Upload
dotram
View
217
Download
0
Embed Size (px)
Citation preview
Application Number
Date of submission of the
dossier
Name of the 1st
Evaluator Signature
Name of the 2nd
Evaluator Signature
Date of 1st evaluation
Date of 2nd Evaluation
Number of files
received
CONCLUSION OF THE ASSESSMENT
RECOMMENDED (no outstanding issues)
QUERY RAISED (Indicate the sections where query is
raised)
REJECTED (indicate the module(s) that led to the
rejection)
(Please delete which does not apply)
TYPE OF APPLICATION – HUMAN, BIOLOGICAL OR VETERINARY PRODUCT
(Please delete / change which does not apply)
MODULE 1: ADMINISTRATIVE INFORMATION
SECTION 1: PARTICULARS OF THE PRODUCT
1.1 Name and address of Applicant
(Company) Name: NEM LABORATORIES PVT. LTD:
Address: 133, Krishna Ind. Estate, Navghar Rd.,Vasai (E), Dist. Thane- 401210
Country : INDIA
Telephone: 0250-239002/3
Telefax: 0250-2392905
E-Mail: [email protected]
For PPB use only
1.2 Trade Name of the product (Proprietary Product Name): AZYCIN-500 Tablets
For PPB use only
1.3 International Non-proprietary Name (INN) of the Active Pharmaceutical Ingredient (API) : Azithromycin
dihydrate BP
For PPB use only
1.4 Strength of Active Pharmaceutical Ingredient (API) per unit dosage of the product:
Azithromycin dihydrate
Eq. to Azithromycin BP…500 mg
For PPB use only
1.5 Pharmaceutical Dosage form and route of administration of the product
1.5.1 Pharmaceutical Dosage form of the product: Tablet
1.5.2 Route(s) of administration (use current list of standard terms - European Pharmacopoeia): Solid Oral
Dosage form For PPB use only
1.6 Packing/pack size of the product: 1x3Tablets
For PPB use only
1.7 Visual description of the product: Orange colour, oval shape film coated tablets with both sides
plain.
For PPB use only
1.8 Proposed shelf life (in months): 36 months
1.8.1 Proposed shelf life (after reconstitution or dilution): Not Applicable
1.8.2 Proposed shelf life (after first opening container): Not Applicable
1.8.3 Proposed storage conditions: Store in a cool dry place away from the reach of children.
1.8.4 Proposed storage conditions after first opening: Not Applicable For PPB use only
1.9 Pharmacotherapeutic group and ATC Code
1.9.1 Pharmacotherapeutic group: Antibacterials for systemic use, macrolides
1.9.2 ATC Code: J01FA10 (Please use current ATC code)
1.9.3 If no ATC code has been assigned, please indicate if an application for ATC code has been made: For PPB use only
1.10 Legal category
1.10.1 Proposed dispensing category/classification: Product is subject to medical prescription or not subject to medical
prescription (Please delete which does not
apply)
1.10.2 For products subject to medical prescription: Controlled Drug Substance or Prescription Only Medicine, POM
(Please delete which does not apply)
1.10.3 For products not subject to medical prescription: The product will be dispensed from Non-pharmacy outlets and
pharmacies ( if applicable ) or Pharmacies only (Please delete which does not apply) For PPB use only
1.11 Country of origin or country of release: INDIA
For PPB use only
1.12 Product Marketing Authorisation in the country of origin and other countries. (Attach certificate of
