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Www.centaurpharma.com We Impart Health to Life Provide end-to-end pharmaceuticals solutions Centaur Pharmaceuticals Pvt. Ltd. www.centaurpharma.com We.

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Presentation on theme: "Www.centaurpharma.com We Impart Health to Life Provide end-to-end pharmaceuticals solutions Centaur Pharmaceuticals Pvt. Ltd. www.centaurpharma.com We."— Presentation transcript:

1 We Impart Health to Life Provide end-to-end pharmaceuticals solutions Centaur Pharmaceuticals Pvt. Ltd. We Impart Health to Life

2 We Impart Health to Life USFDA, AFSSAPS approved Custom Synthesis Contract Manufacturing BA/BE studies Clinical trials Contract R&D Reach:10,000 Drs/pharmacies per day in India US FDA, UK-MHRA, TGA inspected Oral solids, Ophthalmologicals Why Centaur API Contract Manufacturing Clinical Research Formulations

3 We Impart Health to Life Business Spread (Sales) Domestic 80% International 20% Geographical Spread (Sales) Formulations 78% API 22% Corporate

4 We Impart Health to Life Established 1978 One of Indias few fully integrated pharmaceutical organizations Competencies across the pharmaceutical value chain Building relationships with global pharmaceutical majors Foot print encompasses 95 countries, including regulated markets We Impart Health to Life Corporate

5 We Impart Health to Life Manufacturing facility situated at Ambernath – 60 kms from Mumbai. India's largest Psychotropic API manufacturer Introduced 28 API for the 1st time in India Facility approved by US FDA / AFSSAPS, WHO-GMP API - Conceptualization to Commercialization ISO ; ISO 14001:2004 & OHSAS 18001:2007 certified facility. API Intermediates Process Chemistry Custom Synthesis Skill set API

6 We Impart Health to Life API- Reaction Capabilities Alkylation Amidation Alcohols to chlorides Bromination Chlorination Cyanation Reduction Oxidation Organo-metallic reaction Phase transfer catalyst mediated reactions Diazotisation reactions Chiral resolution & racemisation Name other reactions: Aldol reaction, Claisen ondensation, Friedel craft reaction, Mannich reaction, Michael addition, Sandmeyer reaction, Suzuki coupling, Vilsmeier Haack reaction,

7 We Impart Health to Life Polymorphism Expertise in developing API processes with desired polymorph. Commercialised several API processes with customized/ non- infringing polymorphs & pseudo polymorphs A separate polymorphic lab having instrumentation such as XRD, DSC, TGA, IR and Polarimeter API- Reaction Capabilities

8 We Impart Health to Life API - R & D - Key Attributes Access to scientific databases SciFinder STN Network with leading academic institutions National Chemical Laboratory (NCL, Pune) Indian Institute of Technology (IIT, Mumbai) University Institute of Chemical Technology (UICT, Mumbai) Other important milestones Recognition from Department of Science & Technology (DST), Government of India, Since 2005 Recognition from University of Pune for advance studies.

9 We Impart Health to Life API- MILESTONES AFSSAPS French Authorities approval – 2008/2011. US FDA approval – 2008/2011. PMDA Japan - Accreditation Certificate WHO-GMP Certification – ISO 9001: 2008 Certification ISO 14001:2004 & OHSAS 18001:2007 Certification COS approval by EDQM – 11 products

10 We Impart Health to Life FORMULATIONS - CONTRACT MANUFACTURING FACILITY OVERVIEW

11 We Impart Health to Life FORMULATIONS - CONTRACT MANUFACTURING We Impart Health to Life Facility situated at Pune – 140 kms away from Mumbai Fully scalable 25,000 square meters area 3 billion tablets & 600 million capsules pa 1200 square meters formulation & analytical development section On the anvil, Ophthalmic –12 million units pa Facility to handle moisture-sensitive products <20% RH Flexibility of 7.5 kg to 1000 kgs batch size

12 We Impart Health to Life FORMULATIONS CONTRACT MANUFACTURING Four Granulation area (s): Wet /Dry – Planned Capacity 2000 Kg/ Shift. Eight Compression area (s) Planned Capacity 10 Million/ Shift. Five coating area (s): Sugar/Film/Enteric/ Aqueous and solvent based. Two capsule filling area (s) Planned Capacity 2 Million/ Shift.

13 We Impart Health to Life FORMULATIONS – CONTRACT MANUFACTURING 5 Blister Packing Area(s) : PVC,PVC / PVdC, Alu - Alu Bulk Packing Area Strip Packing Area Online Secondary Packing Area Packaging:

14 We Impart Health to Life FORMULATIONS – CONTRACT MANUFACTURING-MILESTONES US FDA Inspected UK MHRA approval TGA Australia approval WHO-GMP approval

15 We Impart Health to Life Latin America, Caribbean, Africa, Asia India: over 50 million Rx annually Brand leadership in 6 therapy segments Reach:10,000 Drs & 10,000 pharmacies per day Sinarest: Anti-cold brand leader since 1997, 1 Rx every second FORMULATIONS

16 We Impart Health to Life CLINICAL RESEARCH LifeSan is a division of Centaur State-of-the-art bioanalytical unit 42 beds CPU, fully-equipped ICU BA – BE studies Clinical Trials- Phase II/III/IV Staff Strength of 50 Pharmacokinetic evaluation – WinNonlin 5.2 Statistical Analysis –SAS 9.2

17 We Impart Health to Life CLINICAL RESEARCH – CLINICAL DEPT Area of 7000 sq.ft. A fully equipped 2-bed ICU with critical care instrumentation Biometric software with fingerprinting for unique identification of volunteers Triple-access controlled drug store facility with humidity chamber, refrigerator & LAF for dispensing

18 We Impart Health to Life CLINICAL RESEARCH – BIOANALYTICAL DEPT Area of 3500 sq.ft. Dedicated areas for Solid Phase (positive pressure) & liquid-liquid extraction, protein precipitation and sample analysis Bioanalytical methods - 82 SDMS software for chromatographic data capture & back-up

19 We Impart Health to Life CLINICAL RESEARCH – SERVICES OFFERED We Impart Health to Life Bioavailability/ Bioequivalence studies involving male and female volunteers Studies for determination of the Absolute Bioavailability Drug-Drug interaction Studies Clinical Trials – Phase II, III & IV Applied services to Drug Development Programs Assistance in ANDA Filings Complete Documentation – Dossier preparation Regulatory Assistance – DCGI/ ICMR/ CBN/ other countries

20 We Impart Health to Life CLINICAL RESEARCH – FUTURE PLANS BA/BE studies – - in special populations, - multiple-dose steady state, - Pharmacokinetics of targeted drug- delivery - Dermatology bioequivalence study Data management cell We Impart Health to Life

21 We Impart Health to Life OUR STRENGTH-1850 CENTAURIANS API 140 HO 210 Formulations 450 Sales 1000 CRO 50

22 We Impart Health to Life 20% 80% CENTAURS GROWTH STRATEGY API Formulations Clinical Research Contract Manufacturing 35% 5% 20% 40%

23 We Impart Health to Life Let us build the future …..together

24 We Impart Health to Life Centaur Pharmaceuticals Pvt. Ltd. Centaur House, Near Grand Hyatt, Vakola, Santacruz (E), Mumbai INDIA Tel. : Fax : / 182 BusinessE mailWebsite Contract Manufacturing Clinical Research Contact


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