

Calcium

gluconate….100mg

Magnesium

gluconate…..10mg

Sodium

Salicylate……7mg

Nicotinamide….0.3mg

Caffiene ….10mg

Boric acid…..10mg

Antibacterial

Manufacturer

Form-5

Dy. No

27-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

NOVAFAS of

Intervac

Approved

460. -do- CARDISOL Oral

Solution

L-Carnitine….500mg

Vitamin B6

(PyrodoxineHCL)….50m

g

Vitanmin B12 ….1.5mg

Nicotinamide….100mg

Calpan….100mg

Sorbitol….10g

dl-Methionine…1000mg

Form-5

Dy. No

27-08-15

20000/-

Decontrolled/

100ml, 500ml,

1L, 2.5 L , 5 L

& 25 L

Deferred for


status.

Minutes for 253rd


L-Arginine…..300mg

L-Citruline….200mg

L-Glycine….200mg

L-Aspartic Acid…150mg

L-Lysine…..100mg

L-Glutamic acid…150mg

L-Ornithine….200mg

(Multi Vitamin)

Manufacturer

Case No. 05: Grant of Registration for Routine Cases (Local)

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition


Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

International

status in

reference drug

agencies /

authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Remarks

461. M/s Safe

Pharmaceuticals, (

Pvt) Limited, Plot

No. 20, Sector 6-

B, North Karachi

Industrial area,

Karachi

VOLIDO Injection

Each 2ml contains:

Diclofenac

Sodium…..75mg

Lidocaine HCL….20mg

NSAID/ Local Anesthetic

Manufacture

Form-5

20000/-

As per SRO/

5‟sx2ml & 10‟s

x 2ml

Not found/ not

provided

Dinopen Injection

of Centaury

Pharmaceuticals

Inspection of the

firm was carried

out on 28-08-14

by the area FID

and GMP is rated

as GOOD

Deferred for

confirmation of



462. -do- MECOLIN Capsules


Mecobalamin…..500mcg

Co-enzyme type vitamin

B12

Form-5

8000 dated 10-

05-10

12000 dated

04-07-13

As per SRO/

2x10‟s

Not found/ Not

provided

Mecomars of Max

Pharma

Deferred for

confirmation of



Minutes for 253rd


463. -do- I-TOSE Capsules


Iron-III Hydroxide

polymaltose….100mg

Anti-anemic

Manufacturer

Form-5

8000 dated 10-

05-10

12000 dated

04-07-13

As per SRO/

1x10‟s

Ferry capsules of

Tabros Pharma

Approved

464. -do- DIC-POT Capsules

100mg SR


Diclofenac

potassium…100mg

NSAID

Manufacturer

Form-5

8000 dated 10-

05-10

12000 dated

04-07-13

As per SRO/

2x10‟s

Not found/ Not

provided

Ariflam SR

capsules of Aeries

Pharma

Deferred for

confirmation of



465. -do- ZEROX Capsules 250mg


Azithromycin as

dihydrate…..250mg

Antibiotic

Manufacturer

Form-5

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

2x10‟s

Azithromycin

Capsules 250mg

(BNF)

AZZA Capsules

of Genome

Approved

466. -do- ZEROX Capsules 500mg


Azithromycin as

dihydrate…..500mg

Antibiotic

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

6‟s

Not found/ Not

provided

Azogen capsules

of Rogen Pharma

Deferred for

clarification by firm in

light of 250th

Registration Board

meeting decision

467. -do- FAYNEEC Capsules

50mg


Diclofenac

sodium….50mg

NSAID

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

10‟s

Not found/ Not

provided

Dicloras of Rasco

Pharma

Deferred for

confirmation of



Minutes for 253rd


468. -do- SAFOXICAM Capsules

10mg


Piroxicam…..10mg

NSAID

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

2x10‟s

Feldene Capsules

of Pfizer (MHRA)

Exican capsules of

Novamed pharma

Approved

469. -do- LEVO Capsules 250mg


Levofloxacin…..250mg

Fluoroquinolone

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

1x10‟s

Not found/ Not

provided

E-Lev capsules of

English Pharma

Deferred for

confirmation of



470. -do- LEVO Capsules 500mg


Levofloxacin…..500mg

Fluoroquinolone

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

1x10‟s

Not found/ Not

provided

E-Lev capsules of

English Pharma

Deferred for

confirmation of



471. -do- CIPRO Capsules 500mg


Ciprofloxacin…..500mg

Fluoroquinolone

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

1x10‟s

Not found/ Not

provided

CIPFAS of

Genome

Deferred for

confirmation of



Minutes for 253rd


472. -do- CIPRO Capsules 250 mg


Ciprofloxacin…..250mg

Fluoroquinolone

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

1x10‟s

Not found/ Not

provided

CIPFAS of

Genome

Deferred for

confirmation of



473. -do- SITAPRAM Tablets


contains:

Escitalopram as

oxalate….10mg

Antidepressant

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

1x14‟s

Cipralex tabltes of

Lundbeck

Citalem tablets of

Lundbeck

Approved

474. -do- SITAPRAM Tablets


contains:

Escitalopram as

oxalate….20mg

Antidepressant

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

1x14‟s

Cipralex tabltes of

Lundbeck

Citalem tablets of

Lundbeck

Approved

475. -do- HYRSET Tablets 15mg


Midazolam

meleate…..15mg

Sedative & Hypnotic

Manufacturer

Form-5

Dy. No

8000 dated 17-

02-10

12000 dated

22-05-13

As per SRO/

5‟s

Not found/ Not

provided

Not found/ Not

provided

Deferred for

confirmation of



and me too status

Minutes for 253rd


476. -do- TORINDA-O Tablet


contains:

Tinidazole….600mg

Ofloxacin……200mg

Quinolone, Amoebicide

Manufacturer

Form 5

Dy. No: 1522

R-II dated 03-

08-2010

8,000/- dated

10-05-10

12,000/- dated

04-07-13

As Per

SRO/10‟s

Not found/ Not

provided

Not found/ Not

provided

Deferred for

confirmation of



and me too status

477. -do- TORINDA-N Tablet


contains:

Tinidazole….600mg

Norfloxacin……400mg


Manufacturer

Form 5

Dy. No: 1519

R-II dated 03-

08-2010

8,000/- dated

10-05-10

12,000/- dated

04-07-13

As Per

SRO/10‟s

Not found/ Not

provided

Not found/ Not

provided

Deferred for

confirmation of



and me too status

478. -do- TORINDA-C Tablet


contains:

Tinidazole….600mg

Ciprofloxacin………500

mg


Manufacturer

Form 5

Dy. No: 1519

R-II dated 03-

08-2010

8,000/- dated

10-05-10

12,000/- dated

04-07-13

As Per

SRO/10‟s

Not found/ Not

provided

Not found/ Not

provided

Deferred for

confirmation of



and me too status

479. M/s Berlex Lab

International

Multan.

MOXIL Tablets 400mg


contains:

Moxifloxacin as

HCL….400mg

Fluoroquinolone

Manufacturer

Form-5

Dy. No 4794

dated 03-06-10

8000 dated 01-

06-10

12000 dated

03-09-13

Rs 250/- Pack

of 1x10‟s

Avelox of Bayer

(MHRA)

Avelox of Bayer

Deferred as firm has

stopped production for

renovation and area

FID has identified

number of

shortcoimngs in

inspection conducted

on 28.05.2015, which

need rectification.

Minutes for 253rd


480. -do- SOLEX Tablets 10mg


conatins:

Montelukast as

sodium……10mg

Leukotriene receptor

antagonist

Manufacturer

Form-5

Dy. No 4794

dated 03-06-10

8000 dated 01-

06-10

12000 dated

03-09-13

Rs 375/- Pack

of 1x10‟s

Montelukast

Sodium Tablets of

Roxane Labs Inc

Aerokast of

Barrett Hodgsen

Karachi



renovation and area

FID has identified

number of

shortcoimngs in


on 28.05.2015, which

need rectification.

481. -do- Acne Capsules 100mg


Minocycline as

Hydrochloride…………

100mg

Tetracycline

Manufacturer

Form-5

03/06/2010, Dy

No: 4800

8000+12000/-

Rs 70/- Pack of

1x10‟s

Minocin Capsules

of Onset

Dermatologics Inc

Minocin of Valor

Pharma

Rawalpindi



renovation and area

FID has identified

number of

shortcoimngs in


on 28.05.2015, which

need rectification.

482. -do- Solex Chewable Tablet

5mg

Each chewable tablet

contains Montelukast as

sodium …….5mg

Antiasthmatic

Manufacturer

Form-5

03/06/2010, Dy

No: 4795

8000+12000/-

Rs 275/- Pack

of 1x10‟s

Montelukast

Sodium Chewable

Tablets of Roxane

Labs Inc

Aerokast of

Barrett Hodgsen

Karachi



renovation and area

FID has identified

number of

shortcoimngs in


on 28.05.2015, which

need rectification.

483. -do- Clarix Tablets 500mg


contains

Clarithromycin……

500mg

Antibiotic

BP

Form-5

03/06/2010, Dy

No: 4798

8000+12000/-

Rs 500/- Pack

of 1x10‟s

Biaxin of Abbvie

Klaricid of Abbott

Karachi



renovation and area

FID has identified

number of

shortcoimngs in


on 28.05.2015, which

need rectification.

484. -do- Clarix Tablets 250mg


contains

Clarithromycin……

250mg

Form-5

03/06/2010, Dy

No: 4801

8000+12000/-

Biaxin of Abbvie

Klaricid of Abbott

Karachi



renovation and area

FID has identified

number of

shortcoimngs in


Minutes for 253rd


Antibiotic

BP

Rs 300/- Pack

of 1x10‟s

on 28.05.2015, which

need rectification.

485. -do- Synlex Tablet 550mg


contains Naproxen

Sodium……550mg

Propionic acid

BP

Form-5

03/06/2010, Dy

No: 4793

8000+12000/-

Rs 200/- Pack

of 2x10‟s

Anaprox DS of

Genetech USA.

Dephlog of

StandPharm

Lahore.



renovation and area

FID has identified

number of

shortcoimngs in


on 28.05.2015, which

need rectification.

486. M/s OBS Pakistan

(Pvt) Limited

Karachi

I-BON Tablets

Each film coated

contains:

Ibandronate

Sodium…2.5mg

Postmenopausal

osteoporosis

Manufacturer

Form-5

22-12-2010,

Dy No: 165

8000+12000/-

Rs 100/- per

tablet/ Pack of

30‟s

Roche

Iband of Caraway

Pharma

Inspection of the

firm was carried

out on 08-04-15

by the panel of

inspectors and

recommended the

renewal of DML

Approved

487. -do- I-BON Tablets

Each film coated

contains:

Ibandronate as

Sodium…150mg

Postmenopausal

osteoporosis

Manufacturer

Form-5

22-12-2010,

Dy No: 166

8000+12000/-

Rs 3000/- per

tablet/ Pack of

1‟s

BONIVA

(USFDA)

Iband of Caraway

Pharma

Approved

488. -do- POLY-OBS Capsules

Each soft gelatin capsule

contains:

Zinc as

sulphate….22.5mg

Vitamin E…..30mg

Vitamin C….500mg

Folic acid….150mcg

Vitamin B1…15mg

Vitamin B2….15mg

Nicotinamide….100mg

Vitamin B6….20mg

Vitamin B12….12mcg

Pantothenic acid….20mg

Form-5

22-12-2010,

Dy No: 164

8000+12000/-

Rs 20/- per

capsule/ Pack

of 10‟s

Not found/ not

provided

Me too status

needs

confirmation

Deferred for


status.

Minutes for 253rd


Vitamin B complex

Manufacturer

489. M/s Innvotek

Pharmaceuticals,

35 Industrial

Estate Triangle,

Kahuta Road

Islamabad

MALGO Tablets


Artemether….20mg

Lumefantrine….120mg

Anti-malarial

Manufacturer

Form-5

Dy. No 2055

dated 09-06-11

8000 dated 14-

06-11

12000 dated

23-07-13

Rs. 320/- Pack

of 16‟s

WHO

recommended

formulation

A-mether of Rasco

Pharma Lahore

GMP report dated

15.07.2015

satisfactory

Approved

490. -do- IMOX Tablets


contains:

Moxifloxacin HCL eq. to

Moxifloxacin…..400mg

Antibacterial

Manufacturer

Form-5

Dy. No 2054

dated 09-06-11

8000 dated 14-

06-11

12000 dated

23-07-13

Rs. 680/- Pack

of 5‟s

Avelox of Bayer

Avelox of Bayer

Karachi

GMP report dated

15.07.2015

satisfactory

Approved

491. -do- D-PAL Tablets


contains:

Diclofenac

Potassium….75mg

NSAID

Manufacturer

Form-5

Dy. No 2053

dated 09-06-11

8000 dated 14-

06-11

12000 dated

23-07-13

Rs. 160/- Pack

of 10x2‟s

Not found in

reference drug

agencies

Antiflam Tablets

of Wilshire

GMP report dated

15.07.2015

satisfactory

Deferred for

confirmation of



Minutes for 253rd


492. -do- D-PAL Tablets


contains:

Diclofenac

Potassium...….50mg

NSAID

Manufacturer

Form-5

Dy. No 2052

dated 09-06-11

8000 dated 14-

06-11

12000 dated

23-07-13

Rs. 130/- Pack

of 10x2‟s

Diclofenac

Potassium tablets

of Actavis

Antiflam of

Wilshire

GMP report dated

15.07.2015

satisfactory

Approved

493. M/s Getz Pharma

(Pvt) Limited, 29-

30-Sector 27,

Korangi,

Industrial Area,

Karachi

TREVIAMET XR Tablets

Each extended release

tablet contains:

Sitagliptin as Phosphate

monohydrate….50mg

Metformin HCL…500mg

DPP-4 & Biguanide

Manufacturer

Form-5D

Dy. No : 1804

dated 14-12-12

50000 dated

12-12-12

Rs. 101/- per

tablet/ Pack of

14‟s & 30‟s

Janumet XR

(USFDA)

Laboratory scale

scientifically rational

stability data as per

requirements decided

in the 251st meeting of

Registration Board is

required

494. -do- TREVIAMET XR Tablets


tablet contains:


monohydrate….100mg

Metformin

HCL…1000mg

DPP-4 & Biguanide

Manufacturer

Form-5D

Dy. No 1803

dated 14-12-12

50000 dated

12-12-12

Rs. 169 /- per

tablet/ Pack of

14‟s & 30‟s

Janumet XR

(USFDA)

Laboratory scale






required

495. -do- TREVIAMET XR Tablets


tablet contains:


monohydrate….50mg

Metformin

HCL…1000mg

DPP-4 & Biguanide

Manufacturer

Form-5D

Dy. No :1805

dated 14-12-12

50000 dated

12-12-12

Rs. 102 /- per

tablet/ Pack of

14‟s & 30‟s

Janumet XR

(USFDA)

Laboratory scale






required

Minutes for 253rd


496. -do- TREVIAMET Tablets


contains:


monohydrate….50mg

Metformin HCL…850mg

DPP-4 & Biguanide

Manufacturer

Form-5D

Dy. No :67

dated 06-08-11

15000 dated

04-08-11

35000 dated

30-07-13

Rs. 102 /- per

tablet/ Pack of

14‟s & 30‟s

Janumet (EMA)

Laboratory scale






required

497. -do- GLIX Tablet


contains:

Saxagliptin as

HCL…..2.5mg

DPP-4 Inhibitor

Manufacturer

Form-5D

Dy. No :

15000 dated

21-02-11

5000 dated 30-

07-13

Rs. 90 /- per

tablet/ Pack of

14‟s & 20‟s

Onglyza (USFDA) Deferred for

clarification as firm has

submitted application

of Form-5D, however

the submitted fee is

20000/-

498. -do- GLIX Tablet


contains:

Saxagliptin as

HCL…..5mg

DPP-4 Inhibitor

Manufacturer

Form-5D

Dy. No :

15000 dated

21-02-11

5000 dated 30-

07-13

Rs. 150 /- per

tablet/ Pack of

14‟s & 20‟s

Onglyza (USFDA) Firm has submitted

application of Form-

5D, however the

submitted fee is

20000/-

499. -do- GLIX-M Tablet


contains:

Saxagliptin as

HCL…..5mg

Metformin HCL

(Extended

release)…..500mg

DPP-4 Inhibitor

Manufacturer

Form-5D

Dy. No : 620

dated 07-03-11

15000 dated

21-02-11

35000 dated

30-07-13

Rs. 151.50 /-

per tablet/ Pack

of 14‟s & 20‟s

KOMBIGLYZE

XR (USFDA)

Laboratory scale






required

Minutes for 253rd




contains:

Saxagliptin as

HCL…..2.5mg

Metformin HCL

(Extended

release)…..1000mg

DPP-4 Inhibitor

Manufacturer

Form-5D

Dy. No : 619

dated 07-03-11

15000 dated

21-02-11

35000 dated

30-07-13

Rs. 93 /- per

tablet/ Pack of

14‟s & 20‟s

Kombiglyze XR

(USFDA)

Laboratory scale






required



contains:

Saxagliptin as

HCL…..5mg

Metformin HCL

(Extended

release)…..1000mg

DPP-4 Inhibitor

Manufacturer

Form-5D

Dy. No : 623

dated 07-03-11

15000 dated

21-02-11

35000 dated

30-07-13

Rs. 153.50 /-

per tablet/ Pack

of 14‟s & 20‟s

Kombiglyze XR

(USFD A)

Laboratory scale






required

502. M/s Otsuka

Pakistan, F/4-9,

Hub Industrial

Tratding Estate

Distt Lasbella.

ACERING Injection

(Ringer acetate injection)


Sodium acetate

Trihydrate….3.8gm

Potassium

chloride…..0.3gm

Calcium chloride

2H20….0.2gm

Sodium

chloride…..6.0gm

Water for injection

…..Q.s

Electrolyte solution

Manufacturer

Form-5

Dy. No : 43

dated 07-01-12

8000 dated 17-

01-12 replaced

by wfi 5ml

dated 11-02-

2011

Rs. 192.02/

Pack of 500ml

Acetated Ringer

Solution (USFDA)

Sterofundine

injection B.Braun

is closer mee too

of proposed

formulation

Deferred for


status and differential

fee.

Minutes for 253rd


ROUTINE (LOCAL-VET)

Evaluator III

503. -do- STERILE Water for

Injection

Each LDPE ampoule

contains:

Sterile water for

injection….20ml

Dilution of IV/IM

Injectables

USP

Form-5

Dy. No :

8000 dated 08-

02-11

12000 dated

12-08-13

Rs. 16/- LDPE

20ml ampoule

Approved

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price /

Pack size

International

status in

reference drug

agencies /

authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Decision

504. M/s Baariq

Pharmaceuticals,

Lahore

RESCUE-100 W/S

Powder


Amantadine

HCL….10gm

Antiviral

Manufacturer

ForM-5

Dy. No 188 dated

28-04-11

8000 dated 28-04-11

12000 dated 29-06-

13

Decontrolled/ Pack

of 100, 250, 500

gm, 1,2.5, 10, 25kg

Acedine Powder

of Leads Pharma

Approved

505. -do- ENROBAR-20 Oral

Liquid


Enrofloxacin….100gm

Antibiotic

Manufacturer

ForM-5

Dy. No 193 dated

28-04-11

8000 dated 28-04-11

12000 dated 29-06-

13

Decontrolled/ Pack

of 100, 250, 500 &

1000ml

FLOXIVET Oral

Liquid of Medivet

Lahore

Approved

Minutes for 253rd


506. -do- COXIRIQ Oral Powder


Sulfachlopyridazine…..

30gm

Antibiotic

Manufacturer

Form-5

Dy. No 188 dated

28-04-11

8000 dated 28-04-11

12000 dated 29-06-

13

Decontrolled/ Pack

of 100, 250, 500

gm, 1,2.5, 10, 25kg

SULZIN Powder

of Genome

Pharma (China)

Approved

507. -do- DOXI-TYLO C W/S

Oral Powder


Colistin

Sulphate…..500MIU

Tylosin

Tartrate…100gm

Doxycycline

HCL….200gm

Antibiotic

Manufacturer

Form-5

Dy. No 188 dated

28-04-11

8000 dated 28-04-11

12000 dated 29-06-

13

Decontrolled/ Pack

of 100, 250, 500

gm, 1,2.5, 10, 25kg

TRIPLEX Powder

of Mylab

Approved

508. -do- TRICHLOFON Powder

Each gm powder

contains:

Trichlorfon…..985mg

Anthelmintic

Manufacturer

Form-5

Dy. No 185 dated

28-04-11

8000 dated 28-04-11

12000 dated 29-06-

13

Decontrolled/ Pack

of 100, 250, 500

gm, 1,2.5, 10, 25kg

Triclofon Powder

of Breeze Pharma

Approved

509. -do- TIMOBAR Suspension


Sulphadiazine….40gm

Trimethoprim…..8gm

Antibiotic

Manufacturer

ForM-5

Dy. No 570 dated

21-09-11

8000 dated 28-04-11

12000 dated 29-07-

13

Decontrolled/ Pack

of 100, 250, 500 &

1000ml

Sulphabitic Oral

liquid of Grand

Pharma

Approved

Minutes for 253rd


510. -do- OXYBAR W/s Powder


Oxytetracycline

HCL…95gm

Antibiotic

Manufacturer

ForM-5

Dy. No 569 dated

21-09-11

8000 dated 21-09-11

12000 dated 29-07-

13

Decontrolled/ Pack

of 100, 250, 500

gm, 1,2.5, 10, 25kg

OXY-950 Powder

of Attabak Pharma

Approved

511. -do- TUTRAZURIQ Oral

Liquid


Triclabendazole….5gm

Levamisole….3.75

Antalmintic

Manufacturer

ForM-5

Dy. No 569 dated

21-09-11

8000 dated 21-09-11

12000 dated 29-07-

13

Decontrolled/ Pack

of 100, 250, 500 &

1000ml

Tridex Drench of

Guyton

Approved

Minutes for 253rd


A. Miscelleneous Cases.

Case No.01: Contract Manufacturing Policy.