pharmaceutical product from competent regulatory authority) If not registered, state reasons : Refer
Module 1, Section 1.12
Authorised
Country:INDIA
Date of authorisation (dd-mm-yyyy):
11thMay2000
Proprietary name: AZYCIN-500
Authorisation number:793
Refused
Country:
Date of refusal (dd-mm-yyyy):
Reason for Refusal:
Withdrawn (by applicant after authorisation)
Country:
Date of withdrawal (dd-mm-yyyy):
Proprietary name:
Reason for withdrawal:
Suspended/revoked (by competent authority)
Country:
date of suspension/revocation (dd-mm-yyyy):
Reason for suspension/revocation:
Proprietary name: For PPB use only
1.13 Pre-registration analysis of the product
(Attach certificate of analysis from a recognized WHO Prequalified Quality Control Laboratory in Kenya and
within the Region )
For PPB use only
1.14 Name(s) and complete address(es) of the manufacturer(s)
1.14.1 Name(s) and complete address(es) of the manufacturer(s) of the finished pharmaceutical product (FPP),
including the final product release if different from the manufacturer. (Add as many rows as necessary)
Name: Mr. Dhaval Talati
Company name : NEM LABORATORIES PVT. LTD:
Address: 133, Krishna Ind. Estate, Navghar Rd.,Vasai (E), Dist. Thane- 401210
Country :INDIA
Telephone: 0250-239002/3
Telefax: 0250-2392905
E-Mail: [email protected]
If the manufacturer is different to 1.1 above, explain the relationship: Not Applicable
1.14.2 Name(s) and complete address(es) of the manufacturer(s) of the active pharmaceutical ingredient(s) (API)
(Add as many rows as necessary)
Name: Azithromycin BP
Company name: MEHTA PHARMACEUTICAL INDUSTRIES
Address: Unit No. III, Kopri Village Naka, Veer Savarkar Marg, Chandansar, Virar (East),401 305 Dist. Thane,
(M.S.)
Country: INDIA.
Telephone: 2673 0751/ 6692 6545
Telefax: (022) 2673 3485
E-Mail:---- For PPB use only
1.15 Good Manufacturing Practice (GMP) status of the manufacturer (s) of the FPP :
Refer Module 1, Section 1.12
For PPB use only
1.16 Name and complete address of the Local Technical Representative of Manufacturer
Name :
Company Name: PHARMAX AFRICA LTD
Address: 1ST FLOOR, METRO TOWERS OGINGA ,ODINGA STREET, P.O. BOX: 5471-30100 ,ELDORET.
Country : KENYA
Telephone: 0532030142
Telefax: -----
E-Mail: [email protected] /www.pharmaxafrica.com
If the Local Technical Representative is different to 1.1 above, explain and provide evidence for the relationship: For PPB use only
1.17 Summary Product Characteristics (SPC) : Refer Module 1, Section 1.17
For PPB use only
1.18 Batch number(s) of the FPPs used in (Add as many rows as necessary)
Clinical/bioequivalence studies Not Applicable
Stability studies AZI-1 AZI -2 AZI -3
Validation/production scale batches AOD-1 AOD-2 AOD-3
Comments [e.g., batch size, explanation of NA (not applicable) answers] ---
Composition of clinical, primary stability and validation/production FPP batches (kg)
Ingredients
Administration
Unit
Bioequivalence
˂batch number˃
Primary stability
batch number: AZI-1
Production
batch number: AOD-1
Mg %* Kg %* Kg %* kg %*
Core tablet / capsule contents / injections / suspensions, etc.
Active
Azithromycin Dihydrate B.P.
