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Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

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Page 1: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for
Page 2: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

about usPRECISE Group is an emerging global player in several areas of pharmaceutical manufacturing and

healthcare business. The Group was established in 1997 and now with an annual turnover of 40

million USD is among the respected pharmaceutical companies in India for manufacturing of Active

Pharmaceutical Ingredients (API), Pellets and Finished Pharmaceutical Formulations.

Based in Mumbai, the Group�s strength lies in providing it�s customers with end-to-end solution to

their various pharmaceutical product needs. It started with Bulk Drug manufacturing and then

diversified into Drug Pellets and Formulations.

The Group is slowly making its presence felt in the competitive healthcare market with its fair

business practices, consistent customer services and quality of medical products. It is poised to

become a leading Pharmaceutical Manufacturer in India and Internationally.

The Group now exports to almost 30 countries and it is also an approved API supplier to

manufacturers like ABBOTT, SUN PHARMA, TEVA, RANBAXY, Dr. REDDY�s, PLIVA and several other

key pharma players in the markets around the world.

“The greater danger for most of us lies not in setting our aim too high and falling short; but in setting our aim too low and achieving it.”

..... Michelangelo

Page 3: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

Mr. Pravin Shah

Chairman & Managing Director

Mr. Mehul Shah

Director

Mr. Pranay Shah

Director

Dr. Sunil Sukthankar

Director

our teamTo make available new, safe and affordable

medicine on time to people who need them the

most. We want to achieve this by continuously

adding new manufacturing facilities and

updating the product portfolio.

vision & mission

To create value for all our customers,

partners & employees while applying

environmentally safe and social

responsible business practices.mission

vision

Page 4: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

Regulatory affairs in PRECISE GROUP is a crucial link between the company, its products and regulatory authorities in international as well as domestic markets.

Typical activities by our regulatory team include:

� Keeping abreast of domestic & international legislation, guidelines and practices;

� Monitoring and setting timelines for registrations submissions, variations and renewal approvals in India and Export markets;

� Planning, developing and interpreting product clinical trial & Bioequivalence studies;

� Undertaking and managing regulatory inspections;

� Liaising with, and making presentations to, regulatory authorities domestic and internationally;

� Negotiating with regulatory authorities for marketing authorisation.

regulatory supportThe Group has developed competencies in manufacturing drugs in various therapeutic areas. All

formulations, bulk drugs and pellets are manufactured as per the international standard with

stringent technical SOP in our world class facilities. We have developed a broad portfolio of

products to care, treat and prevent diseases and lead a healthy lifestyle.

We offer end-to-end solutions to our customers with following range of products:

� FINISHED PHARMACEUTICAL FORMULATIONS

� ACTIVE PHARMACEUTICAL INGREDIENTS

� PHARMACEUTICAL INTERMEDIATES

� DRUG PELLETS

P2P BUSINESS

We offer P2P and contract manufacturing services for many new products for which we have DCGI

approvals. PRECISE has always focused on high value niche products. With challenging

technological breakthroughs, it has won itself demanding customers, who trust the group for its

transparent business practices, stringent quality control and a high level of customer service.

products / services

Page 5: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

manufacturing

To meet the ever-growing demand from its valued customers, the Group has commissioned as new state-of-the-art manufacturing facility at Nashik, Maharashtra in 2012.

This unit is a WHO-GMP Licensed Manufacturing facility for Drug Pellets, Solid Dosage and External Preparation.

A new ultra modern API and Intermediates manufacturing unit is under construction and likely to be commissioned shortly.

� Tablets

� Capsules (including Soft-Gel)

� Liquid injections

� Dry powder injections (including Lyophilized)

� Suspensions

� Liquid Oral / Dry Syrups

The group also has 2 API manufacturing units in and around Navi-Mumbai.

Range Of Finished Dosage Formulations:

infrastructure

INFRASTRUCTURE

Page 6: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

This department is the backbone and also the life force of the company. It is here that our vision and mission comes alive. Our endeavor is to undertake path-breaking research that can make our future healthcare easier and better.