Rule 20A of Drugs (L R & A) Rules, 1976 pertains to contract manufacturing of drugs.

These rules have been amended vide SRO 152(I)/2014 dated 04.03.2014. Sub-rule 2(b) is as

follows:

2(b) Contract manufacturing shall be allowed only on basis of similar category of drugs

including human to human, veterinary to veterinary, cotton to cotton, medical device to medical

device or as the case may be, etc.

M/s Chisti Pharma, Okara is a licensed pharmaceutical unit for cotton. The firm has

submitted in 250th

meeting of Registration Board that contract permission of our products Scifix

(Cefixime) capsule(057380) and dry powder for suspension 100 mg (057382) and 200 mg

(057381) has been denied. In this regard we want to present our submission as follows:

That our products were approved by registration board in 215th

meeting and subsequently

renewed in 238th

meeting of registration board. Our products are manufactured by a GMP

compliant facility McOlson Research Laboratories, Sheikhupura.

It is a settled principle of law that a subordinate authority cannot make rules or issue

notification under a statute so as to give them retrospective effect unless the statute itself

grants such powers. (PLD 1967 Kar. 184 (DB), PLD 1972 SC 686, PLD 1974 SC 291 at

page 309).

Drug Act, 1976 empowers the federal government to make rules under section 43 of

drugs Act, 1976 but it nowhere empowers to make rules with retrospective effect. Denial

of renewal of our product based upon new contract policy is retrospective in its effect.

Our products were granted by registration board in 215th

meeting in 2009 and

subsequently renewed in 238th

meeting in 2014. It is unjust to deny renewal on the

grounds that it doesn‟t fall under new contract policy. When our products were granted

approval, it was in accordance with the contract policy of registration board.

According to Drugs Act, 1976 there is no categorization of DML for bandages

manufacture. We were granted “Formulation” license by central licensing board and

under this license other drugs like tablets, capsules, injectables can be manufactured.

Therefore our DML has same legal value as it has for other dosage form manufacturers.

Drugs Act, 1976 has also provided a procedure for cancellation of registration of a drug.

No drug can be deregistered/cancelled unless opportunity of personal hearing is provided

to the applicant. In our case this principle of law has also been denied.

Based upon above grounds, it is requested to review decision of the board and grant us

extension of contract permission for our products. Sir, we have promoted our product through

ethical means and years of efforts are involved in this process. Decision of Registration Board

Minutes for 253rd


shall results in huge losses for our company and shall also deprive the patients from access to a

quality drug.

Decision: Registration Board deferred the case due to paucity of time.

Case No.02: Registration of Linagliptin & Linagliptin containing products.

Linagliptin and Linagliptin containing products were considered by Registration Board in

its 237th

, 242nd

and 245th

meeting of the Board for registration. M/s. AGP Pharma, Karachi has

been granted approval of drug, however, Linagliptin of M/s. CCL Pharma, Lahore and other

companies have been deferred by Registration Board for opinion of Law & Justice Division due

to the reason that M/s. AGP, Karachi had filed a writ petition in the Sindh High Court, Karachi

to bar other applicants to obtain registration of this drug. Registration Board in its 245th

meeting

has decided to refer the case for comments of Law Division.

The case was referred to Law, Justice & Human Rights Division for direction / view in the

following Decision of Sindh High Court, Karachi:-

“till the validity of plaintiff’s’ patent No. 141311, 141044 and 141068, defendants is

restrained from selling ‘Linagliptin’ containing products or manufacturing or making

formulating, supplying, stocking, importing, exporting, offering for sale, passing off,

advertising or otherwise enabling others to infringe or pass off, offer for sale or use in

any form in any manner which is in infringement of the claims of the petitioners patent.

Resultantly, pending application (s) is also disposed of.”

Law Division has furnished legal opinion as under:-

“In the case in hand the court categorically said that the drug has a patent registered in

Pakistan since 21.08.2002 and it has restrained the defendant from selling “linagliptin”. This

restriction is to the extent of defendants only and is prohibiting manufacturing or making

formulating, supplying, stocking, importing, exporting offering for sale, advertising or

otherwise enabling others to infringe or pass off, offer of sale or use in any form or in any

manger, which is in infringement of the claims of plaintiffs paten till the validity of patens.

Therefore, this makes it a right in personam. As regards consideration of the cases for

registration no such direction or injunction can be inferred from the offer placed in the

reference. Thus the injunction is regarding making, sale and selling etc., and no such

injection is directed towards the Registration Board”.

Decision: Registration Board deliberated the case and referred for views of IPO,

Pakistan.

Minutes for 253rd


Case No.03: Registration of generic Nilotinib

Advocate Mr. Kazim Hasan, Barrister-at-Law of M/s Novartis Pharma Limited has

informed that they have been instructed by Novartis to advise the Drug Registration Board of the

DRAP that the intellectual property rights to Nilotinib vests in Novartis globally. Nilotinib is a

breakthrough treatment of Lukemia and it has been developed by Novartis. M/s Novartis has

come to know that M/s Genix Pharma has applied for generic registration of Nilotinib under the

trade name Lukopenil. Being intellectual property rights to Nilotinib vests in Novartis globally a

generic Nilotinib would be a violation intellectual property rights.

Advocate Mr. Kazim Hasan has further submitted that such registration would also

constitute a sovereign breach, as Pakistan is a signatory to international treaties which guarantee

protection of intellectual property rights. He requested that application filed by Genix Pharma for

generic registration of a Novartis product may be rejected and Drug Registration Board should

not even entertain any application for generic registration Nilotinib under any trade name.

Registration Board in 246th

meeting forwarded above reference to IPO, Pakistan for

comments, which are as follows.

“Intellectual Property Organization (IPO) has stated that the main function of the Patient

Office is to receive and examine applications for patents and grant patents to qualifying

applicants. Concept of the patent is the grant of property right to the inventor over his invention,

by the state to exclude others from making, using, selling or offering for sale and importing the

invention into the country where his patent rights exists. An inventor or applicant seeking patent

has to apply with patent specification in the Patent Office. The Patent specification needs to

fulfill three patentability criteria: Novelty (newness), Inventive step (innovative) and Industrial

application. Once patent is granted, the patent owner has the power to sue those who infringe his

patent in a court of law to stop the infringement and receive monetary compensation (damages).

On the other hand, the manufacturer needs to obtain marketing approval from Drug

Regulatory Authority of Pakistan (DRAP) by submitting data as required under Drugs Act, 1976.

The data demonstrating the safety and efficacy of the drug for which marketing approval is being

sought has to be furnished. The marketing approval is then granted by the Drug Regulatory

Authority of Pakistan (DRAP) if the bioequivalence protocol (safety, efficacy, quality) is

satisfactory.

It is pertinent to note there are no administrative, legislative and regulatory provisions in

Pakistan permitting the system of Patent linkages with marketing approval of the drug. The

TRIPs provisions, to which the country is a party leaves is to national legislation to establish

patent linkage of the kind sought. The question of Patent – registration linkage is in reality a

TRIPS plus policy.

Decision: Registration Board deliberated in detail and decided to get detail of patent

granted for Nilotinib by IPO, Pakistan.

Minutes for 253rd


Case No.04. Import of veterinary drugs by M/s. Zoic International, Lahore.

Dr. Muhammad Aslam Niazi of Lahore vide a complaint alleged that M/s. Zoic

International, Lahore has got registration of number of veterinary/poultry medicines of M/s.

Tithebarn Limited UK illegally by submitting fake and forged documents. The complainant

further alleged that M/s. Tithebarn Limited UK is not a manufacturer of medicines.

As per record, following drugs of M/s. Tithebarn Limited UK were registered for import

by M/s. Zoic International, Lahore:-

S. No. Reg. No. Name of Drug (s).

1. 021297 Cocostop 20% Water Soluble Powder.

2. 021298 Quincure 20% Liquid.

3. 021299 Quintril 20% Liquid.

4. 021300 Quintril 10% Liquid.

5. 021301 Grow More Water Soluble Powder.

6. 023422 Premix PL300 Powder.

7. 049580 Tithedox Water Soluble Powder.

8. 049581 Tithemox Injection.

9. 049582 Tithemox Water Soluble Powder.

10. 049583 Enrobarn Water Soluble Liquid.

11. 057176 Tithemycin Water Soluble Powder.

12. 057177 Tithechlore 20% Water Soluble

Powder.

M/s. Zoic International, Lahore was given a show cause notice to clarify their position

with regard to the complaint. The firm, in response, denied the allegations stating that their

principle M/s. Tithebarn Limited UK abroad is a manufacturer. M/s. Zoic International, Lahore

was again directed to submit fresh original latest approval letter for the products (CoPP) / Defra

I&II issued by Regulatory Authority of United Kingdom, within 7days, failing which it will be

presumed that they have nothing to offer in their defence and an ex-party decision will be took

against them.

In response M/s. Zoic International, Lahore vide letter dated 15-06-2015 informed that in

order to submit fresh documents from concern / issuing department i.e VMD UK (Veterinary

Medicine Directorate) they may require 42 to 56 days. The firm has further given undertaking

that they will immediately stop any further import of these products until the matter is resolved.

In accordance with decision taken by the Board in its 252nd

meeting, representative of

M/s. Zoic International, Lahore was called for personal hearing. Mr. S.M Wasim Khan, Chief

Minutes for 253rd


Executive, M/s. Zoic International, Lahore and Mr. Salman Tauqeer, Advocate, appeared on

behalf of firm and claimed that the name and address of the complainant is fake, therefore, the

complaint is not valid .They were of the view that no action can be initiated on the complaint due

to aforementioned reasons. The representatives further informed that they have not imported any

of the above drugs since the issue has been raised and requested for another 45 days time for

submission of legalized and attested CoPP from abroad.

Decision:- The Board decided to allow 45 days time for submission of the properly

legalized CoPP for the products in question. In the meantime the firm will not import any

of the above products until the matter is resolved/ clarified.

Minutes for 253rd


Additional agenda:

A. Biological drugs:

Case No.01 Court case of Recombinant Bovine Growth Hormone (rBST OR

rBGH)

The decision of the honourable court dated 15/09/2015 is reproduced as follows:

1. Learned Deputy Attorney General has submitted a report with respect to the meeting

held by the Chairman Drug Registration Board (“Board”) on 31.8.2015. Learned Law Officer

states that in the meeting of the Board it was ultimately decided after hearing all the parties to

cancel the registration. He further states that detailed minutes of the meeting will be made

available in three weeks time. It is noted that an explanation has been tendered by the Chairman

of the Board with respect to non-compliance of the order of this Court, which is placed on the

file.

2. Learned law Officer submits that as per the decision of the Board, the Respondents will

commence enforcement proceedings. Learned counsel for the Respondents also stated that they

will pursue that remedy under the law.

3. Board was apprise the latest position of the title case and proceedings of the Lahore

High Court, Lahore it was explained that rBST containing product related to the large animal

(Bovine) has already been approved for cancellation of registration whereas the product namely

Fish Powder imported by Ghazi Brothers which also contains rBST and is approved as fish

growth promoter only is required to be re-examine by the Board in today‟s proceeding.

4. After detail discussion Board has decided the case as under:

Decision: The information regarding the latest status of the case under examination by

the Honorable Lahore High Court, was noted by the Registration Board. It

was further decided that the matter of fish powder be referred to following

Veterinary Experts for evaluation regarding formulation and its intended

use / abuse.

i. Dr. Muhammad Akram, Assistant Animal Husbandry Commission, Ministry of Food

Security, Islamabad.

ii. Dr. Qurban Ali, National Veterinary Laboratory, Islamabad.

iii. Dr. Muhammad Arshad, Member Registration Board, DRAP, Islamabad.

Minutes for 253rd


Case No. 02 APPEAL UNDER SECTION 3 OF THE LAW REFORMS

ORDINANCE, 1973, R/W SECTION 15 OF CPC (AMENDMENT),

ORDINANCE, 1980 R/W SECTION 96 CPC 1908

M/s Ghazi Brothers Karachi versus IZO SPA Italy

M/s Ghazi Brother Karachi is in business dispute with its principle IZO SPA Italy on

issue of cancellation of distribution agreement for their registered products in Pakistan.

Currently 40 IZO Poultry Vaccines have been granted registration for marketing into Pakistan

whereas 8 vaccines are in the process of evaluation. All the above 40 products are being

marketed by M/s Ghazi Brothers Karachi.

IZO SPA Italy on 20.03.2014 has terminated agency agreement in the name of M/s Ghazi

Brothers Karachi and notifies new incorporation office in the name of IZO SPA Pvt Ltd, Johar

Town, Lahore. This has also submitted fresh applications on 13.06.2015 which are pending for

the sake of evaluation and owing to the suit filed by M/s Ghazi Brothers Karachi (Ex distributor

in the High Court Sindh at Karachi.

Earlier through CMA No. 7175 the Plaintiff has prayed for:-

“....suspend the operation of termination letter dated 20.03.2014 and restrained

the defendants, its officers, employees, agents or any other person claiming through,

under or in trust for the defendants from applying and / or cancelling the registration

of the poultry vaccine products existing in the name of the plaintiff (mentioned in

Annex-B with momo of plaint), till.....”.

According to the agency agreements available on record between the parties dated 1st

June, 1996 and 31st October, 2002. The jurisdiction to settle the dispute is in Italy. Whereas it

was asserted that since the business is being executed in Pakistan hence the fruits of the

agreement and the cause of irreparable loss occurred due to the termination of agreement should

be given to the applicant.

Honourable Sindh High Court Sindh after detailed examination of the case in Suit No.

871/2014 dated 21.9.2015 maintained that:

‘11......Civil Procedure Cod does explain the ‘jurisdiction’, ‘try all suits unless barred’.

Rejection of the plaint or return thereof for presentation before proper form but nowhere

permits’ the Courts to stay the proceedings of the suit. Once a lis is brought to a file of the Court,

the law provides mechanism for disposal thereof which in no way could include an order of

staying proceedings for an indefinite period. However, at the same time, i am conscious that

procedure in Court at Brescia Italy may be different from the one, provided n the Civil

Procedure Code, therefore, returning of the plaint (Order VII r 10 CPC) for presentation before

proper forum would not meet the requirement of law rather may result in causing prejudice to

plaintiff while resorting to proper forum.

Minutes for 253rd


‘12...... In view of what has been discussed above, I am clear in my view that suit before this

Court is not maintainable and is dismissed accordingly. The dismissal however shall not

prejudice the rights of the plaintiff to institute proper proceedings for adjudication of its

grievances/claims, as per the applicable limitation of laws, if any.

M/s Ghazi Brothers Karachi has now field an inter court appeal considering that

Hon’ble single bench has not taken up the facts stated in the petition. Since the above matter is

under adjudication, hence being placed before the Registration Board meeting seeking directions

for and maintaining the status co to the matter till pendency of the appeal before Honourable

High Court Sindh at Karachi.

Decision: Registration Board noted the information.

Case No. 03 Cases of local manufacturing of veterinary biological drugs.

The following cases of locally manufactured biological drugs are placed before the

Registration Board.

Sr.No Name of the

Manufacturer

Name of Drug and

Composition

Demanded Priced Date of Application

1.

Bio-Labs ,

Islamabad

Plot No 145,

Industrial triagle

Kahota Road ,

Islamabad

BIO-NDFLU

ND VIRUSES

(MUKTESWAR) 10

AND H9N2 VIRUS

DE-CONTROLLED 29.05.2013

2.

Grand Pharma

(pvt), Islamabad

GPVAC ND+IB+IBD

COMBINED

NEWCASTLE

DISEASE,

INFECTIOUS

BRONCHITIS &

INFECTIOUS

BURSAL DISEASE

VACCINE


3.

Grand Pharma

(pvt), Islamabad

GPVAC CORYZA INJ

30ML, 300ML, 600ML

KILLED

INFECTIOUS

CORYZA VACCINE


4.

Grand Pharma

(pvt), Islamabad

GPVAC IB PLUS

BIVALENT IBV

VARIANT VACCINE


5.

Grand Pharma

(pvt), Islamabad

GPVAC ORT

KILLED ORT

VACCINE


Minutes for 253rd


6.

Grand Pharma

(pvt), Islamabad

GPVAC CONJUFLU -

ND LIVE

AIVH9+NDV

VACCINE


7.

Grand Pharma

(pvt), Islamabad

GPVAC SALMONEL

KILLED FOWL

TYPHOID VACCINE


The above cases needs to be evaluated for the purpose of evaluation of manufacturing

techniques, vaccines safety, efficacy and quality parameters. It is proposed that the products may

be referred to experts for comprehensive evaluation and product specific inspection.

Matter is placed before the Board for a decision.

Decision: Registration Board deliberated and deferred the case for technical opinion

Dr.Muhammad Arshad (Member, Registration Board- veterinary expert) as he was not

present in the meeting.

Case No. 04 Cases of Imported Products of Veterinary Biological Drugs

S.#. Name of

Indenter/

Manufactu

rer

Manufacturer Name of Drug (s)/

Composition &

Therapeutic

Group

Date of

application

/ Fee status

Documentary

Details

Remarks

1. Ghazi

Brothers

Karachi.

IZO S.P.A

Via A. Binachi

Italy

IZOVAC ND-FLU

EMULSIFIED

INACTIVATED

VACCINE

AGAINST

NEWCASTLE

DISEASE AND

AVIAN

INFLUENZA A

15-Jul-08

Deposited

fee

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

COURT

CASE +

NEW

MOLECU

LE+

Referred

from

Appellate

Board

2. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Laboratorios

Hipra S.A.

Avda. La

Selva Amer

(Girona)

Spain.

Avisan Multi

Each dose

contains:

- Avian Infectious

Bronchitis virus,

inactivated, strain

H52 HAI1 : 2

6 - 2

8

- Newcastle Disease

Virus

inactivated, La

Sota strain

…………………..

03.08.2010

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

N 1765ESP

DML No.

Free Sale

Certificate.

YES

Me too

i.GALLIM

UNE 302

Reg

No.049592

ii.LIVONO

BILIS

(IB+ND+E

DS)

Minutes for 253rd


HAI2 : 2

4 – 2

6

- Egg Drop

Syndrome virus

inactivated,

Adenovirus-127

strain ………...

HAI1 : 2

7 – 2

9

1 Mean titre of the

haemagglutionation

inhibition after

inoculation of a

dose of vaccine to

SPF chicks 2 Mean titre of the

haemagglutionation

inhibition after

inoculation of a

dose of 1/50

vaccine to SPF

chicks

(Biologicals)

(Veterinary use

only)

Indications. New Castle

Disease (ND),

Infectious

Bronchitis (IB),

Egg Drop

Syndrome

(EDS)

iii. ND

EDS IB

by IZO

iv. AV

PRO 303

by

LOHMIN

v. CEVAC

ND IB

EDS Reg

No.022799

3. Ghazi

Brothers

Karachi.

Brilliant Bio

Pharma limited

Hyderabad,Ind

ia

19-Feb-10

Deposited

fee

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

New

Molecule

The case

may be

deferred as

the dossiers

is not

traceable

and the firm

has shown

its non

concern

from the

exporter.

Minutes for 253rd


4. Mustafa

Brothers

Faisalabad.

Veyx-Pharma

B.V.,

Forellenwegm

SJ

Raamsodonksv

eer, The

Netherlands,

Vexy Pharma

Germany

Hypophysin® LA

injectable Solution

Each 1ml

contains:-

Carbetocin……0.7

mg

Chlorobutanolum

hemihydrate…2.00

mg Sodium Acetate

trihydrate….0.5mg

Acetic Acid,

glacial…..3.0mg

WFI….1,4004.43m

g (Minux 'X', see

below) Sod.

Hydroxide....0.8mg

(X=20% solution to

adjust the pH-

value)

For Vetrinary use

only.

26-Mar-10

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too

5. ICI

Pakistan

Limited,

Karachi.

Intervet

International

GmbH,

Unterschleissh

eim, Germany.