eq. to Azithromycin base B.P. 550.0 76.017 -- -- 68.75 76.017 68.75 76.017
Excipient
Maize Starch BP 56.781 7.847 -- -- 7.097 7.847 7.09 7.847
Lactose BP 30.00 4.146 -- -- 3.75 4.146 3.75 4.146
Microcrystalline Cellulose BP 10.00 1.382 -- -- 1.25 1.382 1.25 1.382
Polyvinyl pyrollidone K-30 BP 14.00 1.934 -- -- 1.75 1.934 1.75 1.934
Colloidal anhydrous silica BP 1.00 0.138 -- -- 0.125 0.138 0.125 0.138
Magnesium Stearate BP 8.00 1.105 -- -- 1.00 1.105 1.00 1.105
Cross povidone BP 20.00 2.764 -- -- 2.5 2.764 2.5 2.764
Talcum BP 10.0 1.382 1.25 1.382 1.25 1.382
Purified water BP 0.124
ml -- 15.5 lit. -- 15.5 lit. --
Subtotal 1 699.90 -- -- -- 87.49 -- 87.49 --
Film coat / capsule shell / printing ink
Proprietary Film-coating
mixture**
Titanium Dioxide BP 2.94 0.406 -- -- 0.3675 0.406 0.3675 0.406
Polyethylene glycol 400 USP 4.90 0.677 0.6125 0.677 0.6125 0.677
Isopropyl Alcohol BP 0.1178 0.016 -- -- 0.0147 0.016 0.0147 0.016
Hydroxypropyl methylcellulose
BP
12.376
1.710
1.547
1.710
1.547
1.710
Propylene Glycol BP 2.94 0.406 0.3675 0.406 0.3675 0.406
Colour Sunset yellow IHS 0.0495 0.006 -- -- 0.0061 0.006 0.0061 0.006
Methylene Chloride 0.2970 0.041 0.0371 0.041 0.0371 0.041
Subtotal 2 23.62 -- -- -- 2.95 -- 2.95 --
Grand total 723.52 --- -- -- 90.44 --- 90.44 ---
NOTE : Water and Solvents evaporate during process
Equivalence of the composition or justified
differences
Composition is same for Stability study, Process validation study
and Commercial batch .
* Each ingredient is expressed as a percentage of the grand total.
** All components of the proprietary mixture are described in the compendia
For PPB use only
OVERALL QUERIES AND RECOMMENDATIONS FOR THIS MODULE
MODULE 2: CHEMICAL, PHARMACEUTICAL, NON-CLINICAL AND
CLINICAL OVERVIEWS AND SUMMARIES -
2.1 OVERALL TABLE OF CONTENTS OF MODULES 2, 3, 4, AND 5
2.2 INTRODUCTION
2.2.1 Proprietary name:
AZYCIN-500
2.2.2 Non-Proprietary name or Common name of drug substance:
Azithromycin Tablets 500mg
2.2.3 Company Name:
M/s. NEM LABORATORIES PRIVATE LTD.
2.2.4 Dosage form (s) of the product
Tablet
2.2.5 Strength(s) of the product:
500 mg
2.2.6 Route of Administration:
Oral
2.2.7 Proposed Indication (s):
It is indicated Azithromycin is indicated for the following bacterial infections induced by
micro-organisms susceptible to azithromycin
- Acute bacterial sinusitis (adequately diagnosed)
- Acute bacterial otitis media (adequately diagnosed)
- Pharyngitis, tonsillitis
- Acute exacerbation of chronic bronchitis (adequately diagnosed)
- Mild to moderately severe community acquired pneumonia
- Infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis,
erysipelas
- Uncomplicated Chlamydia trachomatis urethritis and cervicitis
2.3 OVERALL QUALITY SUMMARY For PPB use only
2.3.1 OVERVIEW OF ACTIVE PHARMACEUTICAL INGREDIENT(S) [API(S)]
2.3.1.1 General Information of the API(S)
2.2.1.1.1 Nomenclature : - (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-
O-methyl-a-L-ribohexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-eptamethyl-
11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1- oxa-6-
azacyclopentadecan-15-one.
For PPB use only
2.2.1.1.2 Structure
For PPB use only
2.2.1.1.3 General Properties of the API(s)
Physio-Chemical Characterization:
Physical Form : White or almost white powder.
Solubility : Practically insoluble in water,
Freely soluble in anhydrous ethanol
and in Methylene chloride.
Specific Optical rotation : - 45 to – 49 For PPB use only
2.3.1.2 Manufacture of the API(S)
2.3.1.2.1 Name and address of API(s) Manufacturer
MEHTA PHARMACEUTICAL INDUSTRIES
Unit No. III, Kopri Village Naka, Veer Savarkar Marg, Chandansar, Virar (East),401 305 Dist. Thane,(M.S.)
For PPB use only
2.3.1.2.2 Description of Manufacturing Process and Process Controls - This information pertains to closed part DMF
only.
