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Provide end-to-end pharmaceuticals solutions

Provide end-to-end pharmaceuticals solutions. We Impart Health to Life. Centaur Pharmaceuticals Pvt. Ltd. www.centaurpharma.com. Clinical Research. Why Centaur. Contract R&D Reach:10,000 Drs/pharmacies per day in India. Formulations. USFDA, AFSSAPS approved Custom Synthesis

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Provide end-to-end pharmaceuticals solutions

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

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

  3. Corporate Business Spread (Sales) Geographical Spread (Sales) International 20% API 22% Domestic 80% Formulations 78%

  4. Corporate • Established 1978 • One of India’s 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 www.centaurpharma.com We Impart Health to Life

  5. API Skill set • 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 9001 - 2008; ISO 14001:2004 & OHSAS 18001:2007 certified facility. API Intermediates Process Chemistry Custom Synthesis

  6. 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. API- Reaction Capabilities • 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

  8. 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. API- MILESTONES • AFSSAPS French Authorities approval – 2008/2011. • US FDA approval – 2008/2011. • PMDA Japan - Accreditation Certificate - 2008. • WHO-GMP Certification – 2009. • ISO 9001: 2008 Certification - 2001. • ISO 14001:2004 & OHSAS 18001:2007 Certification - 2010. • COS approval by EDQM – 11 products

  10. FORMULATIONS - CONTRACT MANUFACTURING FACILITY OVERVIEW

  11. FORMULATIONS - CONTRACT MANUFACTURING • 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 www.centaurpharma.com We Impart Health to Life

  12. 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. FORMULATIONS – CONTRACT MANUFACTURING Packaging: • 5 Blister Packing Area(s) : PVC ,PVC / PVdC , Alu - Alu • Bulk Packing Area • Strip Packing Area • Online Secondary Packing Area

  14. FORMULATIONS – CONTRACT MANUFACTURING-MILESTONES • US FDA Inspected - 2011 • UK MHRA approval - 2010 • TGA Australia approval - 2010 • WHO-GMP approval - 2009

  15. FORMULATIONS • 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

  16. 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. 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. 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. CLINICAL RESEARCH – SERVICES OFFERED 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 www.centaurpharma.com We Impart Health to Life

  20. 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 www.centaurpharma.com We Impart Health to Life

  21. API 140 HO 210 Formulations 450 Sales 1000 CRO 50 OUR STRENGTH-1850 CENTAURIANS

  22. CENTAUR’S GROWTH STRATEGY API Formulations Clinical Research Contract Manufacturing 5% 20% 40% 35% 80% 20% 2010 2015

  23. Let us build the future …..together

  24. Contact Centaur Pharmaceuticals Pvt. Ltd. Centaur House, Near Grand Hyatt, Vakola, Santacruz (E), Mumbai-400 055. INDIA Tel. : +91-22-664 99100 Fax : +91-22-664 99112 / 182

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