It is the nerve center where we channelize our mental energies and knowledge capabilities to produce innovative solutions.

Our dream is to ensure that we meet international standards of design and developmental models for medical research. The team comprising of 100 specialized medical workers run this quiet hub with the state of the art equipment in the laboratory indulge in pre formulation studies regularly.

� Formulation development, stability and validation from all regulatory standards.

� Sustained analytical development for all research studies. � Provide its technical expertise for contract manufacturing. � Making positive changes in providing solutions for futuristic healthcare.

r & d

R & D team�s responsibilities:

quality policyWe are in the business of healthcare. To alleviate human suffering is our prime objective. Therefore, every product we produce is safe, price effective and of high quality and should be delivered to our customers on time.

We believe that quality consciousness has to be in-built in the company culture and it is achieved through:

To achieve the quality objective, we have a well-documented Quality Management System in force,

which ensures compliance with the current Good Manufacturing Practices and Best Industry

Standards.

� Stringent specifications for products

� Good product design

� Best resources

� Well-trained personnel

� Good manufacturing practices

Page 7: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

strength

Our strength is in providing end-to-end solution to our customers and partners with our broad portfolio of Bulk Drugs, Intermediates, Pellets and Formulations.

Our focus on development of new products with best of technology in Enteric Coating (EC), Sustained Release (SR) Tablets and Capsules.

Emphasis on Research & Development (R & D) to develop new products, attain better quality and affordable price.

Our vital link in the field of global medical product market is supported by our core strengths.

Established one stop solution for API, Pellets, Intermediates and Finished Formulations.

Well-trained regulatory team for preparing technical dossiers to support product registration in emerging as well as developed markets like EU and all PICS countries.

Proven skills in synthetic and analytical chemistry to develop innovative cost effective manufacturing processes.

our presence

IndiaSri LankaMayanmarCambodiaVietnamPhilippinesBangladesh

NigeriaGhanaBeninKenyaUgandaMauritaniaYemen

RussiaUkraineKazakhstanPeruVenezuelaBrazilColombia

PakistanEgyptIranSyriaJordanSingaporeTaiwan

United KingdomIsraelIndonesiaThailandTurkey

Page 8: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

Registered offices:� Precise Chemipharma Pvt. Ltd.

108, Malwa, Patanwala Ind. Estate, L.B.S. Road, Ghatkopar (West), Mumbai � 400 086. India� Precise Biopharma Pvt. Ltd.

209, Jhalawar, Patanwala Ind. Estate, L.B.S. Road, Ghatkopar (West), Mumbai � 400 086. India.

Marketing Office:302, Sai Heritage, Tilak Road, Ghatkopar (East), Mumbai � 400 077. India

Tel : + 91 22 6782 8600 / 01 - 99 ; Fax : + 91 22 2102 6418 ; Email : [email protected]

Manufacturing Units:� Unit I : C-384, T.T.C. Industrial Area, Village Pawne, Navi Mumbai � 400 703, India.� Unit II : Gut No. 215/1 & 215/2, Khatwad Phata, At Post Talegaon, Taluka Dindori,

District: Nashik � 422 202, Maharashtra, India.� Unit III : Plot No. D-90/3, Turbhe, M.I.D.C., T.T.C. Industrial Area, Navi Mumbai � 400 703, India.