Receptal Injectable

Solution Each ml of

solution for

injection contains:-

Buserelin acetate

4.2 micrograms

(corresponding to

0.4 micrograms

buserelin)

(Gonadotropin-

releasing hormone).

(For Veterinary

Use).

11-Apr-10

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

New

Molecule

6. Vet Line

Internationa

l, Lahore.

CEVA-

PHYLAXIA

Veterinary

Biologicals

Co. Ltd.,

Budapest,

Hungary.

Licence

Holder:-

Laprovet

Hungary

Veterinary

Pharmaceutica

l LTd.

Budapest,

Hungary.

AVI ND Lasota +

IB Vaccine

Each one dose

contains:-

Newcastle disease

virus (NDV),

LaSota strain…min.

105.5

EID50

Infectious

bronchitis virus

(IBV), B-48

strain…min.

102.6

EID50

(Biological-Avian

Live Vaccine).

(For Veterinary

Use).

24-Jun-10

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too

Minutes for 253rd


7. Vet Line

Internationa

l, Lahore.

CEVA-

PHYLAXIA

Veterinary

Biologicals

Co. Ltd.,

Budapest,

Hungary.

Licence

Holder:-

Laprovet

Hungary

Veterinary

Pharmaceutica

l LTd.

Budapest,

Hungary

AVI POX Vaccine

Each one dose

contains:- Fowl Pox

virus, Cutter strain

min…….102.7

EID50 (Biological-

Avian Live

Vaccine).

(For Veterinary

Use).

24-Jun-10

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too

8. Vet Line

Internationa

l, Lahore.

CEVA-

PHYLAXIA

Veterinary

Biologicals

Co. Ltd.,

Budapest,

Hungary.

Licence

Holder:-

Laprovet

Hungary

Veterinary

Pharmaceutica

l LTd.

Budapest,

Hungary.

ITA NEW (ND)

Vaccine Each dose

(0.5ml) contains:-

Inactivated

Newcastle disease

virus min(NDV-

SZ)…50 PD50 “SZ”

LaSota Strain

(Biological-Avian

inactivated

Vaccine).

(For Veterinary

Use).

24-Jun-10

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too

9. Hospital

Services &

Sales,

Karachi.

BIOLOGICAL

CO. LTD.,

Beijing,

P.R. China.

QYH-ND EDS

VAC

Each one dose

contains:- White

mineral oil for

injection, span,

Tween-80,

aluminium stearate,

and Allantoic fluids

from both NDV

infected chicken

embryonic eggs and

EDSV infected

duck embryo. The

titer of ND Virus in

> 108.0

EID50/0.1ml before

inactivation, those

of Egg drop

syrdrome virus is

25-Jun-10

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

Production

Licese No.

1008 (2009)

GMP

Certificate No.

029 (2008)

DML No.

Free Sale

Certificate No.

10082043

Indications.

Me too

status not

confirmed

The

documents

are not

verified by

the

Embassy of

Pakistan

Minutes for 253rd


> 107.0

EID50/0.1ml before

inactivation.

(For Veterinary

Use) 10. Vet Line

Internationa

l, Lahore.

CEVA-

PHYLAXIA

Veterinary

Biologicals

Co. Ltd.,

Budapest,

Hungary.

Licence

Holder:-

Laprovet

Hungary

Veterinary

Pharmaceutica

l LTd.

Budapest,

Hungary

AVI IBD PLUS

Vaccine Each dose

contains:-

Infectious Bursal

Disease virus

Winterfiled 2512,

G61 strain…….at

least 2.0log10

EID50

(Biological-Avian

Live Vaccine).

(For Veterinary

Use).

29-Jun-10

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too

11. Mustafa

Brothers

Faisalabad.

Vexy Pharma

GmbH,

Germany

PGF Veyx ® Solution

for Injection Each

1ml contains:-

Cloprostenol

Sodium…..0.092mg(e

quivalent to

0.0875mg

Cloprostenol)(Prostag

landin F2a-agonists)

15-Sep-10

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too

12. Hospital

Services &

Sales,

Karachi.

QYH (QIAN

YUAN HAO)

BIOLOGICAL

CO. LTD.,

Beijing,

P.R. China.

QYH-ND Live

Vaccine Each one

dose contains:-

Newcastle Disease

Virus Sota

Strain).HA titer of

allanttoic fluids

> 106.5

EID50/0.1ml before

freeze drying.

(Veterinary

Vaccine).

(For Veterinary

Use).

22-Dec-10

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

(2010) 01008

Free Sale

Certificate No.

010082074

Indications

The

documents

are not

verified by

the

Embassy of

Pakistan

13. Golden

Harvest,

Karachi.

Lohmann

Animal

HealthInternati

onal, Winslow,

Maine, United

AviPro ® 108 FC 3

PlatinumVaccine

Each per dose

(0.25ml) contains:-

Pasteurella

22-Mar-11

Deposited

fee

CoPP No.

DML No.

Free Sale

May be

deferred as

no

response

from the

Minutes for 253rd


State of

America.

multocida, X-73

strain (Type

1)……….108.5

CFU Pasteurella

multocida, P-1662

strain (Type

4)….108.5 CFU

Pasteurella

multocida, 86-1913

strain (Type

3x4)…108.5 CFU

(Inactivated poultry

vaccine).

15000

Balance Fee

85000

Certificate

Indications

experts.

Deferred

for strain

for

Pakistani

Market By

following

experts

Prof Dr

Khushi

Muhamma

d

Prof Dr

Masood

Rabani

Dr Arshad

Dr

Manzoor

(M-240)

Deffered

for

clarificatio

n of

information

sought ny

committee

and review

by already

constituted

committee

and

veterinary

expert of

ECBD (M-

241) 14. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Boreingher

Ingelheim,

USA

Calvenza-03

EIV/EHV

Each dose contains:

Equine Herpesvirus

Type 1, strain KyA

(active ingredient)...

RP ≥ 1.0*

Equine Influenza,

strain

Newmarket/2/93,

subtype A2 (active

ingredient) ... ≥

128 HUH**

Equine Influenza,

strain Kentucky/95,

26-Mar-11

Deposited

fee

50000

Balance Fee

Nil

CoPP No. No

need

DML No. 124

Free Sale

Certificate No.

1500865

Indications:

Equine

Influenza in

Horses (EI)

Deffered

for strain

for

pakistani

Market By

following

experts

Prof Dr

Khushi

Muhamma

d

Prof Dr

Masood

Rabani

Dr Arshad

Minutes for 253rd


subtype A2 (active

ingredient)... ≥ 128

HUH**

Equine Influenza,

strain A/Equi-

2/Ohio/03 (active

ingredient)... ≥ 128

HUH**

Carbopol (adjuvant

0.5%)…… 20 ± 5%

Ethylenediaminetetr

aacetic acid

(chelating agent

14%)…..

0.134%***

Thimerosal

(preservative 2.…

0.1 – 0.2%

Gentamicin

(preservative,

residual amount

from medium)…. ≤

30µg/mL

Sodium chloride

solution (adjust

antigen

concentration

0.85%) …qs to

2mL .......

*RP= Relative

Potency when

compared to a

standard reference

vaccine by in vitro

test

**HAU=

Hemagglutination

units

***Quantity of

chelating agent is

by calculation

(Biologicals)

Dr

Manzoor

(M-240)

Minutes for 253rd


15. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Boreingher

Ingelheim,

USA

Elite 9 HS

Each dose contains:

Active Ingredients

Bovine

Rhinotracheitis

Virus (IBR)…

….min 1.58 x 10 8

or 10 8.2 virus

particles

Bovine Virus

Diarrhea Virus

(BVD) ……min

1.27 x 10 7 or 10

7.1 virus particles

Myxovirus

parainfluenza3

(PI3)…… min 1.00

x 10 8 or 10 8.0

virus particles

Bovine respiratory

syncytial virus

(BRSV)... .min 1.58

x 10 6 or 106.2

virus particles

Haemophilus

somnus P51… .min

3.1 x 10 8

organisms

Haempphilus

somnus,

Oklahoma…… min

3.1 x 10 8

organisms

Leptospira

canicola…… min

1.0 x 109 organisms

Leptospira

grippotyphosa…mi

n 7.0 x 10 8

organisms

Leptospira

hardjo……min 7.0

x 10 8 organisms

Leptospira

icterohaemorrhagia

e..min 1.0 x 10 9

organisms

Leptospira

pomona… min 7.0

x 10 8 organisms

Non-active

Ingredients

26-Mar-11

Deposited

fee

50000

Balance Fee

Nil

CoPP No. No

need

DML No. 124

Free Sale

Certificate No.

1402128

Indications:

For Cattles

Bovine Rhino

Tracheitis

(IBR), Bovine

Diarrhea Virus

(BVD),

Parainfluenza 3

(PL3), Bovine

Respiratory

Syncytial Virus

(BRSV).

New

Molecule

Minutes for 253rd


Potassium

aluminium (10%)…

.max. 125 µl

Thiomersal

(merthiolate)…ax.

84 µl

Neomycin … .max.

42 µl

Physiological

saline… .Qsf - as

necessary

(Biologicals)

16. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Laboratorios

Hipra S.A.

Avda. La

Selva Amer

(Girona)

Spain.

Avisan Secure

Each dose contains:

- Inactivated

Salmonella

Enteritidis

PT4……….….

MAT ≥ 1/13*

- Inactivated

Salmonella

Typhimurium

DT104..…. MAT ≥

1/40* ………..

* Title obtained by

Microagglutination

technique on plates

after

inoculation of the

vaccine in SPF

chicks.

(Biologicals)

31-Mar-11

Deposited

fee

100000

Balance Fee

Nil

DML No.

N 1720 ESP

dated 25-1-

2007

Indications:

For Poultry

Salmonella

Enteritidis (SE),

Salmonella

Typhimurium

(ST).

Mee too

confirmed

i.

LAYERM

UNE SE

Reg

No.020126

by

BIOMUNE

.

17. Vet.

Pharma

Trading

Company,

New Steel

Market,

Near

Regent

Cinema,

G.T. Road,

Gujranwala

- Pakistan./

KBNP, Inc.

Dugok-ri,

Sinam, Yesan,

Chungnam.

Korea.

Himmvac Fowl Pox

Vaccine Each dose

contains:-

Fowl Pox virus

2775 strain…30%

(at least 102.0

EID50)

(Biological Product

Vaccine).

(For Veterinary

Use).

16-Apr-11

Deposited

fee

15000

Balance Fee

85000

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too

Minutes for 253rd


18. Mustafa

Brothers

Faisalabad.

Federal State

Unitary

Enterprise

“Stavropol

Biofactory”

Russia.

Formol Vaccine

Against

Pasteurellosis of

Cattle And Buffalos

Semi-Liquid,

Aluminium

Hydroxise

Composition in

complete

-active constituent

of Pasteurella

multocida (serotype

B), The

concentration of

microbiological

cells in the vaccine

must be not less

than 6

Milliard/cm3;

-phosphate- buffer

suspension is

aluminum

hydroxide as

sorbent 7.5%;

-inzc tivant

formalin-practically

is not revealed.

(Immunity

Biological

preparation

vaccines).

28-May-11

Deposited

fee

15000

Balance Fee

85000

CoPP No.

DML No.

Free Sale

Certificate

Indications

Check for

fee and

Mee too

status

19. Mustafa

Brothers

Faisalabad.

Federal State

Unitary

Enterprise

“Stavropol

Biofactory”

Russia.

Vaccine Against

Birds Influenza

Inactivated

Emulsified Flu

Protekt H5

Composition in

complete

(Immunity

Biological

preparations.

Homogeneous

water emulsion of

ethe white or white-

pink color).

28-May-11

Deposited

fee

15000

Balance Fee

85000

CoPP No.

08/2010/BG

Dated 15-2-

2010.

GMP No.

DE/15/001/200

8

Dated 13-2-

2008

Check for

fee and

Mee too

status

20. Vety-Care

(Pvt) Ltd.,

Rawalpindi.

Cahic Lanzhou

Bio-

Pharmaceutica

l, China.

FMD Bivalent

Vaccine (FMDV

Virus type O &

Asia I) Each 0.2ml

contains:-

Not less than 107.0

LD50 in 0.2ml

23-Jul-11

Deposited

fee

15000+

50000

CoPP No.

DML No.

Free Sale

Certificate

Me too

Minutes for 253rd


solution

(Vaccine)

(For Veterinary

Use).

Balance Fee

35000

Indications

21. Hilton

Pharma

(Pvt) Ltd.,

Karachi.

PT. MEDION

JI. Raya

Batujajar

Cimareme,

Kabupaten

Bangdung,

Indonesia.

Medivac Pox

Vaccine

Each dose of

vaccine contains:-

Live attenuated

fowl pox virus of

M-92 strain at least

103 EID50

(Freeze dried live

vaccine against

infectious

Laryngotracheitis

(ILT) in poultry

(broilers, roosters,

layers and

breeders).

(For Veterinary

Use).

8-Feb-11

Deposited

fee

15000+

35000+

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too

status

confirmed

i.HIPRA

POX

By Marush

from

HIPRA

Germany.

22. Hilton

Pharma

(Pvt) Ltd.,

Karachi.

PT. MEDION

JI. Raya

Batujajar

Cimareme,

Kabupaten

Bangdung,

Indonesia.

Medivac ILT

Vaccine

Each dose of

vaccine contains:-

Live attenuated

Infectious

Laryngotracheitis

virus of A 96 strain

at least 102.5

EID50 (Freeze

dried live vaccine

against infectious

Laryngotracheitis

(ILT) in poultry


layers and

breeders).

(For Veterinary

Use).

8-Feb-11

Deposited

fee

15000+

35000+

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too

status

confirmed

i. LT 1

VAX

By ICI

Pakistan

23. Vety-Care

(Pvt) Ltd.,

Rawalpindi.

Intervet

International

B.V. Wim de

Korverstraat,

AN Boxmeer,

Netherland.

Nobilis SG 9R

Vacccine Each dose

0.2ml contains:-

Salmonella

Gallinarum strain

9R in

stabilizer………at

least 2x107 CFU

(Live vaccine).

18-Oct-11

Deposited

fee

15000+

85000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

ECBD

Recommen

ded (M-

240)

Deferred

for

clarificatio

n about

justificatio

n of live

Minutes for 253rd


virus strain

(241)

24. Vety-Care

(Pvt) Ltd.,

Rawalpindi.

Intervet

International,

USA.

Innovax-Nd

Vaccine Each dose

contains:-

Live Turkey Herpes

Virus strain

HVT/NDV-

F>……at least

1810 PFU per bird

dose.

(Live virus

vaccine)

18-Oct-11

Deposited

fee

15000+

85000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

ECBD

Reccomme

nded (M-

240)

Deferred

for

clarificatio

n about

serotype of

strain

NDV-F

and and

review by

already

constituted

committee

and

veterinary

expert of

ECBD. (M-

241) 25. Snam

Pharma,

Lahore. /

Bioveta a.s.

Ivanovice na

Hane, Czech

Republic.

Ornibur

Intermediate Plus,

Lyophilizate for the

preparation of

suspension for

domestic fowl Each

one dose contains:-

Virus bursitidis

avium, strain IBDV

OP-1, min. 104.0

TCID50-

max.105.2 TCID50

(Vaccine).

31-Oct-11

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Deffered

for strain

for

pakistani

Market By

following

experts

Prof Dr

Khushi

Muhamma

d

Prof Dr

Masood

Rabani

Dr Arshad

Dr

Manzoor

(M-240)

Defered for

testing of

extraneous

pathogens

Minutes for 253rd


by NVL at

the cost of

applicant.

(M-241)

The report

of NVL is

attached

on the last

page of

Agenda. As

per report

“The

sample

submitted

and

referred

above

complies

the test

requireme

nts”

26. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Laboratorios

Hipra S.A.

Avda. La

Selva Amer

(Girona)

Spain.

HipraBovis-4

Each dose contains:

- Inactivated

Infectious Bovine

Rhinotracheitis

Virus (IBR),

strain LA

…………………..

≥ 107 TCID50

- Inactivated

Parainflenza-3

Virus (PI-3), starin

SF4... ≥ 480 HAU

- Inactivated

Bovine Diarrhoea

Virus (BVD),

Strain NADL

……..….. ≥ 106

TCID50

Freeze-dried

fraction:

- Live Bovine

Respiratory

Syncitial Virus,

Strain LYM P56

……..….. ≥ 104

TCID50

(Biologicals)

26-Nov-11

Deposited

fee

15000

Balance Fee

35000

CoPP No.

N 2772 ESP

DATED 09-4-

2013

Indications:

For Cattle

Bovine

Rhinotracheitis

Virus (IBR),

Bovine

Respiratory

Syncitial Virus

(BRSV),

Parainfluenza

3(PI3)

New

Molecule

Minutes for 253rd


27. Ghazi

Brothers

Karachi.

Kofavet

Special Inc

Korea

BIOTECTOR S1 W

BACTERIOPHAG

E….1.0X10PFU

15-Dec-11

Deposited

fee

15000+

35000

Balance Fee

50000

CoPP No.

DML No.

Free Sale

Certificate

Indications

Check for

fee and Me

too status

28. Ghazi

Brothers

Karachi.

BIOTECTOR S1

BACTERIOPHAG

E

15-Dec-11

Deposited

fee

15000

Balance Fee

35000

CoPP No.

DML No.

Free Sale

Certificate

Indications

New

Molecule

29. Saadat

Internationa

l, Lahore.

Laboratoire

Porte Des

Alpes, Saint

Priest, France.

Nemovac Vaccine

Each dose of

vaccine contains:-

Attenuated Swollen

Head Syndrome

virus, PL21 strain,

at least 102.3

CCID50

(Biological

Products).

18-Apr-12

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Check for

Me too

i.Izovac

SHS Live

by IZO

II.Hipra

VIAR SHS

by Marush

30. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Ceva

Phylaxia

Biological Co.

Ltd., Budapest,

Hungary.

Cevac Corymune 4

K Injectable

Contains:-

-Avibacterium

paragallinarum

Serotype A….Min.

7 Log10 CFU

before inactivation.

-Avibacterium

paragallinarum

Serotype B….Min.

7 Log10 CFU


-Avibacterium

paragallinarum

Serotype C….Min.

7 Log10 CFU


-Salmonella

Enteritidis

(SE)……induce

min 5 log2 MAT

(Biological)

23-Apr-12

Deposited

fee

100000

Balance Fee

Nil

Certificate of

Origin and Free

Sale No.

MA-

HU/06V/2006

/M21

Indications:

For Poultry

Avian Coryza

(AB&C),

Salmonella

Enteritidis.

Confirmed

Mee too

i.HEMOV

AX Reg

No.011485

by Marial

ii.

IZOVAC

Coryza by

IZO

iii.

MULTIM

UNE ABC

Reg

No.035030

by

BIOMUNE

Minutes for 253rd


31. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Phylaxia

Biological Co.

Ltd., Budapest,

Hungary

Cevac Corymune 7

K Injectable

Contains:-

-Newcastle Disease

(ND) virus, strain

“SZ”

Lasota…..induced

min.6 log2 HI with

1 dose or min.4

log2 HI with 1/50

dose or min..50

PD50

-Infectious

Bronchitis (IB)

virus, “M-

41”…..induce

min….6 log2 HI

-Egg Drop

Syndrome, 76

(EDS) virus, strain

“B8/78”….induce

min.7 log2 HI

-Avibacterium

paragallinarum

Serotype A….Min.

7 Log10 CFU


-Avibacterium

paragallinarum

Serotype B….Min.

7 Log10 CFU


-Avibacterium

paragallinarum

Serotype C….Min.

7 Log10 CFU


-Salmonella

Enteritidis

(SE)……induce

min 5 log2 MAT

(Biological)

23-Apr-12

Deposited

fee

100000

Balance Fee

Nil

Certificate of

Origin and Free

Sale No.

MA-

HU/06V/2006

/M21

Indications.

For Poultry

Newcastle

Disease (ND),

Infectious

Bronchitis (IB),

Egg Drop

Syndrome

(EDS), Avian

Coryza

(AB&C).

Solmonella

Enteritidis (SE)

me too

status

Confirmed

i. IZOVAC

ND EDS

hg3 by IZO

ii.

LAYERM

UNE 3

Reg. No.

020125 by

BIOMUNE

Minutes for 253rd


32. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

CEVA-

PHYLAXIA

vetneriary

Biologicals

Co.Ltd

Hungary

Cevac IBird

Each dose contains:

1.1 Active

substance

Avian infectious

bronchitis virus,

variant strain 1/96

at least 2.8 log 10

EID50 Ph. Eur.

0442

1.2 Virus protecting

components of the

excipients

Gelatine max. 10µg

Ph. Eur. 0330

Hydroxypropylbeta

dex max. 100µg Ph.

Eur. 1804

Sucrose max.

200µg Ph. Eur.

0204

(Biologicals)

17-May-12

Deposited

fee

50000

Balance Fee

Nil

Certificate of

Origin and Free

Sale No.