2.3.1.2.3 Control of Materials used in Manufacture of API - This information pertains to closed part DMF only.
2.3.1.2.4 Controls of Critical Steps and Intermediates- This information pertains to closed part DMF only.
2.2.1.2.5 Process Validation and/or Evaluation- This information pertains to closed part DMF only.
For PPB use only
2.3.1.3 Characterization of the API(S)
Azithromycin is reported in British Pharmacopoeia. Each batch is routinely identified.
The structure of Azithromycin was separately elucidated by Elemental analysis, UV
spectrum, IR spectrum, NMR spectrum and Mass spectrum studies, refer Section
3.2.S.3.1 of DMF
Azithromycin is powder in nature.
The impurity limits are based upon British Pharmacopoeia monograph. For details refer
the section 3.2.S.3.2 of DMF
2.3.1.4 Control of the API(S))
Azithromycin is official in British Pharmacopoeia. Specification of Azithromycin is as
per in British Pharmacopoeia. The methods followed are also exactly those of the British
Pharmacopoeia The limits specified for Residual solvent are those of the ICH guidelines.
For detail information refer DMF, Section 3.2.S.4
2.3.1.5 Reference Standards or Materials of the API(S)
For Reference standard details and COA refer DMF section 3.2.S.5
2.3.1.6 Container Closure System of the API(S)
The material is packed in food grade double polythene bags. (Inner white and outer
black) which is then packed in HDPE drums.
2.3.1.7 Stability of the API(S)
Stability study was initiated on marketable production batches samples.
The study was performed:
Long term study at 25°C ± 2°C and 60 % + 5 % RH.at an interval of initial, 3,
6 ,9,12,18,24,36 ,48 and 60month.
Accelerated Stability Study at 40°C + 2°C and 75 % + 5 % RH at an interval of initial, 1,
3 and 6 month.
Test carried out:
1. Description
2. Solubility
3. Identification
4. Appearance of solution
5. pH
6. Specific optical rotation
7. Related substances
8. Heavy Metals
9. Water
10. Sulphated ash
11. Assay
For detail information, refer DMF, section 3.2.S.7.3
For PPB use only
2.3.2 OVERVIEW OF FINISHED PHARMACEUTICAL PRODUCT(S) [FPP(S)]
Description and Composition of the FPP(S)
Orange colour, oval shape film coated tablets with both sides plain.
Composition:
Each film-coated tablet Contains:
Azithromycin Dihydrate
Eqv. to Azithromycin BP 500 mg
Approved Colour used.
Type of Container closure system:
1x 3 (3 tablets in one blister, such 1 blister is packed in one Carton)
Sr. No. Ingredients and specifications Qty./Tab in
mg
Function
1
Azithromycin Dihydrate B.P. eq. to
Azithromycin base B.P.
550.0 Active
2 Maize Starch BP 56.781 Binder
3 Lactose BP 30.00 Filler
4 Microcrystalline Cellulose BP 10.00 Diluent
5 Polyvinylpyrrolidone K 30 BP 14.00 Binder
6 Colloidal silicon dioxide BP 1.00 Glidant
7 Magnesium Stearate BP 8.00 Lubricant
8 Cross povidone BP 20.00 Disintegrant
9 Talcum BP 10.0 Glidant
10 Purified water BP 0.124 ml Vehicle
11 Titanium Dioxide BP 2.94 Pigment
12 Polyethylene glycol 400 USP 4.90 Plasticizer
13 Isopropyl Alcohol BP 0.1178 Solvent
14 Hydroxypropyl methylcellulose BP 12.376 Film former
15 Propylene Glycol BP 2.94 Solvent
16 Colour Sunset yellow IHS 0.0495 Colorant
17 Methylene Chloride 0.2970 Solvent
2.3.2.2 Pharmaceut1ical Development of the FPP(S)
To develop a robust, stable formulation of AZYCIN-500 which is pharmaceutical
equivalent and to optimize the manufacturing formula of AZYCIN-500.