Website: www.precisegroup.co.in

Thank YouProduct Pharmacopeia DMF

Agomelatine In-House -

Bepotastine Besilate In-House -

Biperiden Hydrochloride USP Available

Bosentan Monohydrate In-House -

Dabigatran Etexilate Mesylate In-House -

Dapoxetine Hydrochloride In-House -

Desvenlafaxine Succinate In-House -

Dorzolamide Hydrochloride USP Available

Etizolam JP -

Febuxostat In-House Available

Fenoxazoline Hydrochloride In-House Available

Fenspiride HCl In-House -

Fesoterodine Fumarate In-House -

Flupirtine Maleate In-House -

Ilaprazole In-House -

Levocloperastine Fendizoate In-House Available

Levodropropizine EP -

Levosimendan In-House -

Midazolam BP/EP Available

Midazolam Hydrochloride In-House Available

Midazolam Maleate In-House Available

Naphazoline Hydrochloride USP/BP/EP/IP Available

Naphazoline Nitrate BP/EP Available

Product Pharmacopeia DMF

Olopatadine Hydrochloride USP -

Omeprazole IP/BP/USP -

Oxaceprol In-House -

Pantoprazole Sodium Sequihydrate In-House/USP -

Ramosetron HCl In-House -

Rivaroxaban In-House -

Sodium Picosulphate BP/EP Available

Tapentadol Hydrochloride In-House Available

Timolol Maleate IP/USP/BP Available

Tioconazole BP / USP -

Zaleplon In-House Available

Zolpidem Hemitartrate In-House -

Zolpidem Tartrate BP/EP/IP/USP Available

ACTIVE PHARMACEUTICAL INGREDIENTS ACTIVE PHARMACEUTICAL INGREDIENTS

product listEnvironmental conservation is part of PRECISE Group�s values and therefore an essential component of our guiding principle. It is also a key factor in our efforts to design ecofriendly manufacturing processes and targeting conservation of natural resources.

Our objective is to minimize the environmental impact of our operations and activity by reducing the damage to nature.

Some initiatives under taken by the Group toward this objective are:1) Extensive tree plantation in and around the manufacturing

locations.2) Use of Biomass Briquettes in boiler and heating applications.

Biomass Briquettes are Green Boiler fuels manufactured from waste biomass like sawdust, agriculture wastes etc.

3) Putting up bird houses around the manufacturing locations for sparrows and other small birds displaces due to felling of trees and urbanization.

4) Avoid use of plastic and other non biodegradable material in packing and packaging.

ecoconcern

Page 9: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

CETRIZINE DIHYDROCHLORIDE PELLETS 3.50%

DABIGATRAN ETEXILATE MESYLATE PELLETS 40%

DEXRABEPRAZOLE SODIUM EC PELLETS 5% & 10%

DOMPERIDONE SR PELLETS 20% & 23.36%

ESOMEPRAZOLE MAGNESIUM EC PELLETS 8.5% & 22.5%

ITRACONAZOLE PELLETS 22%

LANSOPRAZOLE EC PELLETS 8.50% USP *

LANSOPRAZOLE MICRO GRANULES 8.50%

LEVOCETRIZINE DIHYDROCHLORIDE IR PELLETS 3.50%

OMEPRAZOLE EC PELLETS 8.50% USP*

ORLISTAT PELLETS 40% & 50% USP

PANTOPRAZOLE SODIUM EC PELLETS 15% & 20% *

TAMSULOSIN HCL SR PELLETS 0.15% USP

* DMF Available

Bazedoxifene

· 2-(4-(benzyloxy)phenylamino)-1-(4-(benzyloxy)phenyl)propan-1-one

· 5-(benzyloxy)-2-(4-(benzyloxy)phenyl)-3-methyl-1H-indole

Desvenlafaxine Succinate

· 1-[2-dimethylamino-1-(4-benzyloxyphenyl) ethylcyclohexanol hcl

Dorzolamide

· N-(5,6-dihydro-(S)-6 methyl-4H-thieno[2.3-b]thiopyran-4-yl) acetamide,7,7-dioxide

· (4S-trans) 4H-thieno[2.3-b] thiopyran-4-ol,5,6-dihydro-6-methyl-7,7-dioxide

· (4S-trans)-N-[2H-(aminosulfonyl)-5,6-dihydro-6-dihydro-6-methyl-7,7-dioxido-4h- thieno[2.3-b]thiopyran-4-yl]acetamide