MA-

HU/06V/2006

/M21

Free Sale

Certificate No.

3378/1-4/13

Indications.

For Poultry Use

Infectious

Bronchitis (IB)

Variants

New

Molecule

33. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Laboratorios

Hipra S.A.

Avda. La

Selva Amer

(Girona)

Spain.

Toxipra S7

Each dose contains:

β toxoid of

Clostridium

perfringens type B,

C and D …> 10 UI

antitoxine β/ml of

serum

ε toxoid of

Clostridium

perfringens type B,

C and D ….> 5

UIantitoxine ε/ml

of serum

α toxoid of

Clostridium novyi

type B

…………………..>

3.5 UI antitoxine

α/ml of serum

α toxoid of

Clostridium

septicum

….………………

…..> 2.5 UI

antitoxine α/ml of

serum

Anaculture of

Clostridium

6-Aug-12

Deposited

fee

15000+

35000

Balance Fee

Nil

CoPP No.

N 2770 ESP

Prod License

No. 2770ESP

Dated 09-4-

2013

GMP No.

ES/030/14

Dated 04-3-

2014

F

ree Sale

Certificate No.

Dated 04-12-

2014

Indications.

For Cattle,

Sheep & Goat.

Clostridium

infections

caused by CL

Perfringens

(BCD), CL

Septicum, CL

New

Molecule

Minutes for 253rd


chauvoei

......................100%

protection in guinea

pig

Anaculture of

Clostridium

sordellii

........................100

% protection in

guinea pig

(Biologicals)

Chauvoei, CL

Sordellii

34. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Laboratorios

Hipra S.A.

Avda. La

Selva Amer

(Girona)

Spain.

Hipraviar –

Clon/H120

Injectable Each per

dose (0.03ml)

ocular- nasal route)

contains:-

Live Newcastle

Disease Virus,

CL/79

clon…….> 106.5

EID50 Live

Infectious

Bronchitis Virus,

strain H-

120…….>103

EID50

(Biologicals).

27-Jun-12

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

N 2275 ESP

Dated 04-12-

2014

Indications.

For Poultry Use

Newcastle

Disease (ND

Clone),

Infectious

Bronchitis (IB).

Confirmed

Mee too

status

i. NOBILIS

ma5

+Clone 30

by MSE

ii.

IZOVAC

CHB by

IZO

35. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

Laboratorios

Hipra S.A.

Avda. La

Selva Amer

(Girona) Spain

Hipraviar ILT

Each dose contains:

Live Avian

Infectious

Laryngotracheitis

Virus, strain CHP

50 … > 103 – 103.5

EID50

(Biologicals)

Hipraviar ILT

Each dose contains:

Live Avian

Infectious

Laryngotracheitis

Virus, strain CHP

50 … > 103 – 103.5

EID50

(Biologicals)

28-Jun-12

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

N 2237 ESP

DATED 16-2-

2011

DML No.

Free Sale

Certificate

Dated 04-12-

2014

Indications. For

Poultry Use.

Avian

Infectious

Laryngotracheit

is Virus (ILT)

Me too

Confirmed

i. NOBILIS

ILT by

MSD

ii.

IZOVAC

ILT by IZO

iii. CEVAC

LTL Reg

No. 022791

by Selva

iv.VECTO

RMUNE

FP LT Reg

No. 039931

by

BIOMUNE

Minutes for 253rd


36. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

CEVA-

Biomune

Veterinary

Biologicals

Company,

Lenexa, KS

USA.

Vectormune HVT

AIV Injectable

Each dose

contains:-

HVT/AIV virus in

CP#1…50- 90%

Cryoprotectant

#2……10-50%

(Biologicals).

29-Jun-12

Deposited

fee

50000

Balance Fee

Nil

Free Sale

Certificate No.

1500379

DML No. 368

Indications. For

Poultry Use.

It is transported

in special

containers fill

with Liquid

Nitrogen Gas

Avian Influenza

– H5 (Bird

Flue)

Reply

Deffered

for

clarificatio

n regarding

technical

details

about

transportati

on and the

compositio

n and

review by

already

constituted

committee

and

veterinary

expert of

ECBD.(M-

241) 37. Vet.

Pharma

Trading

Company,

New Steel

Market,

Near

Regent

Cinema,

G.T. Road,

Gujranwala

- Pakistan./

KBNP, Inc.

Dugok-ri,

Sinam, Yesan,

Chungnam,

Korea.

Himmvac Dalguban

SG9R Live Vaccine

Each dose

contains:-

Salmonella

gallinarum 9R

strain……..at least

2x107 CFU/dose

(Poultry Vaccine).

19-Jul-12

Deposited

fee

15000

Balance Fee

85000

CoPP No.

DML No.

Free Sale

Certificate

Indications

Check for

fee and

Mee too

status

Minutes for 253rd


38. Hilton

Pharma

(Pvt) Ltd.,

Karachi.

PT. MEDION

JI. Raya

Batujajar

Cimareme,

Kabupaten

Bangdung,

Indonesia.

Medivac ND-

Gumboro Emulsion

Vaccine

Each dose (0.5ml)

of vaccine

contains:-

Inactivated

Newcastle disease

virus of LaSota

strain at least 50

PD50

Inactivated

infectious bursal

disease virus of

Winterfield 2512

strain at least 800

serum

neutralization (SN).

(Freeze dried live

vaccine against

infectious

Laryngotracheitis

(ILT) in poultry


layers and

breeders).

(For Veterinary

Use).

2-Sep-12

Deposited

fee

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Confirmed

Mee too

status

i. IZO

VAC ND

IBD by

Ghazi

Brothers

from IZO

England

ii. HYPRA

GUMBOR

OBPL 2.

By Marush

from

HYPRA

Germany.

39. Vet.

Pharma

Trading

Company,

New Steel

Market,

Near

Regent

Cinema,

G.T. Road,

Gujranwala

- Pakistan./

KBNP, INC,

Dugok-ri,

Sinam, Yesan,

Chungnam,

Korea

Himmvac ND Oil

Vaccine Each vial

contains:-

Inactivated ND

virus (B1)…..30%

(At least 108.8

EID50/dose)

(Biological

Products).

(For Veterinary

Use).

10-Sep-12

Deposited

fee

15000+

35000+

65000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Check for

earlier

proceeding

s, may be

approved

product of

240 or 241

Minutes for 253rd


40. Ghazi

Brothers

Karachi.

IZO S.p.A.,

Via A. Bianchi

9, Brescia,

Italy.

Izovac CHB

Multidose Freeze-

Dried Bottle

Each dose of

vaccine contains:-

Live attenuated

Newcastle Disease

Virus Strain

Clone…..106

EID50

Live Attenuated

Infectious

Bronchitis Strain

Massachusetts

H120……103EID5

0

Live Attenuated

Infectious

Bronchitis Strain

28/86…..103EID50

(Immunological)

7-Oct-12

Deposited

fee

15000

Balance Fee

35000

CoPP No.

DML No.

Free Sale

Certificate

Indications

Check for

fee and

Mee too

status +

Court case

with IZO

Italy and

IZO

Pakistan

Lahore

41. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

CEVA-

Biomune

Veterinary

Biologicals

Company,

Lenexa, KS

USA.

Circomune W Oral

Each dose of

vaccine contains:-

Chickem Anemia

Virus…at >

……106.2

TCID50/dose

(Biologicals).

10-Jul-12

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Application

is

withdrawn

by the

company

May be

withdrawn

42. Marush

(Pvt)

Limited, K-

123, Model

Town,

Lahore.

CEVA-

Biomune

Veterinary

Biologicals

Company,

Lenexa, KS

USA.

Circomune

Injectable

Each dose of

vaccine contains:-

Chicken Anemia

Virus……at

>…..104.9

TCID50/dose

Glycerol…………

……………2 0%

20% BVlue Dye

Solution…….1%

(Biologicals).

10-Jul-12

Deposited

fee

15000 +

60000

(Nov. 2010)

Balance Fee

20000

Manufacturing

License No.

368

Dated 23-12-

1988

Free Sale

Certificate No.

1402568

Indications. For

Poultry Use

Disease.

Chicken

Anemia Virus

(CAV)

USDA

Approved.

Mee too

status

Confirmed

i. NIBULIS

CE by

MST

ii.

AVIPRO

THYMOV

AC by

LOWMAN

Minutes for 253rd


43. ICI

Pakistan

Limited,

Karachi.

Intervet

GesmbH,

Siemensstrabe

107, A 1210

Wien Austria

Revalor XS Implant

Each implant (10

pellets contains:-

Trenbolone

acetate……..200mg

17 β-

Estradiol….40mg.

For Veterinary

Use).

12-Oct-12

Deposited

fee

100000

Balance Fee

Nil

CoPP No.

LCN 480.912-

0020 (Austria)

Dated 26-11-

2010

Prod Reg No.

141-269 (USA)

Dated 19-1-

2007

New

Molecule

44. ICI

Pakistan

Limited,

Karachi.

Intervet Inc.

Corner of

Delaware

Avenue and

Monroe Street

Millsboro,

Delaware

19966 USA.

Fortegra Vaccine

(Coccidiosis

Vaccine Live

Oocysts)

The amount of

antigenic material

per dose in the final

container :-

Minimum of

sporulated oocysts

throughout dating

Eimeria

acervulina….600

Eimeria maxima

…...200 Eimeria

maxima MFP

……………………

.100

Eimeria

mivati……400

Eimeria

tenella…….200

(For Veterinary

Use).

12-Oct-12

Deposited

fee

100000

Balance Fee

Nil

DML No. 165A

Dated 10-2-

2011

Free Sale

Certificate No.

1102354

Dated 09-8-

2011

New

Molecule

45. ICI

Pakistan

Limited,

Karachi.

Schering-

Ploug Animal

Health

Limited.

Newzeland

COVEXIN 10

Clostridium

Vaccine for Sheef

Beef and Diary.

12-Oct-12

Deposited

fee

100000

Balance Fee

Nil

Prod Reg No.

A9028

Dated 23-5-

2011

GMP No

NZ262V/2010

Dated 23-3-

2011

New

Molecule

Minutes for 253rd


46. Hi-Tech

Pharmaceut

icals,

Lahore.

Pfizer Animal

Health (Pfizer

Inc), 2000

Rockford

Road, Charles

City, Iova,

USA.

Poulvac ® ST

Vaccine

Illustration of a

0.005ml dose

contains:-

Bacterial Culture….

≥3.0 x 107

CFU/Dose at

release

LP

Stabilizer…0.00125

ml Sterile

PBS…..0.00125ml

For Veterinary

Use).

29-Oct-12

Deposited

fee

100000

Balance Fee

Nil

U.S. Veterinary

License No.

190

Certificate No.

1302587

Indications

Salmonella

Mee too

confirmed

47. Hi-Tech

Pharmaceut

icals,

Lahore.

Pfizer Animal

Health (Pfizer

Inc), 2000

Rockford

Road, Charles

City, Iova,

USA.

Poulvac ® SE

Vaccine

Illustration of a

0.5ml dose

contains:-

Salmonella

enteritidis Phase

Type 4……….

…..RP….

≥1.0/dose at

release. Salmonella

enteritidis Phase

Type 8…RP………

…….≥1.0/dose at

release. Salmonella

enteritidis Phase

Type 13a…RP……

…….≥1.0/dose at

release.

37% Formaldehyde

Solution………0.0

006ml White

Oil……0.1995ml

Arlacel-

83…..0.1105ml

Tween-

80…..0.00168ml

Saline………q.s to

0.3ml For

Veterinary Use).

29-Nov-12

Deposited

fee

100000

Balance Fee

Nil

U.S. Veterinary

License No.

190

48. Mustafa

Brothers

Faisalabad.

Federal

Governmental

Budgetary

Institution

“Federal

Centre for

Animal

Dry Live vaccine

against Newcastle

disease from strain

La Sota.

Contains:-

One intranasal

(ocular) dose of the

6-Dec-12

Deposited

fee

15000

Balance Fee

Prod Reg No.

1047796296437

dated 11-8-

2011.

DML No. 0011-

1-001221 dated

Deffered

for strain

for

pakistani

Market By

following

experts

Minutes for 253rd


Health” (FGBI

“ARRIAH”,

Vladimir,

Russia.

vaccine contains at

least 6.7 1g

EID50/head of ND

vaccine strain

(strain La Sota)

(Vaccine).

85000

11-8-2011. Prof Dr

Khushi

Muhamma

d

Prof Dr

Masood

Rabani

Dr Arshad

Dr

Manzoor

(M-240)

Deffered

for

clarificatio

n of strain

and review

by already

constituted

committee

and

veterninary

experts

ofECBD.(

M-241) 49. Mustafa

Brothers

Faisalabad.

Federal

Governmental

Budgetary

Institution

“Federal

Centre for

Animal

Health” (FGBI

“ARRIAH”,

Vladimir,

Russia.

Virus Vaccine

against infectious

bursal disease from

BG strain

Contains:-

Infectivity of the

virus vaccine shall

be at least 104.5

EID50/cm3 One

dose of the vaccine

shall contain 103

EID 50

(Vaccine).

12-Jun-12

Deposited

fee

15000

Balance Fee

85000

Prod Reg No.

1047796296437

dated 11-8-

2011

DML No.00-

11-1-001221

dated 11-8-

2011

Check for

fee and Me

too status

50. Mustafa

Brothers

Faisalabad.

Federal

Governmental

Budgetary

Institution

“Federal

Centre for

Animal

Health” (FGBI

“ARRIAH”,

Vladimir,

Russia.

Vaccine against

infectious chicken

bronchitis from

strain “H-120” dry

live

Contains:-

One immunizing

vaccine dose

contains not less

than 104 EID50 of

IB virus (Strain H-

120) (Vaccine).

12-Jun-12

Deposited

fee

15000

Balance Fee

85000

Prod Reg No.

1023/30128372

0

Dated 26-7-

2011

GMP No.

1047796296437

Dated 26-12-

2011

Check for

fee and Me

too status

51. Mustafa

Brothers

Faisalabad.

Federal

Governmental

Budgetary

Associated Vaccine

Against Newcastle

Disease

12-Jun-12

Deposited

DML No. 00-

11-1-001220

Dated 11-8-

Check for

fee and

Mee too

Minutes for 253rd


Institution

“Federal

Centre for

Animal

Health” (FGBI

“ARRIAH”,

Vladimir,

Russia.

Infectious Chicken

Bronchitis and egg

drop syndrom-76

inactivated

emulsion

fee

15000

Balance Fee

85000

2011.

Free Sale

Certificate No.

N4-4056

Dated 11-10-

2011

status

52. Mustafa

Brothers

Faisalabad.

Federal

Governmental

Budgetary

Institution

“Federal

Centre for

Animal

Health” (FGBI

“ARRIAH”,

Vladimir,

Russia.

Virus vaccine

against Winterfield

Disease 2512 strain

(Missing)

12-Jun-12

Deposited

fee

15000

Balance Fee

85000

Prod Reg No.

1023301283720

Dated 26-7-

2011

GMP No. 0011-

1-001221

26-12-2011

Free Sale

Certificate No.

4-4078

Check for

fee and Me

too status

The Board was of the opinion that as per policy the products originating from the reference

countries shall be registered with peer review of valid CoPP and Free Sale Certificate issued by

the concerned regulatory body shall be preferred for registration.

Decision: Registration Board deliberated and deferred the case for technical opinion of



Minutes for 253rd


Case No. 05 Cases of Imported Products Of Human Biological Drugs Originating From

SRA Countries.

Registration Board considered following cases and decisions are recorded in last column. The

approval is subject to inspection of manufacturer abroad as per policy, verification of storage

facilities and price fixation / calculation by the Pricing Division.

S.#

.

Name of

Indenter/

Manufactu

rer

Manufactu

rer

Name of Drug

(s)/ Composition

& Therapeutic

Group

Date of

application /

Fee status

Documentar

y Details

Remarks Decision

1. GlaxoSmith

Kline

Pakistan

Limited,

Karachi.

GlaxoSmith

Kline

Biologicals,

S.A.

Belgium

Twinrix

Suspension for

injection (Pre-

filled) Each pre-

filled syringe

contains:-

Inactivated

Hepatitis A

virus…720

ELISA Units

Hepatitis B

surface antigen

(rDNA)......20

micrograms

(Combined viral

vaccine for

protection against

Hepatitis A and

B).

(For Human Use)

Date of

application

03.11.2010

Deposited Fee

15000+

35000

Balance Fee

Nil

EMA CoPP

No.

06/12/54421

Dated

23.5.2012

EU/1/96/020/

001-009

Dated

20.9.1996

New

Molecule

Recommen

ded ECBD

Deferred

for expert

opinion of

Gen ®

Karamat

Gen ®

Tasawar

Birg ®

Najmi Prof

Umar. (M-

240)

Registration

Board

deliberated

that it is an ir-

rational

formulation.

Thus the Board

rejected the

application.

2. Barrett

Hodgson

Pakistan

(Private)

Ltd

Allergan

Pharmaceut

icals

Ireland.

BOTOX 50 mg

Allergan Units

Powder for

solution for

Injection.

Date of

application

10.12.2010

Deposited Fee

15000+

35000

Balance Fee

Nil

CoPP No.

148/60/2.

GMP.2678

dated

31/10/2002.

Free Sale

Certificate

Indications

Botax 100

mg is

already

regisreted

under reg

N. 018959,

dated

07.4.1996

(M-118)

Deferred for

expert opinion

of Big.Dr.

Najmi and Dr.

Akhtar Saeed.

for newly

applied

strengths of 50

mg and 200 mg

Minutes for 253rd


3. Sind

Medical

Stores,

Karachi.

Bharat

Biotech

Internationa

l Limited,

Hyderabad,

Andhra

Pradesh,

India.

Biopolio

(Trivalent) Oral

solution (2ml

vial)

Each 1 dose =

0.1ml (2 drops)

contains:-

Polio virus

(Sabin)

-Type 1 > 106.0

CCID50

-Type 2 > 105.0

CCID50

-Type 3 > 105.5

CCID50

(Vaccine).

Date of

application

18.05.2011

Deposited fee

15000+

85000

Balance Fee

Nil

CoPP

No.16684/20

14/11/6551/2

8587 valid

till dated

17/03/2016

GMP No

2776/AB

(M#/T.S/201

4. Dated

16/09/2014.

Free Sale

Certificate.

9657/M3B/2

013. Dated

17/07/2013.

Indications

Polio

eradication

Me too,

252nd

Meeting

for EPI

As EPI has

recommended

registration of

formulation,

thus

registration

was

approved

4. Sind

Medical

Stores,

Karachi.

Bharat

Biotech

Internationa

l Limited,

Hyderabad,

Andhra

Pradesh,

India.

Biopolio B1/3

Oral solution

(2ml vial)

Each dose of

100ul (2 drops;

0.1ml) of the

vaccine contains:-

Polio virus

(Sabin)

-Type 1 > NLT

10 6.0 CCID50

-Type 3 > NLT

10 5.8 CCID50

(Vaccine)

Date of

application

18.05.2011

Deposited fee

15000+

85000

Balance Fee

Nil

CoPP

No.16684/20

14/11/6551/2

8587 valid

till dated

17/03/2016

GMP No

2776/AB

(M#/T.S/201

4. Dated

16/09/2014.

Free Sale

Certificate.

9657/M3B/2

013. Dated

17/07/2013.

Indications:

Polio

eradication

Me too,

252nd

Meeting

for EPI

As EPI has

recommended

registration of

formulation,

thus

registration

was

approved

5. Sind

Medical

Stores,

Karachi.

Bharat

Biotech

Internationa

l Limited,

Hyderabad,

Andhra

Biopolio M1 Oral

solution (2ml

vial)

Each dose of

100ul (2 drops;

0.1ml) of the

Date of

application

18.05.2011

Deposited fee

CoPP

No.16684/20

14/11/6551/2

8587 valid

till dated

17/03/2016

Me too,

252nd

Meeting

for EPI

As EPI has

recommended

registration of

formulation,

thus

registration

Minutes for 253rd


Pradesh,

India.

vaccine contains:-

Polio virus

(Sabin)

-Type 1 > NLT

106.0 CCID50

(Vaccine).

15000+

85000

Balance Fee

Nil

GMP No

2776/AB

(M#/T.S/201

4. Dated

16/09/2014.

Free Sale

Certificate.

9657/M3B/2

013. Dated

17/07/2013.

Indications

Polio

eradication

was

approved

6. Eastern

Trade &

Distribution

Co. (Pvt)

Ltd.,

Karachi.

CANGENE

CORPORA

TION,

Innipeg,

Manitoba,

Canada,

R3T 5Y3

WinRho ® SDF

Liquid Injection

Each 3ml vial

contains:- Anti-

Rho (D)…..600

IU (120mcg)/vial

Anti-Rhd

(D)…1500 IU

(300mcg)/vial

(Biologics).

Date of

application

17.08.2011

Deposited fee

100000

Balance Fee

Nil

CoPP No.

59723 dated

24/02/2015

validity 1

year

Product Lisc

No.02302578

. dated

16/06/2008.