The final formulation of the drug product is shown in Dossier, section 2.3 2.1.
The details of the study is provided in Dossier, section 3.2.2.2
2.3.2.3 Manufacture of the FPP(S)
Mfg’s Name : NEM LABORATORIES (P) LTD.
Address : 133, Krishna Indl. Estate,
Navghar, Vasai Road (E),
Thane - 401 210. Maharashtra
INDIA.
Phone : + 91 (250) 2390002/03/3386/2798
Fax : + 91 (250) 2392905, 2393046
2.3.2.4 Control of Excipients for the FPP(S)
All excipients were control based on Pharmacopoeial monograph.
Selection of excipients describes all the tests and acceptance criteria. For details, refer the
Dossier, section 3.2. 2.4.1
2.3.2.5 Control of the FPP(S)
AZYCIN-500 (Azithromycin Tablets 500) is In-House specific. Specification of all tests
done are set as per In-house specifications. For details, refer the Dossier, section 3.2.2.5
2.3.2.6 Reference Standards or Materials of the FPP(S)
For the analysis of AZYCIN-500 (Azithromycin Tablets 500) working standard is used. A
certificate of analysis is included, which is valid for one year. Every year new working
standard is prepared from a commercial batch sample and compared with the standard
material. For detail, refer the Dossier, section 3.2.2.5.
2.3.2.7 Container Closure System of the FPP(S)
PRIMARY PACKAGING MATERIAL: P.V.C. Film, Aluminum foil.
2.3.2.8 Stability of the FPP(S)
Batch selection:
The following batches were submitted to the stability study:
Batch no. Mfg. date Study
initiated on
Intervals tested and Stability study condition
AZI-1 Jul.2010 27/07/2010
Intervals Long term: Initial, 3, 6,9,12,18,24 and 36 and
36 month
Intervals Accelerated: Initial, 1, 2, 3 and 6
month
Long term: 300C+20C / 65%+5%
Accelerated: 400C+20C / 75%+5%
AZI-2 Sep.2010 29/09/2010
AZI-3 Oct.2010 01/10/2010
2.3.3 APPENDICES
2.3.3.1 Facilities and Equipment - NOT APPLICABLE
2.3.3.2 Adventitious Agents Safety Evaluation - NOT APPLICABLE
2.3.3.3 Novel Excipients -NOT APPLICABLE For PPB use only
2.4 SUMMARY OF NON-CLINICAL DOCUMENTATION AND CLINICAL
DOCUMENTATION
2.4.1 FOR NEW CHEMICAL ENTITIES
2.4.1.1 Non-clinical overview - NOT APPLICABLE
2.4.1.2 Non-clinical written and tabulated summaries- NOT APPLICABLE
2.4.1.3 Clinical overview- NOT APPLICABLE
2.4.1.3 Clinical summary- NOT APPLICABLE For PPB use only
2.4.2 GENERIC DRUG APPLICATIONS
2.4.2.1 Clinical Overview and Summary - NOT APPLICABLE
2.4.2.1.1 Product Development Rationale - NOT APPLICABLE
2.4.2.1.2 Overview of Biopharmaceutics Studies- NOT APPLICABLE
2.4.2.1.3 Summary of Biopharmaceutics Studies and Associated Analytical Methods - NOT APPLICABLE
2.4.2.1.4 Overview and Summary of In Vitro Dissolution Tests complementary to Bioequivalence Studies- NOT
APPLICABLE
2.4.2.1.4 Overview and Summary of In Vitro Dissolution Tests in support of a Biowaiver – Refer Dossier, Section
5.2.1.2
For PPB use only For PPB use only
OVERALL QUERIES AND RECOMMENDATIONS FOR THIS MODULE
MODULE 3: CHEMICAL-PHARMACEUTICAL DOCUMENTATION
3.1 TABLE OF CONTENTS OF MODULE 3
3.2 BODY OF DATA
3.2.1 PARTICULARS OF ACTIVE PHARMACEUTICAL INGREDIENT(s) [API(s)]
3.2.1.1 General Information of the API(S)
3.2.1.1.1 Nomenclature
Recommended International : Azithromycin
Non-proprietary Name
Chemical Name : (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl-a-L-
ribohexopyranosyl)oxy]-2-ethyl-
3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-
trideoxy-3-(dimethylamino)-β-D-xylo
-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan--
15-one.