Febuxostat

· 4-hydroxy-3-nitro benzonitrile

· 4-hydroxy benzthioamide

· Ethyl 2-(4-hydroxy)-4-methyl-5-thiazole carboxylate

· Ethyl 2-(4-isobutoxyphenyl)-4methyl-5-thiazole carboxylate

· Ethyl-2-(4-isobutoxy-3-nitrophenyl)-4-methyl thiazole carboxylate

· Ethyl 2-(4-isobutoxy-3-aminophenyl)-4-methyl thiazole carboxylate

Zaleplon

· 3-amino-4-cyanopyrazole

· n-[(3-dimethylamino)-1-oxo-2-propenyl-phenyl]-n-ethyl-acetamide

Zolpidem Tartrate

· 6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine

· 2-(4-methylphenyl)-6-methyl-imidazo[1,2-a]pyridine-3-acetonitrile

· 6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetic acid

Products protected by Patents are not offered for sale in countries, where the sale of such products constitutes patent infringements and its liability is at buyer’s risk.

DRUG PELLETS INTERMEDIATES

product listAgomelatine Tablets 25mg

Asenapine Maleate Sublingual Tablets 5mg & 10mg

Atosiban Injection 7.5mg/ml

Azelnidipine Tablets 8mg & 16mg

Bazedoxifene Tablets 20mg

Bepotastine Besilate Tablets 10mg

Bosantan Tablets 62.5mg & 125mg

Carbetocin Injection 100mcg

Dabigatran Etexilate Capsules 75mg, 110mg & 150mg

Dapoxetine Tablets 30mg & 60mg

Desvenlafaxine Tablets 50mg & 100mg

Dexrabeprazole Sodium Tablets 10mg

Dexrabprazole 10mg + Domperidone 30mg Capsules

Etizolam CR Tablets 1.5mg & 3mg

Etizolam Tablets 0.25mg, 0.5mg & 1.0mg

Febuxostat Tablets 40mg & 80mg

Fenspiride Syrup 100ml, 60ml & 30ml

Fenspiride Tablets 40mg & 80mg

Fesoterodine Fumarate Tablets 4mg & 8mg

Flupirtine Maleate Capsules 100mg

Flupirtine SR Tablets 400mg

Ilaprazole Tablets 5mg & 10mg

Levocetrizine Tablets 5mg/10mg

Levocloperastine 20mg + Chlorpheniramine Maleate 4mg Suspension

Levocloperastine Fendizoate Suspension 20mg/5ml

Linezolid Tablets 600mg

Montelukast Tablets 4mg, 5mg & 10mg

Omeprazole Capsules 20mg

Orlistat Capsules 60mg & 120mg

Pantoprazole Tablets 20mg & 40mg

Prasugrel Tablets 5mg & 10mg

Pregabalin Capsules 25 / 50 / 75 / 100 / 150 / 200 / 225 / 300mg

Ramosteron Tablets 0.1mg

Roflumilast Tablets 500mcg

Sidenafil 100mg + Dapoxetine 60mg Tablets

Tamsulosin Capsules 0.4mg

Tapentadol ER Tablets 50mg, 100mg, 150mg & 200mg

Tapentadol Tablets 50mg, 75mg & 100mg

Tioconazole Cream & Vaginal Tablets 100mg

Tranexamic Acid Tablets 500mg

Zolpidem ER Tablets 6.25mg & 12.5mg

FORMULATIONS (FOR LOCAL & EXPORT)FORMULATIONS (FOR LOCAL & EXPORT)