Indications.

Anti-Rho (D

Product

Manufactur

er by

CANGEN

E

corporation

Manitoba,

Canada,

R3T 5Y3

confirmed

COPP

provided

No. 59723

from

Canada.

Approved

7. Popular

Internationa

l (Pvt) Ltd.,

Karachi.

Kedrion

S.p.A Loc.

Ai Conti,

Castelvecch

io Pascoli-

Barga

(LU), Italy.

Uman Albumin

Solution for

Infusion 250g/L-

50ml vial Each

50ml vial

contains:- Human

Plasma Proteins

containing at least

95%

Albumin……….1

2.5g (Plasma

Protein Solutions

(Human).

Date of

application

20.08.2011

Deposited fee

15000+

85000

Balance Fee

Nil

CoPP No.

NCCP

/2012/423

.

Product Reg

No.

021111087.

Dated

05/05/1984

Free Sale

Certificate

Indications.

(Plasma

Protein

deficiencies

(Human).

Recommen

ded by 4th

ECBD as

per SRA

Deferred

for

Clarificatio

n of

Similar

Formulatio

n in

Pakistan

Mee Too +

Firm has

submitted

clarificatio

n

(M-240),

Status in

Approved

Minutes for 253rd


252

Meeting

i. Reg No

007967

from

GRIFOLS

INC by

Popular

Internation

al.

8. Popular

Internationa

l (Pvt) Ltd.,

Karachi.

Kedrion

S.p.A Loc.

Ai Conti,

Castelvecch

io Pascoli-

Barga

(LU), Italy

Uman Albumin

Solution for

Infusion 200 g/L-

100ml vial Each

100ml vial

contains:- Human

Plasma Proteins

containing at least

95%

Albumin……….2

0g (Plasma

Protein Solutions

(Human).

Date of

application

20.08.2011

Deposited fee

15000+

85000

Balance Fee

Nil

CoPP No.

NCCP /2011

/ 1133

.

Product Reg

No.

02111101.

Dated

24/07/2002

Free Sale

Certificate

Indications.

(Plasma

Protein

deficiencies

(Human).

Recommen

ded by 4th

ECBD as

per SRA

Deffered

for

Clarificatio

n of

Simillar

Formulatio

n in

Pakistan

Mee

Too+Firm

has

submitted

clarificatio

n (M-240),

Status in

252

Meeting

i. Reg

No.023674

Human

Albumine

20% from

CSL

Bahring by

Hakimsons

ii. Reg No.

007967

Plasbmin-

20 from

Grifols

Therapeuti

cs

by Popular

Internation

al .

Approved

Minutes for 253rd


9. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Sandoz

GmbH

Biochemies

tr. Kundl,

Austria.

ZARZIO 30

MU/0.5ML PFS

Each PFS

contains:-

Filgrastim 30MU/

0.5ml

SOLUTION FOR

INFUSION or

INJECTION .

Date of

application

11.10.2011

Deposited fee

15000+

35000+

Balance Fee

85000

EMA CoPP

No.43015/09/

11/4833.

Dated

05/10/2011

Product Reg

No.

EU/1/08/495/

001-016.

Dated

06/02/2009.

Free Sale

Certificate

Indications.

Neutorpenia.

EMA and

US FDA

approved,

Bio-similar

product,

FDA

approved.

Approved.

10. Barrett

Hodgson

Pakistan

(Private)

Ltd

Allergan

Pharmaceut

icals

Ireland.

BOTOX 200 mg

Allergan Units

Powder for

solution for

Injection.

Date of

application

12.12.2011

Deposited fee

15000+

35000

Balance Fee

Nil

CoPP No.

148/60/2.

GMP.2678

dated

31/10/2002.

Free Sale

Certificate

Indications

New

Molecule Deferred

Product for

expert opinion

of Big.Dr.

Najmi and Dr.

Akhtar Saeed.

for newly

applied

strengths of 50

mg and 200 mg

Status

Deferred

11. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Sandoz

GmbH

Biochemies

tr. Kundl,

Austria.

Omnitrope

5mg/1.5ml

Solution for

Injection

Each cartridge

contains:- 1.5ml

corresponding to

5mg Somatropin

(15 IU)

(Growth

Hormones)

Date of

application

27.03.2012

Deposited fee

15000+

35000+

50000

Balance Fee

Nil

CoPP

No.43015/04/

1148232.05/1

0/2011

Product Lisc

No.EU/1/06/

332/004-012.

Dated

20/04/2007

Indications.

Growth

Hormones

deficiencies

EMA and

FDA

approved,

Biosimilar

product.

Approved.

Minutes for 253rd


12. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Sandoz

GmbH

Biochemies

tr. Kundl,

Austria.

Omnitrope

10mg/1.5ml

Solution for

Injection

Each cartridge

contains:- 1.5ml

corresponding to

10mg Somatropin

(30 IU)

(Growth

Hormones)

Date of

application

27.03.2012

Deposited fee

15000+

35000+

50000

Balance Fee

Nil

CoPP

No.43015/04/

1148232.05/1

0/2011

Product Lisc

No.EU/1/06/

332/004-012.

Dated

20/04/2007

Indications.

Growth

Hormones

deficiencies

EMA and

FDA

approved,

Biosimilar

product,.

Approved

13. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Sandoz

GmbH

Biochemies

tr. Kundl,

Austria.

ZARZIO 48

MU/0.5ML PFS

SOLUTION FOR

INFUSION OR

INJECTION

Date of

application

27.03.2012

Deposited fee

50000+

35000+

15000

Balance Fee

Nil

EMA

No.43015/09/

11/4833.

Dated

05/10/2011

Product Reg

No.

EU/1/08/495/

001-016.

Dated

06/02/2009.

Indications.

Neutorpenia.

EU

approved

Biosimilar

product,

FDA

approved.

Approved.

14. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Sandoz

GmbH

Biochemies

tr. Kundl,

Austria.

BINOCRIT

10000 IU/1ML

SOL FOR

INJECTION PFS

EPOETIN ALFA

84UG.1ML

Date of

application

27.03.2012

Deposited fee

15000+

35000+

50000

Balance Fee

Nil

EMA CoPP

No.08/11/482

35.

Dated

05/10/2011.

Product Reg

No.

EU//1/07/410

/001-052.

Indications:

anti cancer

EU

approved,

me-2,

Kundal

Austria,

Biosimilar

product,

FDA

approved.

Approved

15. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Sandoz

GmbH

Biochemies

tr. Kundl,

Austria.

BINOCRIT

4000IU/0.4ML

SOL FOR

INJECTION PFS

EPOETIN ALFA

33.6UG/ML

27.03.2012

Deposited fee

15000+

35000+

50000

EMA CoPP

No.08/11/482

35.

Dated

05/10/2011.

Product Reg

No.

EU

approved,

me-2,

Kundal

Austria,

Biosimilar

product,

Approved

Minutes for 253rd


Balance Fee

Nil

EU//1/07/410

/001-052.

Indications:

anti cancer

FDA

approved.

16. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Sandoz

GmbH

Biochemies

tr. Kundl,

Austria.

BINOCRIT

40000 IU/1ML

SOL FOR INJ IN

PFS

EPOETIN336UG

/1ML

27.03.2012

Deposited fee

15000+

35000+

50000

Balance Fee

Nil

EMA CoPP

No.08/11/482

35.

Dated

05/10/2011.

Product Reg

No.

EU//1/07/410

/001-052.

Indications:

anti cancer

EU

approved,

me-2,

Kundal

Austria,

Biosimilar

product,

FDA

approved.

Approved

17. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Sandoz

GmbH

Biochemies

tr. Kundl,

Austria.

BINOCRIT

1000IU/0.5ML

PFS

EPOETIN ALFA

27.03.2012

Deposited fee

15000+

35000+

50000

Balance Fee

Nil

EMA CoPP

No.08/11/482

35.

Dated

05/10/2011.

Product Reg

No.

EU//1/07/410

/001-052.

Indications:

anti cancer

EU

approved,

me-2,

Kundal

Austria,

Biosimilar

product,

FDA

approved.

Approved

18. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Sandoz

GmbH

Biochemies

tr. Kundl,

Austria.

BINOCRIT

2000IU/1 ML

PFS

EPOETIN ALFA

27.03.2012

Deposited fee

15000+

35000+

50000

Balance Fee

Nil

EMA CoPP

No.08/11/482

35.

Dated

05/10/2011.

Product Reg

No.

EU//1/07/410

/001-052.

Indications:

anti cancer

EU

approved,

me-2,

Kundal

Austria,

Biosimilar

product,

FDA

approved.

Approved

Minutes for 253rd


19. Merck

(Private)

Limited,

Quetta.

Merck

Serona S.A.

Succurale

D‟Aubonne

,

Switerzland

.

Luveris ® 75 IU

Powder for

injection

Each vial of

powder for

injection

contains:-

75 IU (3.0

Micrograms) of

Lutropin Alfa

(Recombinant

Human

Iuteinising

Hormone) (r-

hLH)

(Gonadotropins)

24.04.2012

Deposited fee

15000.

Balance Fee

85000

EMA CoPP

No.

06/11/48772.

Dated

09/12/2011.

Prod Reg No.

EU/1/00/155/

001-006.

Dated

29/11/2000.

Indications.

Hormone

replacement

therapy.

New

Molecule Deferred for

confirmation of

balance fee and

expert opinion

of Gynecologist

Dr. Ghazala,

PIMS,

Islamabad and

Dr. Seyada

Batool Mazhar,

PIMS,

Islamabad

20. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Manufactur

ed by

Sanofi -

Anantus

Germany

Licence

holder

Sanofi -

Avantes

USA

Exporting

Countary

(Germany)

ZALTRAP

AFLIBERCEPT

25MG/ML +

CONCENTRATE

SOLUTION FOR

INFUSION

200/8.0ML

(NOMINAL

CONCENT)

29.03.2013

Deposited fee

100000

Balance Fee

Nil

EMA CoPP

No.02/14/744

33. Dated10/

01/2013

Prod Reg

No.

EU/1/12/814/

003,

Dated.13/03/

2014.

Indications

Anticancer.

US FDA

approved

EMA

approved.

Me too

confirmed

Approved

21. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Manufactur

ed by

Sanofi -

Anantus

Germany

Licence

holder

Sanofi -

Avantes

USA

Exporting

Countary

(Germany)

ZALTRAP

25MG/ML

AFLIBERCEPT

25MG/ML

CONCENTRATE

SOLUTION FOR

INFUSION

100/4.0ML

(NOMINAL

CONCENT)

29.03.2013

Deposited fee

100000

Balance Fee

Nil

EMA CoPP

No.02/14/744

32.

Dated

13/03/2014

Prod Reg

No.

EU/1/12/814/

003,

Dated.01/02/

2013.

Indications

Anticancer

US FDA

approved

EMA

approved.

Me too

confirmed

Approved

Minutes for 253rd


22. PFIZER

Pakistan

Limited,

Karachi./

Pfizer

Canada Inc.

Saint-

Laurent,

Quebec,

Canada.

Premarin Vaginal

Cream Each gram

of the cream

contains:-

Conjugated

Estrogens………

0.625mg

(Repelacement

hormone,

Antineoplastic,

Antiosteoporotic).

07.06.2013

Deposited fee

100000

Balance Fee

Nil

Health

Canada

Prod Lisc.

No.

02043440.

Dated

31/12/1994.

FDA ref No.

FEI30028064

39.

Indications.

Replacement

hormone,

Me too Deferred

Referred for

expert opinion

of Gynecologist

Dr. Ghazala,

PIMS,

Islamabad and

Dr. Syada

Batool Mazhar,

PIMS,

Islamabad

23. Hakimsons

(Impex)

Pvt.

Limited,

Karachi.

CSL

Behring

AG

Wankdorfst

rasse ,Berns

Switzerland

.

Albu Rx 100 ML

HUMAN

ALBUMIN 20 %

12.08.2013

Deposited fee

50000+

50000

Balance Fee

Deposited on

01/09/2015.

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

New

Molecule,

Approved

in USA

Germany,

Switzerlan

d And EU,

New

Molecule

confirmatio

n

Approved

24. Hakimsons

(Impex)

Pvt.

Limited,

Karachi.

P.T Bio

farma

(Persero)

Jalan

Pasteur,Ban

dung

Indonesia.

BIVALENT

ORAL

POLIOMYELITI

S VACCIN

1VIAL

BIOVALENT

ORAL

POLIOMYELITI

S VACCINE

TYPE 1&3

10.10.2013

Deposited fee

50000

Balance Fee

Nil

CoPP No

PN.01.05.31.

313.05.10.44

2. Dated

25/05/2010

validity10

yrs.

Indications.

Polio

Eradication.

New

Molecule,

WHO

Approved,

New

Molecule

confirmatio

n

Approved

25. Novo

Nordisk,

Karachi.

Novo

Nordisk

A/S

Denmark.

TRESIBA

FLEXTOUCH

200UNIT/ML

INSULIN 03 PF

SYRINGS

FLEXTOUCH

DEGLUDEC PFP

CONTAIN 1200

NMOL

17.12.2013

Deposited fee

50000

Balance Fee

Nil

GMP by

Danish

Health &

Med

Authority.

EMA CoPP

04/15/89702.

Dated

15/07/2015.

Prod reg No.

EU/1/ 12/

807/013.

Dated

21/01/2013

Indication

Diabetis.

NEW

MOLECU

LES, CoPP

EMA

Approved

Minutes for 253rd


26. Novo

Nordisk,

Karachi.

Novo

Nordisk

A/S

Denmark.

TRESIBA

PENFILL 100

UNIT/ML

INSULIN

DEGLUDEC

05 CARTRIDGE PENFILL FOR

INJ

600 NMOL

30.1.2014

Deposited fee

50000

Balance Fee

Nil

GMP by

Danish

Health &

Med

Authority.

EMA CoPP .

03/15/90807.

Dated

07/08/2015.

Prod reg No.

EU/1/ 12/

807/007.

Dated

21/01/2013

Indication

Diabetis.

NEW

MOLECU

LES, CoPP

EMA

Approved

27. Novo

Nordisk,

Karachi.

Novo

Nordisk

A/S

Denmark.

RYZODEG

FLEXTOUCH

SOLUTION FOR

INJECTION

INSULIN

DEGLUDEC/INS

ULIN ASPART

(420

DEGLUDEC +

180 ASPART)

05PF SYRINGES

(FLEXTOUCH)

100 UNIT/ML

17.12.2013

Deposited fee

50000

Balance Fee

Nil

GMP by

Danish

Health &

Med

Authority.

EMA CoPP

03/15/89703.

Dated15/07/2

015.

Prod reg No.

EU/1/12/806/

004. Dated

21/01/2013.

Indication.

Diabetes

NEW

MOLECU

LES,

CoPP

EMA

Approved

28. Hakimsons

(Impex)

Pvt.

Limited,

Karachi.

CSL

Behring

AG

Wankdorfst

rasse ,Berns

Switzerland

.

PRIVIGEN

2.5G/25ML

BOTTLE

HUMAN

NORMAL

IMMUNOGLOB

ULIN

02.01.2014

Deposited fee

50000

Balance Fee

Nil

Swiss Medic

CoPP

No.12005530

Dated

15/09/2011.

Prod Lisc

No.5831401.

Dated

19/03/2010.

No.

Indications.

Immunodefic

iency

syndrome.

Leukemia.

Congenital

AIDS.

New

Molecule,

Approved

in USA

Germany,

Switzerlan

d And EU

Deferred for

expert opinion

of Brig.

Mukaram

Bashir, AFIP,

Rawalpindi

and Brig. Dr.

Tahir Aziz,

AFIP,

Rawalpindi

Minutes for 253rd


29. Novo

Nordisk,

Karachi.

Novo

Nordisk

A/S

Denmark.

TRESIBA

FLEXTOUCH

100UNIT/ ML

SOL FOR INJ

05 PF

SYRINGES

FLEXTOUCH

PFP CONTAIN

600NMOL

17.12.2013

Deposited fee

50000

Balance Fee

Nil

CoPP No.

05/15/89701

Dated 15-07-

2015

Prod Reg No.

EU/1/12/807/

004

Dated 21-1-

2013

Indications

Dibeties

NEW

MOLECU

LES, CoPP

EMA

Approved

30. Novo

Nordisk,

Karachi.

Novo

Nordisk

A/S

Denmark.

RYZODEG

PENFILL

100UNIT ML

SOL FOR INJ

05

CARTRIDGE PENFILL

CONTAIN 600

UNITS NMOL

OF (420

DEGLUDEC

+180 ASPART

INSULIN)

30.01.2014

Deposited fee

50000

Balance Fee

Nil

CoPP No.

02/15/89704

Dated 15-7-

2015

Prod Reg No.

EU/1/12/806/

007 Dated

21-1-2013

Indications

Diabetes

NEW

MOLECU

LES, CoPP

EMA

Approved

31. Roche

Pakistan

Limited, 37-

C, Block 6,

PECHS,

Karachi/

F.

Hoffmann-

La Roche

Ltd, Basel,

Switzerland

Roche

Diagnostic,

Mannheim

Germany.

PERJETA

CONCENTRATE

FOR SOLUTION

FOR INFUSION.

Each vial

contains:-

420MG/14ML

PERTUZUMAB

25.02.2014

Deposited fee

100000

Balance Fee

Nil

EMA CoPP

No.13/13/654

22

Dated

24.5.2013

Prod Reg No.

EU/1/13/813/

001

Dated

04.3.2013

Indications

Anti Cancer

Monoclonal

Antibody

New

Molecule

FDA EMA

Approved

Deferred for

expert opinion

of Maj. Gen,

Naeem Naqvi,

CMH, Lahore,

Brig. Iftikhar

and Dr.

Saleema

Siddique, Shifa

Hospital ,

Islamabad

32. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Sanofi

Pasteur,

SA, Lyon,

France.

INSUMAN comb

30 100 IU/ml

Suspension for

Injection.

5 cartridges of

3ml

01.04.2014

Deposited fee

100000

Balance Fee

Nil

EMA CoPP

No.02/13/663

76. Dated

18/06/2013.

Prod Reg No

EU/01/97/

030 / 174,

Dated

19/02/2009

Indications.

Diabetes.

EMA

Approved Approved

Minutes for 253rd


33. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Sanofi

Pasteur,

SA, Lyon,

France.

INSUMAN

COMB 30

100IU/ML

SUSPENSION

FOR INJ 1VIAL

OF 5ML

01.04.2014

Deposited fee

100000

Balance Fee

Nil

EMA CoPP

No.03/13/663

75.

Dated

18/06/2013.

Prod Reg No

EU/01/97/

030 / 170.

Dated

03/07/2012

Indications.

Diabetes.

EMA

Approved Approved

34. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Sanofi

Pasteur,

SA, Lyon,

France.

INSUMAN

COMB

30/100IU/ML

VIAL

SUSPENSION

FOR INJ 1VIAL

OF 10ML

01.04.2014

Deposited fee

100000

Balance Fee

Nil

EMA CoPP

No.

03/13/66375.

Dated.18/06/

2013

Prod reg No.

EU/1/97/030/

200. Dated

03/07/2012.

Indications

Diabetes

EMA

Approved Approved

35. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Vetter

Pharma

Fertigun

ng Gmbh &

Co. KG

Langenarg.

Germany.

Lucentis

Ranibizumab,

Pre Filled

Syringes

20.06.2014

Deposited fee

50000

Balance Fee

50000

EMA CoPP

09/14/75812

Dated

22.4.2014

Prod Reg No.

EU/01/06/37

4/003

Dated

24.10.2013

Indications

Anti Cancer

Monoclonal

Antibody

New

Molecule

Fee

confirmatio

n

Deferred for

expert opinion

of Maj. Gen,

Naeem Naqvi,

CMH, Lahore,

Brig. Iftikhar

and Dr.

Saleema

Siddique, Shifa

Hospital ,

Islamabad

36. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Vetter

Pharma

Fertigun

ng Gmbh &

Co. KG

Langenarg.

Germany.

XOLAIR 75MG

Prefilled Syringes

Omalizumab

09.02.2015

Deposited fee

50000

Balance Fee

CoPP No.

02/15/84060

Dated 16-1-

2015

Prod Reg No

EU/1/05/319/

EMA

CPP,GMP

CERTIFIC

ATE.

Deferred due to

paucity of time.

Minutes for 253rd


50000 005/010

Dated 10-2-

2009

Indications

Treatment of

Chornic

Spontaneous

Urticaria

(CSU)

37. Lilly

Pakistan,

Karachi.

Lilly

France

Basaglar 100

units/ml

Kwik Pen

Lilly France

09.02.2015

Deposited fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Bio

Similar,

EMA

Deferred due to

paucity of time.

38. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Novartis

Pharma

Switzerland

.

Cosentyx 150mg

Vial ,

Powder for

solution fro

injection

11.02.2015

Deposited fee

50000

Balance Fee

Nil

CoPP No.

01/15/84304

Dated 28-1-

2015

Prod Reg No.

EU/1/14/980/

001

Dated 15-1-

2015

Indications.

Treatment of

moderate-to-

severe plaque

psoriasis

EU,EMA

CPP,GMP

CERTIFIC

ATE.

New

Molecule.

Deferred due to

paucity of time.

39. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Novartis

Pharma

Switzerland

.

Cosentyx 150mg

Pre-filled syringe

11.02.2015

Deposited fee

50000

Balance Fee

Nil

CoPP No.

01/15/84317

Dated 28-1-

2015

Prod Reg No.

EU/1/14/980/

002-005

Dated 15-1-

2015

Indications.

Treatment of

moderate-to-

severe plaque

psoriasis

EU,EMA

CPP,GMP

CERTIFIC

ATE.

New

Molecule.

Deferred due to

paucity of time.

Minutes for 253rd


40. Lilly

Pakistan,

Karachi.

Lilly

France

Basaglar 100

units/ml

Cartridge

Lilly France

23.02.2015

Deposited fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Bio

Similar,

EMA

Deferred due to

paucity of time.

41. Lilly

Pakistan,

Karachi.

Lilly USA Trulicity

0.75mg/0.5ml

Single Dose Pen

Lilly USA.

05.03.2015

Deposited fee

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

New

Molecule

FDA

Aproved

Deferred due to

paucity of time.

42. Lilly

Pakistan,

Karachi.

Lilly USA Trulicity

01.5mg/0.5ml

Single Dose Pen

Lilly USA.

05.03.2015

Deposited fee

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

New

Molecule

FDA

Aproved

Deferred due to

paucity of time.

43. OBS

Pharma

(Pvt) Ltd.,

Karachi. /

Merck

Sharp &

Dohme

Corp, US,

Sumneytow

n Pike,

West Point,

PA

USA.

ROTATEQ Oral

Solution 2ml I

Rotavirus

Vaccine,Live,

Oral Pentavalant

1 Single Dose

Tube.

20.03.2015

Deposited fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Me too Deferred due to

paucity of time.

44. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Genzyme

Ireland Ltd

IDA

Industrial

Park Old

Kilmeaden

Road

Waterford,

Ireland.

Imported

Countary

(United

Kingdom)

MYOZYME

(ALGLUCOSID

ASE ALFA)

Genzyme

Flanders bvba

Cipalstraat 8

9/6/2015

Deposited fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

New

Molecule,

Compositio

n

Confirmati

on

Deferred due to

paucity of time.

Minutes for 253rd


45. Sanofi-

aventis

Pakistan

Limited,

Karachi.

SHAN - 5

Diptheria,

Tetanus, Bivalent

Pertussis,

Hepititus B and

Haemophilus

Influenzae Type b

Conjugate

Vaccine

(adsorbed)

03.06.2015

Deposited fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Re-

confirmatio

n from the

company

as similar

name

products

are already

approved.

Deferred due to

paucity of time.

46. Genesis

Pharmaceuti

cals (Pvt)

Ltd, Lahore

Cantt./

Stichting

Sanquin

Bloedvoorz

iening

Plesmanlaa

n,

Amsterdam

, The

Netherlands

. Marketing

Authorizati

on Holder:-

Oxbridge

Pharma

Ltd. United

Kingdom.

Aragam 50mg

Solution for

Infusion

Human Normal

Immunoglobulin

……..50mg/ml

Deposited fee

15000

Balance Fee

Check fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

Documents

confirmatio

n

Deferred due to

paucity of time.

47. Amtul

Pharmaceuti

cals,

Lahore. /

.

CP

Pharmaceut

icals Ltd.

Wrexham

Industrial

Estate, Ash

Road

North,

Wrexham,

United

Kingdom

D-Clot Heparin

Sodium Injection

5000 IU/5ml Vial

Each 5ml

contains:-

Heparin

Sodium……….50

00 iu (Heparin

/Anticoagulant).

No Data

Date of

application

Deposited fee

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

Documents

confirmatio

n

Deferred due to

paucity of time.

Minutes for 253rd


48. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Sanofi

Pasteur,

SA, Lyon,

France.

Vivaxim*-

Suspension and

Solution for

injection in a

Prefilled dual-

chamber syringe

Each dose of

reconstituted

vaccine (1ml)

contains:-

Vi capsular

polysaccharides

of Salmonella

typhi (Ty2

strain)…….25

micrograms)

Hepatitis A virus,

GBM strain*

(inactivated**)…

….160 units***

(Bacterial and

Viral Vaccine)

No Data

Date of

application

Deposited fee

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

Recommen

ded by

ECBD. RB

Deferred

for expert

opinion of

Gen ®

Karamat

Gen ®

Tasawarn

Birg ®

Najmi.

Prof Umar

Deferred due to

paucity of time.

49. Novity

Pharma

Distributors,

Lahore./

SuperGener

ics, Inc.

Phoenix,

AZ, USA.

C-Vaxin Injection

Each injection

contains:-

Hepatist C

Vaccine…….50m

cg (……………..)

No Data

Date of

application

Deposited fee

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

The board

deferred

these cases

and

advised to

get

clarificatio

n/

justificatio

n from the

applicant

about

sources of

API,

product,

details and

statements

on

company's

website.

Complete

confirmaio

n of

documents

needed.

Deferred due to

paucity of time.

Minutes for 253rd


50. RG

Pharmaceuti

ca (Pvt)

Ltd.,

Karachi-

75400.

Laboratorie

s EFFIK,

France.

Manufactur

ed by:

Capsugel

(Pfizer

Group)

Ploermel-

France.

Progeffik 100mg

Soft Gel Capsule

Each Soft Gel

Capsule

contains:-

Progesterone……

…..100mg

(Genito-Urinary

system and sexual

hormones).

Date of

application

Deposited fee

15000

Check

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

The firms

claims that

they have

already

registered

product. It

is proposed

to check

their

registration

process.

Deferred due to

paucity of time.

51. RG

Pharmaceuti

ca (Pvt)

Ltd.,

Karachi-

75400.

Laboratorie

s EFFIK,

France.

Manufactur

ed by:

Capsugel

(Pfizer

Group)

Ploermel-

France.

Progeffik 200mg

Soft Gel Capsule

Each Soft Gel

Capsule

contains:-

Progesterone……

…..200mg

(Genito-Urinary

system and sexual

hormones).

Date of

application

Deposited fee

15000

Check

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

The firms

claims that

they have

already

registered

product. It

is proposed

to check

their

registration

process.

Deferred due to

paucity of time.

52. RG

Pharmaceuti

ca (Pvt)

Ltd.,

Karachi-

75400.

Cerbios-

Pharma SA

Barbengo/L

ugano,

Switzerland

.

NewFlora

Capsule Each

capsule contains:-

75 million

Enterococcus

faecium …SF68,

per capsule

Excipients

Lactose, Excip.

Pro gelatin caps.

(ATC code:

A07FA01)

No Data

Date of

application

Deposited fee

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

The firms

claims that

they have

already

registered

product. It

is proposed

to check

their

registration

process.

Deferred due to

paucity of time.

53. FK Pharma

Lahore.

LFB

Biomedica

ments

Courtaboue

f Cedex,

France

Vialebex

Injection Each

vial contains:-

Serum Human

Albumin

20%................100

ml

(Biological Blood

Fractions).

No Data

Date of

application

Deposited fee

Check

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

General

Decision Deferred due to

paucity of time.

Minutes for 253rd


54. FK Pharma

Lahore.

Exporter

Avenir

Pharma and

Manufactur

ed :

Labtech

Pharma

S.A.

Geneva,

Switzerland

.

Immunoplex-N

Sublingual

Tablets

Each tablets

contains:-

Interferon alpha

2b…………….20

0 i.u (Anti-viral).

No Data

Date of

application

Deposited fee

Check

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

The board

after

discussion

decided to

refer back

to ECBD

for re-

evaluation

and

preparation

of detailed

report for

considerati

on of

Registratio

n Board.

Deferred due to

paucity of time.

55. Martin Dow

Pharmaceuti

cals

Limited,

Karachi.

Laboratorio

Italiano

Biochimico

Farmaceuti

co S.P.A

Italy

Calco 100IU

Ampoule Each

ampoule contains:

- Salmon

Calcitonin

…100IU

(Calcium

Regulatory)

No Data

Date of

application

Deposited fee

Check

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

04th ECBD

Deferred

for

confirmatio

n of

documents

Deferred due to

paucity of time.

56. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Sanofi

Pasteur,

SA, Lyon,

France.

INSUMAN

COMB 30

100IU/ML SUSP

SUSPENSION

FOR INJECTION

Date of

application

Deposited fee

100000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

Deferred due to

paucity of time.

57. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Sanofi

Pasteur,

SA, Lyon,

France.

INSUMAN

COMB 25

100IU/ML

SUSPENSION

FOR INJECTION

Date of

application

Deposited fee

15000

Check

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

Deferred due to

paucity of time.

Minutes for 253rd


58. Sanofi-

aventis

Pakistan

Limited,

Karachi.

Sanofi

Pasteur,

SA, Lyon,

France

INSUMAN

BASAL

100IU/ML

SUSPENSION

FOR INJECTION

Date of

application

Deposited fee

15000

Check

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

Deferred due to

paucity of time.

59. GlaxoSmith

Kline

Pakistan

Limited,

Karachi.

GlaxoSmith

Kline

Biologicals,

S.A.

Belgium

NIMENRIX

VACCIN

MENINGOCOC

CAL

Date of

application

Deposited fee

50000

Check

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

Product

compositio

n

confirmatio

n

Deferred due to

paucity of time.

60. GlaxoSmith

Kline

Pakistan

Limited,

Karachi.

GlaxoSmith

Kline

Biologicals,

S.A.

Belgium.

POLIORIX

VACCINE

40D ANTIGEN

UNITS OF TYPE

1 (MAHONEY),

8D ANTIGEN

UNITS OF TYPE

2 (MEF-1) AND

32D (SAUKETT)

Date of

application

Deposited fee

15000

Check

Balance Fee

CoPP No.

DML No.

Free Sale

Certificate

Indications

Status

confirmatio

n from the

company

Deferred due to

paucity of time.

61. Roche

Pakistan

Limited, 37-

C, Block 6,

PECHS,

Karachi/

F. Hoffman

-La Roche

Ltd, Basel

Switzerland

Kadcyla Vial

Each vial

contains:-

Trastuzumab

Emtansine

(Powder)…...100

mg

20mg/ml after

reconstitution

Breast cancer

(Anti-cancer)

09.06.2015

Deposited fee

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

EMA

APPROVE

D, New

Molecule,

Strength

reconfirmat

ion,,, two

products

Deferred due to

paucity of time.

62. Roche

Pakistan

Limited, 37-

C, Block 6,

PECHS,

Karachi/

F. Hoffman

-La Roche

Ltd, Basel

Switzerland

Kadcyla Vial

Each vial

contains:-

Trastuzumab

Emtansine

(Powder)…...100

mg

20mg/ml after

reconstitution

Breast cancer

(Anti-cancer)

09.06.2015

Deposited fee

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

EMA

APPROVE

D, New

Molecule,

Strength

reconfirmat

ion,,, two

products

Deferred due to

paucity of time.

Minutes for 253rd


63. Ali Gohar

& Co,

Karachi

Patheon

UK Ltd,

Kingfisher

Drive

Covin

Gham

Swindon

Wiltshire

Uk

Jetrea solution for

Injection

Each vial

contains:-

Ocriplasmin….0.

5mg/ 0.2ml

For

Vitreomacular

traction

(rDNA )

Date of

application

10.06.2013

Deposited fee

50000

Balance Fee

Nil

CoPP No.

DML No.

Free Sale

Certificate

Indications

EMA

APPROVE

D, New

Molecule

Deferred due to

paucity of time.

64. Novartis

Pharma

(Pakistan)

Limited,

Karachi./

Novartis

Pharma

Switzerland

.

Cosentyx 150mg

Pre-filled Pen Date of

application 11.02.2015

Deposited fee

50000

Balance Fee

Nil

CoPP No.

01/15/84316

Dated 28-1-

2015

Prod Reg No.

EU/1/14/980/

002-005

Dated 15-1-

2015

Indications

Treatment of

moderate-to-

severe plaque

psoriasis

EU,EMA

CPP,GMP

CERTIFIC

ATE.

Ne

Molecule.

Deferred due to

paucity of time.

Minutes for 253rd


Case No. 06. Miscellaneous Cases

Case No. a Pending cases of 249th

meeting of Registration Board related to M/S.

Vetline International, Lahore.

The following applications of veterinary biological drugs were placed before the Board in

its 249th

, 250th

and 251st Meeting of the Registration Board.

S.No

.

Name of

applicant and

name of

exporter

Name of drug and its

composition

Date of

applicatio

n

Applicatio

n form

and Fee

Pack size Shelf life

1. Vet line

International

Lahore

License Holder

Laprovet

Hungary

Veterinay

Pharmaceutical

s Ltd.

Hungary,

Manufactured

by

Ceva-Phylaxia

Hungary with

manufacturing

contract with

Lapro vet

France.

ITA NEW (ND)

Each dose contains:-

Inactivated Newcastle

disease virus (NDV-

SZ) LaSota

strain………………

…..

Min 50PD50

24.06.2010 Form 5 A

Rs.

100,000

Mee too

status

confirmed

i. Reg

No.044901

GALLAMI

NE ND

Injection

by Marush

from

Marial

Italy

1000

doses vial

2 years

2. Vet line

International

Lahore

License Holder

Laprovet

Hungary

Veterinay

Pharmaceutical

s Ltd.

Hungary,

Manufactured

by

Ceva-Phylaxia

Hungary with

manufacturing

contract with

AVI POX

Live, freeze dried fowl

pox vaccine


Fowl pox virus, cutter

strain min. 102‟7

EID50

(Live vaccine)

24.06.2010 Form 5 A

Rs.

100,000

Mee too

status

confirmed

i.

POXIMUN

E Injection

Reg No.

035031 by

Biomune

company

USA

1000

doses vial

30months

Minutes for 253rd


Laprovet

France.

marketed

Better

Traders

Faisalabad

3. Vet line

International

Lahore

License Holder

Laprovet

Hungary

Veterinay

Pharmaceutical

s Ltd.

Hungary,

Manufactured

by

Ceva-Phylaxia

Hungary with

manufacturing

contract with

Lapro vet

France.

AVI-

ND LASOTA + IB


Newcastle disease

virus LaSota

strain…Min

105.5

EID50

Infectious bronchitis

virus B-48

strain…..Min

102.6

EID50

(Live vaccine)

ITEM NO.

VICASEOF M/s.

GRATON

PHARMA,

KARACHI FOR

THE

REGISTRATION

OF INTERFERON

ALFA 2B 3000IU

/VIAL (LIPHERON

FROM BEIJING

SHANGLU, CHINA)

The firm M/s.

Graton Pharma,

Karachi has informed

that they applied for

the registration of

Interferon Alfa 2b

300MIU injections

22.6. 2011 but their

application has not

been considered in any

meeting till date .The

firm has provided

evidence of

documents and fee

challans submitted by

them.

2. The case of the

24.06.2010 Form 5 A

Rs.

100,000

Mee too

status

confirmed

i. BIOVAC

ND IB

VACCINE

by Well

Pharma

Lahore

(NEUVA

VETERIN

ARY

BIOLOGI

CAL,

ITALY

Reg No.

018806.

ii. CEVA

NB Reg

No, 023401

by Marush.

iii.

EVIPRO

ND IB

SOHOL

Reg No.

011073 by

Lohman

Germany

(Golden

Harvest)

1000

doses vial

18months

Minutes for 253rd


The Registration Board in its 251st Meeting decided as under;

firm belongs to pre

devolution at the time

to Drugs Control

Organization, Ministry

of Health. The section

tried to retrieve the

application from old

record but still the

record is not found.

Copy of GMP shows

its validity till

14.03.2015. Copy of

CoPP has also been

provided by the

company.

Decision of the

Board: The

Board deferred the

case for completion

of documents by the

firm and to present

the case with all

available details in

the next meeting of

Registration Board.

4. Vet line

International

Lahore

License Holder

Laprovet

Hungary

Veterinay

Pharmaceutical

s Ltd.

Hungary,

Manufactured

by

Ceva-Phylaxia

Hungary with

manufacturing

contract with

Lapro vet

France.

AVI IBD PLUS


IBD virus Winterfield

2512, G-61 strain,

min. 2.0 log 10 EID50

(Live vaccine)

29.06.2010 Form 5 A

Rs.

100,000

Mee too

status

confirmed

i.

CALAVA

C

GUMBOR

O PLUS

Reg

No.043517

from CA

Lab

Venzvella

by Khyber

Poultry

Faisalabad.

500,1000

and 2500

doses vial

24months

Minutes for 253rd


Decision 251st Meeting : The Board deferred the case and advised firm to provide evidence/free

sale certificate/CoPP clearly indicating all the manufacturing sites involved in the

manufacturing process, issued by the regulatory authority of Hungary, duly notarized/ legalized

by embassy of Pakistan in Hungary. Moreover, Dr. Amanullah Khan, Director DTL, Quetta

requested to share above registration applications with him before further processing of the

case.

The firm has submitted notarized, legalized and attested required documents by Pakistan

Embassy, Budapest Hungry. The letter is issued by Veterinary Drugs Controlling Authority

(National Food Chain Safety Office, Directorate of Veterinary Medicinal Products, Budapest

Hungary) certifying that Laprovet Hungary Veterinary Pharmaceuticals Ltd. 1107 Budapest,

Horog u. 32-34. Hungary (Wholly owned and subsidiary of Laprovet, France) is licensed to

manufacture veterinary biologicals. List of fully registered and freely sold vaccines are

exclusively contract manufactured in Hungary by CEVA-PHYLAXIA Hungary. List of vaccine

in the letter includes above mentioned four vaccines. The complete copy of set of dossiers is also

available for sharing with member registration board Dr. Amanullah Khan as per decision of the

Board please.

Decision: Registration Board deliberated and deferred the case for technical opinion of



Case No. b. Registration of drugs of M/s. Excel Pharma-Inspection abroad already

conducted

M/s Excel Health Care, Karachi has applied for registration of their following products. The

company has deposited an amount of Rs 100,000/- against each product: -

S.#. Applicant

Product

Specifications

Exporting Company Inspection abroad

report

Team Members

Mr. Adnan Faisal

Saim (DDC)

Mr. Asif Jalil

(ADC)

1. Excel Health

Care

Laboratories

(Pvt) Ltd,

Karachi

MENSTROL

tablets (Levonorgestrel

0.5 mg

Estradiol 2mg)

Furen Pharmaceutical

Group Co., Ltd, China

Recommended by the

panel

2. Excel Health Care

Laboratories (Pvt) Ltd,



Recommended by the

panel

Minutes for 253rd


Karachi FEMININ tablets (Cyproterone

Acetate 2mg &

ethinyloestradiol

35mcg)



Karachi

MENOCARE

tablets (Estradiol valerate

2mg and cyproterone

acetate 1mg)



Recommended by the

panel



Karachi

ANDROL tablets (Cyproterone

Acetate 50mg)



Recommended by the

panel



Karachi

GESTON INJ (Natural

Progesterone

50mg/ml)


Group Co., Ltd, China Injectable facility

was separate and

under construction.

Not recommended

by the panel.



Karachi

GONACOR INJ

2000IU (Human Chorionic

Gonadotropin)

Yantai Beifang

Pharmaceutical Co.,

Ltd. China

Recommended by the

panel



Karachi

GONACOR INJ (Human Chorionic

Gonadotropin

5000IU)

Yantai Beifang

Pharmaceutical Co.,

Ltd. China

Recommended by the

panel



Karachi

HMG MASSONE (Human Menopausal

Gonadotropin 75IU)

Yantai Beifang

Pharmaceutical Co.,

Ltd. China

Recommended by

the panel. However

the panel has given

composition as FSH

75IU +LH 75IU



Karachi

HMG MASSONE (Human Menopausal

Gonadotropin

150IU)

Yantai Beifang

Pharmaceutical Co.,

Ltd. China

Recommended by

the panel. However

the panel has given

composition as FSH

150IU +LH 150IU



Karachi

MENORIN 0.3mg (Conjugated

Estrogen)

Xinjiang Nuziline Bio-

pharmaceutical Co.,

Ltd. China

Recommended by the

panel.



Karachi

ENDRALIN (Alarelin 150ug-Gnrh)

Maa‟nshan Fengyuain

Pharmaceutical Co.,

Ltd Chian

Recommended by the

panel.



Karachi

LUTRONE INJ

100UG (Gonadorelin 10‟s)


Pharmaceutical Co.,

Ltd China.

Recommended by the

panel.

Minutes for 253rd


The policy of advance parallel inspection was discussed in 237th

Meeting of Registration Board;

however, the policy was revised in 238th

Meeting of Registration Board. Meanwhile, the inspection

abroad was conducted which is summarized above. Earlier the case was placed in 244th

Meeting of

Registration Board where in it was decided that the case is in complete and should be processed

through ECBD.

Registration Board in its 249th

Meeting directed the Biological Division to evaluate the submitted

dossiers of products including resemblance of brand names.

The evaluation is tabulated as below;

S. No. Product Specifications

Exporting Company Inspection abroad

report

Team Members

Mr. Adnan Faisal

Saim (DDC)

Mr. Asif Jalil

(ADC)

Evaluation by the

Directorate of

Biological Drugs

1. MENSTROL tablets (Levonorgestrel

0.5 mg

Estradiol 2mg)



Recommended by the

panel

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated due to non

decision from so

many years. The

firm has pledged to

provide valid

documents before

the issuance of


The product is also

combo packed with

plain Estradiol 2mg

tablets which is not

mentioned in CoPP

or FSC. Similar

product is already

registered in the

name of M/s.

Schering AG,

Karachi having

plain Estradiol 2mg

tablets.

Minutes for 253rd


2. FEMININ tablets (Cyproterone Acetate 2mg

& ethinyloestradiol

35mcg)



Recommended by the

panel

Mee too, similar

formulation of

Schering AG is

already registered

with Brand name

Diane-35

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated due to non

decision from so

many years. The

firm has pledged to

provide valid

documents before

the issuance of


3. MENOCARE tablets (Estradiol valerate 2mg and

cyproterone acetate 1mg)



Recommended by the

panel

Mee too, similar

product Climen is

already registered in

the name of M/s.

Schering AG,

Karachi having plain

Estradiol 2mg tablets.

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated due to non

decision from so

many years. The

firm has pledged to

provide valid

documents before

the issuance of


The product is also

combo packed with

plain Estradiol 2mg

tablets which is not

mentioned in CoPP

or FSC.

4. ANDROL tablets (Cyproterone Acetate 50mg)



Recommended by the

panel

Mee too, similar

product Androcur is


the name of M/s.

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

Minutes for 253rd


Bayer, Karachi. dated due to non

decision from so

many years. The

firm has pledged to

provide valid

documents before

the issuance of


5. GESTON INJ (Natural Progesterone

50mg/ml)


Group Co., Ltd, China Injectable facility

was separate and

under construction.

Not recommended

by the panel.

Panel has not

recommended the

product. May be

rejected.

6. GONACOR INJ 2000IU (Human Chorionic

Gonadotropin)

Yantai Beifang

Pharmaceutical Co.,

Ltd. China

Recommended by the

panel

Mee too, similar

product IVF-C is


the name of M/s.

Galaxy Karachi in

5000iu.

The firm has

proposed new brand

name as HCG-Excel

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated due to non

decision from so

many years. The

firm has pledged to

provide valid

documents before

the issuance of


7. GONACOR INJ (Human Chorionic

Gonadotropin 5000IU)

Yantai Beifang

Pharmaceutical Co.,

Ltd. China

Recommended by the

panel

Mee too, similar

product IVF-C is


the name of M/s.

Galaxy Karachi in

5000iu.

The firm has

proposed new brand

name as HCG-Excel

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated due to non

decision from so

many years. The

firm has pledged to

provide valid

documents before

the issuance of


Minutes for 253rd


8. HMG MASSONE (Human Menopausal

Gonadotropin 75IU)

Yantai Beifang

Pharmaceutical Co.,

Ltd. China

Recommended by

the panel. However

the panel has given

composition as FSH

75IU +LH 75IU

Mee too, similar

product IVF-M is


the name of M/s.

Galaxy Karachi in

75iu.

The product is

combination of75iu

of FSH and 75iu LH.

The firm has

proposed new brand

name Menopour

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated due to non

decision from so

many years. The

firm has pledged to

provide valid

documents before

the issuance of


9. HMG MASSONE (Human Menopausal

Gonadotropin 150IU)

Yantai Beifang

Pharmaceutical Co.,

Ltd. China

Recommended by

the panel. However

the panel has given

composition as FSH

150IU +LH 150IU

Mee too, similar

product IVF-M is


the name of M/s.

Galaxy Karachi in

150 iu.

The product is

combination of 150iu

of FSH and 150iu

LH.

The firm has

proposed new brand

name as

Menopour

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated due to non

decision from so

many years. The

firm has pledged to

provide valid

documents before

the issuance of


10. MENORIN 0.3mg (Conjugated Estrogen

0.3mg tablet)

Xinjiang Nuziline Bio-

pharmaceutical Co.,

Ltd. China

Recommended by the

panel.

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated.

Similar product

Premarin is already

registered in the

name of M/s. Pfizer

Karachi.

Minutes for 253rd


Decision in 250th Meeting: Registration Board deferred request of the firm for clarifications

of CoPP for co-pack products, details of already registered drugs in the name of company and

review of new molecules applied by the company.

The firm has provided following documents for Menorin tablets 0.3mg, Menocare and

Menstrol Tablets and . The case details as under;

S.

No.

Name and

Composition of the

Drug

Name of

Manufacturer

Panel Inspection

Report

Earlier

Evaluation

Latest

Documents

submitted

by the firm

1. MENORIN

0.3mg (Conjugated Estrogen 0.3mg

tablet)

Xinjiang Nuziline

Bio-pharmaceutical

Co., Ltd. China

Recommended

by the panel.

The firm has

submitted

application on

Form 5 A along

The firm

has

submitted

fresh CoPP,

11. ENDRALIN (Alarelin 150ug-Gnrh)


Pharmaceutical Co.,

Ltd Chian

Recommended by the

panel.

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated.

The product is new

molecule may be

treated as per

policy.

12. LUTRONE INJ 100UG (Gonadorelin 10‟s)


Pharmaceutical Co.,

Ltd China.

Recommended by the

panel.

The firm has

submitted

application on Form

5 A along with

required fee.

FSC, GMP and

CoPP provided,

however,

documents are out

dated.

The product is new

molecule may be

treated as per

policy.

Minutes for 253rd


Form 5A

Fee Rs.100000/-

Demanded price

Rs. 600/ pack

Pack size 14‟s

Mee too status

Premarin 0.3mg

Registered of

M/s. Pfizer,

Karachi.

with required

fee.

FSC, GMP and

CoPP provided,

however,

documents are

out dated.

Similar product

Premarin is

already

registered in

the name of

M/s. Pfizer

Karachi.

GMP and

FSC.

2. MENOCARE

tablets (Estradiol valerate

2mg and

Cyproterone acetate

1mg)



Recommended

by the panel

The firm has

submitted

application on

Form 5 A along

with required

fee.

FSC, GMP and

CoPP provided,

however,

documents are

out dated.

The product is

also combo

packed with

plain Estradiol

2mg tablets

which is not

mentioned in

CoPP or FSC.

Similar product

Climen is

already

registered in

the name of

M/s. Schering

AG, Karachi

having plain

Estradiol 2mg

tablets.

The firm

has

submitted

fresh CoPP,

GMP and

FSC and co

pack

justification.

3. MENSTROL

tablets (Levonorgestrel

0.5 mg

Estradiol 2mg)



Recommended

by the panel

The firm has

submitted

application on

Form 5 A along

with required

fee.

FSC, GMP and

CoPP provided,

The firm

has

submitted

fresh CoPP,

GMP and

Minutes for 253rd


however,

documents are

out dated.

The product is

also combo

packed with

plain Estradiol

2mg tablets

which is not

mentioned in

CoPP or FSC.

Similar product

is already

registered in

the name of

M/s. Schering

AG, Karachi

having plain

Estradiol 2mg

tablets.

FSC and co

pack

justification.

Case of above mentioned three (3) products is placed before the Board for a decision.

Decision: Registration Board deferred due to paucity of time.

Case No. c Local manufacturing of biological drugs of M/s. Macter Internatioanl

Karachi

Sr.

no.

Documents/ data as per

requirement of DRB 246

Documents / data submitted

by Macter

Remarks

1. Legalized GMP certificate of

biological drug as evidence that

manufacturer is an authorized

manufacturer of that particular

biological drug in its country of origin

Legalized GMP certificate no.

CN20110019 issued by State

Food and Drug administration

issued on 09/10/2011 and valid

up to 08/10/ 2016.

Legalized COPP no. 15009 for

finished drug 25 mg issued by

Shanghai Municipal Food and

Drug Administration. Issued on

29/01/2015 and valid up to

29/01/2017.

Original duly

Notarized and

Legalized

GMP

certificate no.

CN 20110019

ISSUED BY

State Food and

Drug

administration

indicating

etanercep

(Recombinant

Human Tumor

Necrosis

Factor-a

Receptor II-

Minutes for 253rd


IgG FC fusion

protein) issued

on 09/10/2011

and valid up to

08/10/2016.

Original duly

notarized and

legalized

COPP no.

15009 for

finished drug

25 etanercept

(Recombinant

Human Tumor

Necrosis

Facter-a

Receptor II-

IgG

2. Structural similarity of subject

biological drug product (ready to fill

bulk) with reference biological

product (innovator).

Structural similarity:

Primary structure/Identity.

Comparison of cDNA of

Momentum with Enbrel,

Comparison of amino acid

sequence by LCMS, N-

Terminal sequencing by Edman

degradation, C terminal

sequencing by LC-MS/MS,

UPLC peptide mapping.

Secondary structure by Circular

Dichorism, UV/visible

spectrophotometry. N-

Glycosylation analysis.

Identity by ELISA, Peptide

mapping.

Purity:

Purity comparison with

reference drug by

SEC- HPLC

SDS PAGE (Purity)

IEX analysis for charged

moieties

IEF analysis,

Western blotting

Safety testing of :

Host Cell DNA,

Host Cell protein,

Endotoxin levels.

Studies are

available in

provided DMF

by

manufacturer

Protein

sequence

compared with

WHO

sequence.

Minutes for 253rd


Biological activity:

Comparative biological activity

Momentum vs Enbrel by TNF

sensitive L929 cell cytotoxicity

neutralization assay.

3. Biocomparability studies including

identity testing to parent molecule,

purity testing, in vitro biological

activity / potency testing and toxicity

with support of IEF data, gel

electrophoresis, western blot and other

analytical methods and stability

studies of finished drug.

Comparative analysis of locally

produced drug product with

Reference medicinal product

(Enbrel- Wyeth).

Identity: Isoelectric focusing,

Purity: SDS PAGE

Potency: ELISA

General safety tests

Bacterial Endotoxin test,

Sterility test and abnormal

toxicity test.

Real time stability and

accelerated stability studies.

Stability

studies reports

of local

batches

provided.

4. Others Animal toxicity studies done

by CP Goijian, China:

Study 301-07

Acute (single dose) Toxicity of

rhTNFR: Fc for injection in Mice.

Study 301-08 Repeat dose toxicity

study of rhTNFR-Fc fusion

protein administered

to Rhesus by subcutaneous

injection.

Genotoxicity.

Carcinogenicity (including

supportive toxicokinetics

evaluations).

Reproductive and Developmental

Toxicity.

Study 301-09 Local toxicity study

of rhTNFR:Fc in rabbits.

Study 301-10 Hemolytic study of

recombinant human TNFR-

antibody fusion

Protein.

Animal

Toxicity

studies are part

of DMF

provided.

Bioequivalence

studies,

efficacy

clinical trials

and post

marketing

surveillance

studies done

by Shanghai

CP Goujian are

provided.

Minutes for 253rd


Bioequivalence and efficacy

Clinical trials data is

submitted:

Reports of

Biopharmaceutical Studies. Reports of Studies Pertinent to

Pharmacokinetics using Human

Biomaterials.

Reports of Human

Pharmacokinetic (PK) Studies.

Reports of clinical trials for

Efficacy and Safety Studies.

Reports of Post-Marketing

Experience.

Case Report Forms and Individual

Patient Listings.

Animal

Toxicity

studies are part

of DMF

provided.

Bioequivalence

studies,

efficacy

clinical trials

and post

marketing

surveillance

studies done

by Shanghai

CP Goujian are

provided.

Decision: The case was deferred for the requirement of section, manufacturing/ testing facilities

required for the particular product of the firm.

The firm has section approval for the manufacturing of recombinant human DNA protein

drugs. Etanercept is a recombinant human DNA protein drug. The firm has provided details

of manufacturing process and related equipments of each manufacturing step and detail of

trained persons. List of testing method required for quality testing and related QC

equipments and trained persons. Copy of last inspection report is provided verifying all the

equipment mentioned above. Firm has provided import documents of the procured

reference standard (WHO & EP), and reagents required for quality control of the product.

Manufacturing schedule on campaign basis of register products is also provided. The

manufacturing schedule shows that facility is having vacant capacity for 09 months

allowing ample time of clearance during product switch over facility also has disposable

flow path of drug which eliminates the risk of cross contamination facilities has validated

cleaning procedure.

Decision: Registration Board deferred the case due to paucity of time.

Minutes for 253rd


Case No. d Change in the concentration of Thiomersal from 0.01% to 0.005% for the

WHO PQ, registered products i.e. Tetanus Toxoid vaccine adsorbed – 0.5ml

Amp. (Reg. No. 059004), 5ml Vial (Reg. No. 053815) and 10ml Vial (Reg. No.

074631).

M/s. Hospital Services & Sales, Karachi has submitted an application on dated 13th

Aug‟ 2015

for the approval of “Change in the concentration of Thiomersal from 0.01% to 0.005% for a WHO PQ

following registered products” i.e.

1. Tetanus Toxoid Vaccine Adsorbed – 0.5ml Ampoule. (Reg. No. 059004),

1. Tetanus Toxoid Vaccine Adsorbed – 5ml Vial (Reg. No. 053815)

2. Tetanus Toxoid Vaccine Adsorbed – 10ml Vial (Reg. No. 074631)

The above products are manufactured by M/s. Serum Institute of India Ltd., India.

In letter, manufacturer has stated that “To support global drive of reducing exposure of Mercury,

they have reduced the concentration of Thiomersal in some of our vaccines including Tetanus

Toxoid Vaccine Adsorbed – 0.5ml Amp., 5ml Vial and 10ml Vial from existing 0.01% to

0.005%. The reduction of Thiomersal concentration does not have any impact on the product

efficacy and quality as they are using “Thiomersal” as a preservative to prevent microbial growth

in the final product.”

The above change in the registration has already been approved in the country of origin by the

concerned regulatory authority and reflecting at the WHO website also.

M/s. Hospital Services & Sales, Karachi has submitted the following documents along with the

request letter for approval:

1- DRAP fee as per relevant SRO.

2- Copy of registration letters and renewal status of the products.

3- Specification of existing and proposed concentration of Thiomersal.

4- Legalized Copy of approval for the proposed change in the concentration of Thiomersal

from the concerned regulatory authority in the country of origin (Pak Embassy attested).

5- Justification letter for the said changes / amendments on manufacturer‟s letter head duly

signed and stamped.

6- Legalized copy of CoPP reflecting the said changes (attested by Pak Embassy India).

7- Technical documents related to the said variation including stability data.

8- WHO approval in form of WHO website printouts for the said variation in the products.

Decision: Registration Board approved request of the firm for change Change in the

concentration of Thiomersal from 0.01% to 0.005% as per CoPP of the

country of origin and WHO Approval.

Minutes for 253rd


Case. No. e: shelf life extension Enbrel (Etaneracept) 50mg pre-Filled Syringe Injection

M/s Wyeth Pakistan Ltd has intimated that manufacturer abroad has extended

shelf life of their registered product from 24 month to 30 month based on the stability data on

long-term/recommended storage condition of 5oC +/- 3

oC and at the accelerated storage

condition of 25oC +/- 2

oC as detail below:-

Product Name Generic Dosage Form Strength Reg. No. Fee Deposit

Enbrel etanercept Injection 50mg 062228 Rs. 1000 &

4000/- on

12.3.2012 &

24.4.2013

2. Stability data presented supports 30 months expiry for Enbrel 50mg SFP Pre-Filled

Syringe at recommended storage of 2-8oC. Detailed Stability data have been is available for

perusal of the board.

Decision: Registration Board approved the extension of shelf life as per CoPP of the

country of origin.

Case. No. f. Change of Manufacturer Name

M/s ICI Pakistan has informed that the manufacture name the following registered

Animal Health Vaccines has been changed without change of manufacturing site and location.

Existing name of manufacturer:

Schering Plough Animal Health USA.

New name of manufacturer:

Intervet Inc., USA (doing business as Merck /MSD Animal Health)

S. No. REG NO. NAME OF PRODUCTS

1 039919 NEWCASTLE N-79

2 039920 NEWCASTLE N-63

3 039924 LT-IVAX

4 039925 ENTER5OVAX

5 039984 COCCIVAC-D

Minutes for 253rd


6 041296 COCCIVAC-B

7 057112 F VAX MG

8 028572 BURSA-VAC

9 028573 UNIVAX-BD

2. The firm has submitted following:

i. Fee of Rs 50,000/- per product.

ii. Copies of initial registration letters.

iii. Original legalized GMP/FSC of the products and statement letter

iv. Renewal status of products/copies of form 5B of the above 09 products

Decision: Regiatrtion Board approved request of firm for change in manufacturing site as per

above details.

Case. No. g. Case of M/s. Graton Pharma, Karachi for the registration of

Interferon Alfa 2b 3000iu /Vial (Lipheron From Beijing Shanglu, China)

The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration

of Interferon Alfa 2b 300MIU injections 22.6. 2011 but their application has not been considered

in any meeting till date .The firm has provided evidence of documents and fee challans submitted

by them.

The case of the firm belongs to pre devolution at the time to Drugs Control Organization,

Ministry of Health. The section tried to retrieve the application from old record but still the

record is not found. Copy of GMP shows its validity till 14.03.2015. Copy of CoPP has also been

provided by the company. Registration Board in 252nd

meeting decided as follows:

“The Board deferred the case for completion of documents by the firm and to

present the case with all available details in the next meeting of Registration Board.”

M/s Graton Pharma, Karachi as has requested in the previous meeting for the import of

their interferon. The case was considered and deferred for provision of original documents. The

firm has submitted photocopies of their documents. In the instant shifting of record of biological

division and touring abroad of DDC (BIO) their file are not traceable instantly.

The firm has also submitted documents regarding registration of steroil water for

injection for their products. They have provided on form-5 CD version of registration dossiers,

Minutes for 253rd


certificate of pharmaceutical product (Photocopy). However the firm has not submitted

additional fee required for water for injection and that promised to submitted at the earliest

before issuance of any letter regarding inspection abroad are registration letter.

The Board may consider their case on merit, whereas biological division is retrieving

their documents and shall present before the Board as soon as they are available. Meanwhile the

process of foreign inspection as per import policy may be considered and the firm may be

directed to give undertaking on judicial stamp paper that outcome of the inspection what so ever

will not confer the right of consideration if the firm could not qualify for the GMP certification.

The firm shall be exempted from inspection, if their inspection has waiver as per import policy.

Decision: Registration Board deferred the case for completion of documents by the

firm and to present the case with all available details in the next meeting of Registration

Board.

Minutes for 253rd


B. Medical Devices.

Case No.07. Applications for Registration of Medical Devices for Import.

Registration Board considered the following applications of medical devices for

import and decided as mentioned against each. Approved applications have already been

recommended by Expert Committee on Medical Devices and are subject to inspection of

manufacturer abroad, verification of storage facilities etc as per policy:-

a) CATHETERS:

S.No Name of Importer and

Manufacture/Exporter.

Name of Medical

Device

Price & Pack

size

Shelf

life

Decision

1. M/s Johnson & Johnson Pakistan

(Pvt) Limited, Fl.19, Sub Plot

F-1, Kehkashan Scheme No.5,

Main Boat Basin, Clifton,

Karachi.

Legal Manufacturer: M/s Cordis Cashel, Cahir Road,

Cashel, Co. Tipperary, Ireland.

Physical Manufacturer: M/s Cordis de Mexico,

S.A. de C.V. Circuito Interior

Norte # 1820 Parque Industrial

Salvarcar Ciudad Juarez,

Chihuahua CP 32574 Mexico.

MaxiLD

PTA Dilatation

Catheter

(Product codes and

sizes as per Free

Sale Certificate)

Decontrolled

till policy

decision by the

Federal

Government

1‟s

18

month Approved.





Karachi.

Legal Manufacturer: M/s Cordis Corporation, 14201

North West 60th Avenue, Miami

Lakes, Florida 33014, USA.

Assembler: M/s Cordis de Mexico,

S.A. de C.V. Circuito Interior

Norte # 1820 Parque Industrial

Salvarcar Ciudad Juarez,

Chihuahua CP 32574 Mexico.

Powerflex Pro

PTA Dilatation

Catheter

(Product codes and

sizes as per Free

Sale Certificate)

Decontrolled

till policy

decision by

Policy Board/

Federal

Government

1‟s

3 years Approved.

Minutes for 253rd


b) STENTS:



Name of Medical

Device

Price &

Pack size

Shelf

life

Decision





Karachi.

Legal Manufacturer: M/s Cordis Cashel Cahir Road

Cashel, Co. Tipperary, Ireland

Manufactured by: M/s Burpee Material Technology

LLC, 15 Christopher way,

Eatontown, New Jersey, 07724,

USA.