Compendial names : Azithromycin
[CAS] Registry number : [83905-01-5].
3.2.1.1.2 Structure
Molecular formula : C38H72N2O12, H2O
Molecular Weight : 749
Structural formula
:
3.2.1.1.3 General Properties of API(s)
Physio-Chemical Characterization:
Physical Form : White or almost white powder.
Solubility : Practically insoluble in water,
Freely soluble in anhydrous ethanol
and in Methylene chloride.
Specific Optical rotation : - 45 to – 49
3.2.1.2 Manufacture of the API(S)
Name and Address of : MEHTA PHARMACEUTICAL INDUSTRIES
Manufacturing Facility Unit No. III, Kopri Village Naka,
Veer Savarkar Marg,
Chandansar,
Virar (East),401 305
Dist. Thane,(M.S.)
3.2.1.3 Characterization of the API(S)
Azithromycin is reported in British Pharmacopoeia. Each batch is routinely identified.
The structure of Azithromycin was separately elucidated by Elemental analysis, UV
spectrum, IR spectrum, NMR spectrum and Mass spectrum studies, refer Section 3.2.S.3.1 of DMF
Azithromycin is powder in nature.
The impurity limits are based upon British Pharmacopoeia monograph.
For details refer the Dossier, section 3.2.1.3
3.2.1.4 Control of the API(S))
Azithromycin is official in British Pharmacopoeia. Specification of Azithromycin is as per in
British Pharmacopoeia. The methods followed are also exactly those of the British Pharmacopoeia
The limits specified for Residual solvent are those of the ICH guidelines.
For detail information refer Dossier, Section 3.2.1.4
3.2.1.5 Reference Standards or Materials of the API(S)
For details refer the Dossier, section 3.2.1.5
3.2.1.6 Container Closure System of the API(S)
The primary packing components are food grade and nontoxic having prime virgin properties.
Following are the list of packaging material used for the packing of finished product.
1. Polythene bag (Low density) (Suitable to 25 Kg and 50 Kg pack)
2. HDPE drum (10mm x 10mm x 10mm)
3.2.1.7 Stability of the API(S)
I] Long Term Stability Study:(REALTIMESTABILITYSTUDY)
Long Term stability study was initiated on marketable production batches samples. The samples are
packed in double polythene bags and then preserved in HDPE drums in a manner that it simulates the
marketed packing at 25 ± 2°C and 60%+ 5 %RH).
From February 2010 storage condition is changed to (30 ± 2°C and 65%+ 5 %RH) as per WHO guideline
for climatic zone III rd and IV th. They are protected from light. The samples preserved as above are
analysed after every 3 months for the first year. The study is scheduled to be conducted every 6 months for
the second year. Thereafter, it shall be analysed annually for the third, fourth and fifth year. The analysis is
scheduled up to 60 months (i.e. up to expiry of drug substance).
II] Accelerated Stability Study (40 oC + 2 oC and 75%+ 5 %RH)
The above samples were also subjected to stability testing at accelerated conditions of 40 oC + 2 oC and
75%+ 5 %RH. This study was conducted on the samples preserved at the above conditions and were
analysed after every month for first 3months and then after 6months.
Test carried out:
1. Appearance
2. Solubility
3. Identification
4. Appearance of solution
5. pH
6. Specific optical rotation
7. Related substances
8. Heavy Metals
9. Water
10. Sulphated ash
11. Assay
Conclusion: From the data of accelerated stability study (6months) and those of long term stability
study of marketable production batches (up to 60 months) it can be concluded that the product is
quite stable up to 60months.