product list

Page 10: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

productsAmoxycilline Dry Syrup 125mg/5ml 100ml

Ampi+ Cloxacilline Syrup 250mg/5ml 100ml

Ampicilline Dry Syrup 125mg/5ml 100ml

Cefuroxime Dry Syrup 250mg/5ml 60ml

Cotrimaxole Suspension 120mg/5ml 100ml

Erythromycin Dry Syrup 125mg/5ml 100ml

Metronidiazole Suspension 100mg/5ml 100ml

Amoxy+Clavulanic 375mg 6 Tablets Alu-Alu

Amoxy+Clavulanic 625mg 6 Tablets Alu-Alu

Amoxycilline 250mg 10 Capules Blister

Cefetamet Pivoxil HCl 250mg & 500mg 4 Tablets Strip

Cefuroxime 500mg 10 Tablets Alu-Alu

Cefuroxime Axetil 250mg 10 Tablets Alu-Alu

Cefprozil 250mg 10 Tablets Blister

Ciprofloxacin 500mg 10 Tablets Blister

Diclofenac 25mg & 50mg 20 Tablets Blister

Esomeprazole+Domperodone 40mg+30mg 10 Capsules Blister

Fluconozole 100mg & 150mg 7 & 4 Tablets Blister

Ibuprofen 200mg & 400mg 10 Tablets Blister

Itraconazole 100mg 10 Capsules Blister

Lansoprazole 30mg 10 Capsules Blister

Levofloxacin 500mg 10 Tablets Alu-Alu

Levonorgestrel 0.75mg & 1.5mg 2 Tablets Blister

Mebendazole 100mg & 500mg 6 & 1 Tablet Blister

Metronidazole 200 mg & 400 mg 10 Tablets Blister

Olanzapine 10mg 10 Tablets Blister

Omeprazole 20mg 10 Capsules Blister

Orlistat 120mg 21 Capsules Blister

Paracetamol 500mg 20 Tablets Blister

Sulfadoxine & Pyrimethamine 10 Tablets Blister

Spironolactone 25mg 10 Tablets Blister

Tamsulosin SR 0.4mg 30 Capsules Blister

Tablets/Capsules/Syrups PackStrength Tablets/Capsules/Syrups PackStrength

FORMULATIONS (FOR EXPORTS ONLY) FORMULATIONS (FOR EXPORTS ONLY)

Amoxy+Clavulanic 1200 mg

Ampicilline 500 mg

Ampicilline 1000 mg

Artemether 80 mg/ml

Artesunate 80 mg

Cefepime 500 mg

Cefepime 1000 mg

Cefotaxime 500 mg

Cefotaxime 1000 mg

Ceftazidime 500 mg

Ceftazidime 1000 mg

Ceftriaxone 500 mg

Ceftriaxone 1000 mg

Cefuroxime 750 mg

Cefuroxime 1500 mg

Diclofenac 25 mg/ml

Frusemide 20 mg/ml

Meropenem 500 mg

Pantoprazole 40 mg

Piperacillin +Tazobactum 4.5 g

Ranitidine 25 mg/ml

Injections Injections Strength Strength

product list

Page 11: Precise Group - Contract Manufacturing & Healthcare ......Established one stop solution for API, Pellets, Intermediates and Finished Formulations. Well-trained regulatory team for

Registered offices:� Precise Chemipharma Pvt. Ltd.

108, Malwa, Patanwala Ind. Estate, L.B.S. Road, Ghatkopar (West), Mumbai � 400 086. India� Precise Biopharma Pvt. Ltd.

209, Jhalawar, Patanwala Ind. Estate, L.B.S. Road, Ghatkopar (West), Mumbai � 400 086. India.

Marketing Office:302, Sai Heritage, Tilak Road, Ghatkopar (East), Mumbai � 400 077. India

Tel : + 91 22 6782 8600 / 01 - 99 ; Fax : + 91 22 2102 6418 ; Email : [email protected]

Manufacturing Units:� Unit I : C-384, T.T.C. Industrial Area, Village Pawne, Navi Mumbai � 400 703, India.� Unit II : Gut No. 215/1 & 215/2, Khatwad Phata, At Post Talegaon, Taluka Dindori,

District: Nashik � 422 202, Maharashtra, India.� Unit III : Plot No. D-90/3, Turbhe, M.I.D.C., T.T.C. Industrial Area, Navi Mumbai � 400 703, India.

Website: www.precisegroup.co.in