S.M.A.R.T Flex

Vascular Stent

System

(Sizes and product

codes as per Free

Sale Certificate)

Decontrolled

till policy

decision by

Policy Board/

Federal

Government

1‟s

2

years Approved.

2. M/s Intek Corporation,

# 30,1st Floor, Al-Amin Plaza,

The Mall, Rawalpindi.

Legal Manufacturer

M/s Terumo Europe N.V.,

Interleuvenlaan 40, 3001 Leuven,

Belgium.

Manufacturing Site Ashitaka Factory of Terumo

Corporation,

150, Maimaigi-cho, Fujinomiya

City, Shizuoka Prefecture 418-

0015, Japan.

Nobori Drug

Eluting Stent

System

(Biolimus A-9

Eluting Stent)

Expanded Stent

nominal Length

(mm): 8, 14, 18,

24, 28.

Expanded Stent

Nominal Inner Dia

(mm): 2.25, 2.50,

2.75, 3.0, 3.50, 4.0.

(Different product

codes as per FSC)

Decontrolled

till policy

decision by

Policy Board/

Federal

Government

1‟s

18

months Approved.

3. M/s Intek Corporation,

No.30, 1st Floor, Al-Amin Plaza,

The Mall, Rawalpindi/

Legal Manufacturer

M/s Terumo Europe N.V.,

Interleuvenlaan 40, 3001 Leuven,

Belgium.

Manufacturing Site Ashitaka Factory of Terumo

Corporation,

150, Maimaigi-cho, Fujinomiya

City, Shizuoka Prefecture 418-

0015, Japan.

Design Site Terumo Corporation, R&D

Ultimaster

Sirolimus Eluting

Coronary Stent

System

Non expanded

nominal Stent

Length (mm): 9,

12, 15,18, 24, 28,

33, 38.

Nominal expanded

Stent Inner Dia

(mm): 2.25, 2.50,

2.75, 3.0, 3.50, 4.0.

Decontrolled

till policy

decision by

Policy Board/

Federal

Government

1‟s

2 years Approved.

Minutes for 253rd


Centre, 1500, Inokuchi, Nakai-

Machi, Ashigarakami-gun,

kanagawa, Perfecture, Japan.

(Different product

codes as per FSC)

4. M/s Otsuka Pakistan Ltd,

30-B, S.H.C.H.S, Karachi/

Manufacturer: M/s Shanghai MicroPort

Medical (Group) Co. Ltd, 501

Newton Road, ZJ Hi-Tech Park,

Pudong New Area, Shanghai,

China.

Production and packaging site:

501 Newton Road, ZJ Hi-Tech

Park, Pudong New Area,

Shanghai, China.

Tube Extrusion Site: 1601-Zhangdong Rd, ZJ Hi-Tech

Park, Pudong New Area,

Shanghai, China.

Sterilization Site: Building #.4, 51 Hangfan Rd,

Hangtou Town, Pudong New

Area, Shanghai, China.

Firehawk

Rapamycin Target

Eluting Coronary

Stent System

Stent Length (mm):

13, 16, 18, 21, 23,

26, 29, 31, 33, 35,

38.

Stent Dia (mm):

2.25, 2.50, 2.75,

3.0, 3.5, 4.0.

Different product

codes as per Free

Sale Certificate.

Decontrolled

till policy

decision by

Policy Board/

Federal

Government

1‟s

12

months Approved.

5 M/s Cardiovascular Medical

System, 202, 2nd

Floor, Eden

Heights, Jail Road, Lahore.

Owner/Legal Manufacturer: M/s amg International GmbH

Lohnfeld 26, D-21423 Winsen-

Luhe, Germany.

Manufactured by:

M/s QualiMed Innovative

Medizinprodukte GmbH,

BoschstraBe 16, 21423, Winsen-

Luhe, Germany.

ITRIX Rapamycin

Eluting Coronary

Stent Implantation

System

Stent Length (mm):

10, 14, 18, 24, 28,

34, 38.

Balloon Dia (mm):

2.00, 2.25, 2.50,

2.75, 3.00, 3.25,

3.50, 4.00.

Different product

codes as per Free

Sale Certificate.

Decontrolled

till policy

decision by

Policy Board/

Federal

Government

1‟s

12

months Approved.

6 M/s Cardiovascular Medical

System, 202, 2nd

Floor, Eden

Heights, Jail Road, Lahore.

Owner/Legal Manufacturer: M/s amg International GmbH

Lohnfeld 26, D-21423 Winsen-

Luhe, Germany.

Manufactured by:

ARTHOS Pico

Stent

Implantation

System

Stent Length (mm):

8, 10, 12, 14, 16,

18, 19, 24, 28, 34,

38.

Balloon Dia (mm):

Decontrolled

till policy

decision by

Policy Board/

Federal

Government

1‟s

12

months Approved.

Minutes for 253rd


M/s QualiMed Innovative

Medizinprodukte GmbH,

BoschstraBe 16, 21423, Winsen-

Luhe, Germany.

2.00, 2. 25, 2.50,

2.75, 3.00, 3.25,

3.50, 4.00.

Different product

codes as per Free

Sale Certificate.

c) INFUSION SETS:



Name of Medical

Device

Price & Pack

size

Shelf

life

Decision

1. M/s IBL HealthCare Limited,

9th Floor, N.I.C. Abbasi Shaheed,

Karachi./

Manufactured by: M/s Ultra for Medical Products

Co. (ULTRAMED), Industrial

Area, Arab El-Awamer, Abnoub,

Assiut-Egypt.

Kari Fusion I.V

Infusion Set.

Decontrolled

till policy

decision by the

Policy Board/

Federal Govt.

1‟s

5 Years Approved.

d) BLOOD TRANSFUSION SETS:



Name of Medical

Device

Price & Pack

size

Shelf

life

Decision

1. M/s IBL HealthCare Limited,

9th Floor, N.I.C. Abbasi Shaheed,

Karachi./

Manufactured by: M/s Ultra for Medical Products

Co. (ULTRAMED), Industrial

Area, Arab El-Awamer,

Abnoub, Assiut-Egypt.

Kari Flex Blood

Administration Set

Decontrolled

till policy

decision by the

Policy

Board/Federal

Government

1‟s

5

years Approved.

e) SYRINGES:



Name of Medical

Device

Price & Pack

size

Shelf

life

Decision

1. M/s Hashir Surgical Services

(Pvt) Ltd,

1st Floor, House No.16, Street 1,

Sector F-2, Phase-6, Hayatabad,

Peshawar

ABC Conventional

Syringe

Decontrolled

till policy

decision by the

Policy Board/

Federal

5 years Rejected due to

poor physical

parameters like the

piston of the

syringe is not

Minutes for 253rd


Manufactured By: M/s Revital Healthcare (EPZ)

Ltd, Plot No. MN/V/225 & 226,

Post Box -80713-80100,

Mombasa, Kenya.

Government

(1ml, 2ml, 3ml,

5ml, 10ml,

20ml)

operating smoothly

inside the barrel.

The marking on the

barrel of the

syringe is not

permanent and is

with delible ink.

2. M/s Universal Enterprises,

29-Block-3 Overseas Co-

operative Housing Society

Stadium Road, Karachi

Manufactured by:

Terumo Corporation,

44-1, 2-Chome, Hatagaya,

Shibuya-ku, Tokyo, Japan.

Manufacturing Site:

Kofu Factory of Temumo

Corporation, 1727-1, Tsuijiarai,

Showa-cho, Nakakoma-gun,

Yamanashi Perfecture, Japan.

Terumo Syringe Decontrolled

till policy

decision by the

Policy Board/

Federal

Government

(50 ml)

5 years Approved.

Case No.08. Withdrawal of Registration Applications of Medical Devices.

M/s. Trans Angio System, Karachi-75400 is withdrawing their registration applications of

following medical devices as mentioned against each. :-



Name of Medical

Device (s)

Demanded

price & Pack

size

Shelf

life

Remarks

1. M/s. Trans Angio System,

Karachi-75400

Manufactured by

M/s. Translumina GmbH,

Neue Rottenburger

Hecingen, Germany.

Yukon Choice 4DES+

Coronary

Stent System

Decontrolled. 03

years

Firm has informed that

they are withdrawing

their application

submitted on 5th April,

2011 for the registration

of Yukon Choice +4 DES

Coronary Stent System.

The application is being

withdrawn due to

obsolete design and

technology which is

being replaced with the

newer one.

2. M/s. Trans Angio System,

Karachi-75400

Manufactured by

M/s. Translumina GmbH,

Neue Rottenburger

Hecingen, Germany.

Yukon Choice 4

Coronary Stent

System

Decontrolled. 03

years

Firm has informed that

they are withdrawing

their application

submitted on 5th April,

2011 for the registration

of Yukon Choice 4

Coronary Stent System.

Minutes for 253rd


The application is being

withdrawn due to

obsolete design and

technology which is

being replaced with the

newer one.

Decision: Registration Board considered the request of the firm for withdrawal of its

applications for registration of above mentioned medical devices and approved

the request.

Case No.09. Misclellaneous cases.

a) Change of Importer’s Address.

M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has informed that in continuation to

their ongoing Business Model change in Pakistan it is brought into your kind notice that M/s

Johnson & Johnson Pakistan (Pvt) Ltd, Karachi local office address have been changed.

Following is the change in office address:-

Previous Address New address

M/s Johnson & Johnson Pakistan (Pvt)

Ltd, Plot No.10 & 25, Sector 20 Korangi

Industrial Area, Karachi-74900.

M/s Johnson & Johnson Pakistan (Pvt)

Ltd, Fl-19, Sub-Plot F-1, Kehkashan

Scheme No.5 Main Boat Basin, Clifton,

Karachi-75600.

The firm has submitted the following documents:-

(i) Fee challan of Rs.5000/-.

(ii) Drug Sale License of new address.

Decision: Registration Board approved the new address of M/s Johnson & Johnson

Pakistan (Pvt) Ltd i.e. Fl-19, Sub-Plot F-1, Kehkashan Scheme No.5

Main Boat Basin, Clifton, Karachi-75600 subject to verification of local

storage facility.

b) Change of Extension names of already registered medical devices for import.

M/s Atco Pharma International (Private) Limited, Karachi have requested for approval of

change of extension names of their already registered medical devices for import:-

S.No. Reg. No. Existing/Approved brand

Names with extension

names

Requested Extension

Names.

Minutes for 253rd


1. 074718 Alvision TM

Cardiovascular

Angiographic Catheter.

Alvision TM

Interventional

Cardiology Diagnostic

Catheter.

2. 074719 Invader TM

CTO Coronary

Angioplasty Balloon

Catheter.

Invader TM

CTO Balloon

Dilatation Catheter.

3. 074720 Invader TM

PTCA Coronary

Angioplasty Balloon

Catheter.

Invader TM

PTCA Balloon

Dilatation Catheter.

4. 074721 Turquoise TM

PTCA

Coronary Angioplasty

Balloon Dilatation Catheter.

Turquoise TM

PTCA

Balloon Dilatation Catheter

5. 074722 Commander TM

Coronary

Stent Delivery System.

Commander TM

CoCr Bare

Metal Stent

6. 074723 Ephesos-II Coronary Stent

Delivery System.

Ephesos TM

II Bare Metal

Stent

7. 074725 Constant TM

Coronary Stent

Delivery System.

Constant TM

Bare Metal

Stent

The firm has stated that due to marketing strategy, their principal manufacturer M/s Alvi

Medica Tibbi Urunler San. Ve Dis. Tic, A.S. Istanbul, Turkey has changed extension names of

the above mentioned products. The principal manufacturer has clarified that product

specification, raw material, production process and brand names will remain unchanged.

Furthermore, M/s Alvi Medica has also informed that due to same marketing strategy, their all

cardiovascular products are manufactured with new design of product boxes and labels.

The firm has submitted the following supporting documents:-

(i) Fee Challan of Rs. 50,000/- for each product.

(ii) Form 5-A for each product.

(iii) Copies of Registration Certificates of medical devices.

(iv) Original Free Sale Certificate from Regulatory Body of country of origin with

new extension names (Embassy attested).

(v) CE certificate mentioning new extension names.

(vi) Copy of Design Examination certificate mentioning new extension names.

(vii) Justification letter issued by principal manufacturer for change of extension

names and new design of product boxes and labels.

(viii) Copy of Drug Sale License.

(ix) Copy of CRF clearance letter.

(x) Undertakings (i) that there is no other change in the product except extensions (ii)

that proposed label of products complies all provisions of Drugs (Labeling and

Packing) Rules, 1986 (iii) that proposed names do not resemble with already

Minutes for 253rd


registered brand. In case of resemblance/similarity of brand name and packaging

of applied product with any other registered brand, they would be liable to change

the brand name and packaging of their product (iv) that dosage, administration,

indication and direction for use etc on the label is in line with that of

registration/marketing authorization and (v) That we have never imported our

registered medical devices with new brand names.

(xi) Old and new Artwork and difference between them.

Decision: Registration Board discussed the case and approved the new design of product

boxes and labels and above mentioned new extension names of already

registered medical devices for import of M/s Atco Pharma International (Private)

Limited, Karachi. All other terms and conditions of registration shall remain the

same.

c) Inspection of Manufacturer Abroad M/s Sumbow Medical Instruments Co.

Ltd, China.

Registration Board in its 242nd

meeting held on 24th

& 25th

February, 2014 considered and

approved the following medical devices of M/s BNS Trading Est, Lahore subject to inspection of

manufacturer abroad, verification of storage facilities etc as per policy:-

S.# Name of Importer and

Manufacturer/Exporter

Name of Medical Device Pack size Shelf

Life

(i) M/s BNS Trading Est,

244-Allama Iqbal Road,

Mustafabad, Lahore.

Manufactured by M/s Sumbow Medical Instruments

Co. Ltd, 16F Chengtou Building,

No.68 Heji Street, Jiangdong

District, China.

Safe 1 Brand IV Cannula

(Pen Type)

(14G, 16G, 18G, 20G,

22G, 24G)

1‟s 3 years

(ii) -do- 3S Safe Infusion Set 1‟s 3 years

Dr. Sheikh Akhtar Hussain, Deputy Director General, DRAP, Lahore and Mr. Khalid

Mahmood, the then DDC (QC), DRAP, Islamabad were nominated for inspection of aforesaid

manufacturer. The panel conducted inspection on 25th

& 26th

May, 2015 and submitted the

report.

The applicant firm submitted the documents in registration application dossier including

Form 5-A, ISO 13485 certificate, EC certificate (Production Quality Assurance), Credential of

manufacturer abroad, Free Sale Certificate issued by SFDA, China and letter of authorization

claiming M/s Sumbow Medical Instruments Co., Ltd, 16F Chengtou Building, No.68 Heji

Minutes for 253rd


Street, Jiangdong District, China as the manufacturer of the applied products. The inspection

letter was also issued with aforesaid manufacturer‟s name and address but in the inspection

report manufacturer name was not clear and site address was also different. The name and

address of manufacturer in the inspection report was mentioned as M/s Sumbow Medical

Instruments Co. Ltd, Jiangsu Webest Medical Product Co. Ltd, No.5, Yingchun Road,

Industrial Park, Xuyi, Jiangsu, China. In the inspection report the address “16F Chengtou

Building, No.68 Heji Street, Jiangdong” is shown as postal address. Furthermore, all the

documents attached with the inspection report including copy of Free Sale Certificate, copies of

bill of lading, stability study data and other documents written in Chinese language have been

stamped by M/s Jiangsu Webest Medical Product Co. Ltd. The panel recommended the above

products for registration.

In this regard both panel members were requested to clarify regarding status of

manufacturer. Both the members of panel have submitted as under:-

Mr. Khalid Mahmood, FID-II, DRAP, Islamabad. “You have desired to clarify that in the inspection report manufacturers name is not

clear and site address is also different for M/s Sumbow Medical Instruments Co.,

Limited, China. I have already clarified that there are number of firms working in the

China in the name and style of Sumbow Medical Instruments, China and the one we

have visited for inspection was Sumbow Medical Instruments. It was further clarified

that the Division of Medical Devices and Medicated Cosmetics need to go by the book.

The firm which we have inspected submitted the report accordingly (The report is

submitted by Dr. Sheikh Akhter Hussain from Lahore). Further it is necessary to

clarify that the credentials already submitted by M/s Sumbow Medical Instruments

Company Limited, China through its importer M/s B.N.S Trading Est, Lahore needs to

be matched and if some anomalies are found then the case may be decided as per

prevailing law/SOPs etc. It is further clarified that the report is submitted in accordance

with the tour arranged by the importers of Pakistan from China and the panel is not

conversant with the geographical limits of provinces in China. The panel submitted the

reports in accordance with the facilities visited and provided with the names of their

sites/cities/provinces in China and no facts have been concealed in writing the reports

that is why you may be experiencing in variation of documents/information submitted

by M/s B.N.S. Trading Est, Lahore. It is therefore again requested that the report is

submitted in accordance with the Manufacturer got visited by the importer to us. The

copies of pictures of the plant addresses, disposable packs are attached for your further

necessary action as per law. Any further clarification may be solicited if desired so and

the firm M/s B.N.S.Trading Est, Lahore may also be intimated as may be the exporter

name is M/s Sumbow Medical Instruments Limited, China.”

Minutes for 253rd


Dr. Sheikh Akhter Hussain, DDG, DRAP, Lahore. “It is to inform you that name and address of the manufacturer has been misinterpreted

by considering two different names as one, as “M/s Sumbow Medical Instrument Co.,

Limited, Jiangsu Webest Medical Product Co., Ltd, No.5, Yingchum Road, Industrial

Park, Xuyi, Jiangsu, China”. The factual position with regard to name and addresses of

these two concerns is clarified that M/s Jingsu Webest Medical Product Co., Ltd., No.5,

Yingchum Road, Industrial Park, Xuyi, Jiangsu, China is the manufacturer and M/s

Sumbow Medical Instruments Co., Ltd., is a sister concern, hence referred to

documents, attached with the inspection report, have been stamped by the

manufacturer. A copy of the certificate, dated 11-03-2014, signed by the manufacturer

as well as sister concern thereof, which is self-explanatory with respect to status of both

the said concerns, is attached herewith for further clarification in this regard. It would

not be out of place to mention here that the inspection report submitted by the

nominated panel is based on facts observed by it during the inspection/visit.”

Furthermore, the certificate by the manufacturer and exporter attached with the

clarification, is reproduced as under:-

“It is certified that M/s Sumbow Medical Instruments Co., Add:16F, Chengtou

Building, No.68 Heji Street, Jiangdong District, Ningbo 315041 China is a sister

concern of M/s Jiangsu Webest Medical Products Co., Ltd, Yingchun Rd, Industrial

Park, Xuyi, Jiangsu, China. All the goods supplied, distributed and exported are

manufactured by M/s Jiangsu Webest Medical Products Co., Ltd, Yingchun Rd,

Industrial Park, Xuyi, Jiangsu, China. Registered office of M/s Sumbow Medical

Instruments Co is 16F, Chengtou Building No.68 Heji Street, Jiangdong District,

Ningbo 315041 China and manufacturing site with the name of M/s Jiangsu Webest

Medical Products Co., Ltd located at Yingchun Rd, Industrial Park, Xuyi, Jiangsu,

China. The products manufactured by M/s Jiangsu Webest Medical Products Co., Ltd,

located at Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China are exported to Pakistan

through the sole rights of M/s Sumbow Medical Instruments Co., is 16F, Chengtou

Building No.68 Heji Street, Jiangdong District, Ningbo 315041 China.”

Decision: Deferred for discussion in the next meeting of Registration Board.

d) Grant of Additional Size of registered imported medical devices.

M/s Mana & Co, Karachi has requested to grant additional size of their following

registered imported medical devices as mentioned below:-

S.No Regn.

No

Name of Product Existing

Approved

Sizes

Demanded

Additional

Sizes.

Name of

Manufacturer

1. 074703 Medicare Sterile

Syringe for Single Use.

1ml

2ml

5ml

10ml

20ml

3ml Changzhou Jiafeng

Medical Equipment

Co. Ltd, Jiangsu

Province, China.

Minutes for 253rd


2. 074812 Medicare + Disposable

Syringe

1ml

2ml

5ml

10ml

20ml

3ml M/s Jiangyin Medical

Devices Co. Ltd,

Jiangsu, China

The firm has submitted following documents:-

(i) Fee challan of Rs.5000/- for each product.

(ii) Copies of registration letter of each product.

(iii) Copy of Drug Sale License.

(iv) Original Free Sale Certificates by SFDA China (Embassy attested) mentioning 3

ml size of syringes.

Decision: Registration Board approved additional size of 3ml Medicare Sterile Syringe

for Single Use (Reg. No. 074703) and additional size of 3ml Medicare + Disposable Syringe

(Reg. No. 074812). All other terms and conditions of registration shall remain the same.

Registration Board deferred remaining agenda due to paucity of time.

Meeting ended with a vote of thanks to and from the chair.

End of Document

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