For Details, refer Dossier, section 3.2.1.7
3.2.2 PARTICULARS OF FINISHED PHARMACEUTICAL PRODUCT(S) [FPP(S)]
3.2.2.1 Description and Composition of the FPP(S) - Refer Dossier, section 3.2.2.1
3.2.2.2 Pharmaceutical Development of the FPP(S) - Refer Dossier, section 3.2.2.2
3.2.2.3 Manufacture of the FPP(S) - Refer Dossier, section 3.2.2.3
3.2.2.4 Control of Excipients for the FPP(S) - Refer Dossier, section 3.2.2.4
3.2.2.5 Control of the FPP(S) - Refer Dossier, section 3.2.2.5
3.2.2.6 Reference Standards or Materials of the FPP(S) - Refer Dossier, section 3.2.2.6
3.2.2.7 Container Closure System of the FPP(S) - Refer Dossier, section 3.2.2.7
3.2.2.8 Stability of the FPP(S) - Refer Dossier, section 3.2.2.8
3.2.3 APPENDICES
3.2.3.1 Facilities and Equipment - Not Applicable 3.2.3.2 Adventitious Agents Safety Evaluation- Not Applicable
3.2.33 Novel Excipients- Not Applicable
MODULE 4: NON-CLINICAL STUDY REPORTS FOR NEW CHEMICAL
ENTITIES ONLY
4.1 TABLE OF CONTENTS OF MODULE 4
4.2 STUDY REPORTS - Not Applicable
4.3 LITERATURE REFERENCES- Not Applicable as our product is not a new chemical entity.
MODULE 5: CLINICAL STUDY REPORTS
5.1 NEW CHEMICAL ENTITIES ONLY 5.1.1 Table of Contents of Module 5 - Not Applicable
5.1.2 Tabular Listing of All Clinical Studies - Not Applicable
5.1.3 Clinical Study Reports - Not Applicable
5.1.4 Literature References- Not Applicable
5.2 INTERCHANGEABILITY OF GENERIC DRUGS – (GENERIC DRUG
APPLICATIONS ONLY)
5.2.1 REPORTS OF BIOPHARMACEUTIC STUDY(IES) Not Applicable
5.2.1.1 Bioavailability (BA) study report Not Applicable
5.2.1.2 In Vitro Dissolution Tests - Refer Dossier, Section 5.2.1.2
5.2.2.1.1 In vitro dissolution tests complementary to bioequivalence studies Not Applicable
5.2.2.1.2 In vitro dissolution tests in support of biowaiver Not Applicable
5.2.3 Other Clinical study data done to support efficacy and safety of the product – Published literature enclosed in
Dossier
5.3 SAFETY AND RESIDUES DOCUMENTATION (FOR VETERINARY PRODUCTS
ONLY) – Not Applicable 5.3.1 Requirements for Animal Safety - Not Applicable
5.3.1.1 Laboratory Animal Studies- Not Applicable
5.3.1.2 Target Animal Safety Studies- Not Applicable
5.3.2 Requirements for Human Safety- Not Applicable
5.3.2.1 Laboratory Animal Toxicity Studies- Not Applicable
5.3.2.2 Microbiological Safety Studies (for antimicrobial products) - Not Applicable
5.3.2.3 Veterinary Antimicrobial Products - Not Applicable
5.3.2.4 Residue (Chemistry) Studies/data for food producing species only- Not Applicable
DECLARATION BY AN APPLICANT
1. I, the undersigned certify that all the information in this application form and accompanying
documentation is correct, complete and true to the best of my knowledge.
2. I further confirm that the information referred to in my application dossier is available for
verification during current GMP inspection.
3. I agree that the undersigned has not marketed or advertised this product in Kenya and will follow
the PPB requirements for advertisements of medicines.
4. I also agree that I am obliged to follow the requirements of the Pharmacy and Poisons Act, which
are related to pharmaceutical products.
5. I also consent to the processing of information provided by the Pharmacy and Poisons Board.
Name: Mr. DHAVAL A. TALATI
Position in the company: DIRECTOR
Signature:
Date:31/05/2017
Official stamp: