c69230e3d3168562ba82174abd9b5936.ppt
- Количество слайдов: 24
We Impart Health to Life Provide end-to-end pharmaceuticals solutions Centaur Pharmaceuticals Pvt. Ltd. www. centaurpharma. com We Impart Health to Life
Why Centaur • Contract R&D Formulations • Reach: 10, 000 Drs/pharmacies per day in India API • USFDA, AFSSAPS approved • Custom Synthesis • Contract Manufacturing • US FDA, UK-MHRA, TGA inspected • Oral solids, Ophthalmologicals www. centaurpharma. com Clinical Research • BA/BE studies • Clinical trials We Impart Health to Life
Corporate Business Spread (Sales) Formulations 78% www. centaurpharma. com API 22% Geographical Spread (Sales) Domestic 80% International 20% We Impart Health to Life
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
API • Manufacturing facility situated at Ambernath – 60 kms from Mumbai. • India's largest Psychotropic API manufacturer • Introduced 28 API for the 1 st 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. www. centaurpharma. com Skill set API Intermediates Process Chemistry Custom Synthesis We Impart Health to Life
API- Reaction Capabilities Ø Ø Ø Ø Alkylation Amidation Alcohols to chlorides Bromination Cyanation Reduction www. centaurpharma. com Ø Ø Ø Oxidation Ø Ø Ø Chlorination Diazotisation reactions Organo-metallic reaction Phase transfer catalyst mediated 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, We Impart Health to Life
API- Reaction Capabilities Ø Polymorphism § Expertise in developing API processes with desired polymorph. § Commercialised several API processes with customized/ noninfringing polymorphs & pseudo polymorphs § A separate polymorphic lab having instrumentation such as XRD, DSC, TGA, IR and Polarimeter www. centaurpharma. com We Impart Health to Life
API - R & D - Key Attributes • Access to scientific databases Ø Ø Sci. Finder STN • Network with leading academic institutions Ø Ø Ø National Chemical Laboratory (NCL, Pune) Indian Institute of Technology (IIT, Mumbai) University Institute of Chemical Technology (UICT, Mumbai) • Other important milestones Ø (DST), Ø Recognition from Department of Science & Technology Government of India, Since 2005 Recognition from University of Pune for advance studies. www. centaurpharma. com We Impart Health to Life
API- MILESTONES q q q q 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 www. centaurpharma. com We Impart Health to Life
FORMULATIONS - CONTRACT MANUFACTURING FACILITY OVERVIEW www. centaurpharma. com We Impart Health to Life
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
FORMULATIONS CONTRACT MANUFACTURING Ø Four Granulation area (s): Wet /Dry – Planned Capacity 2000 Kg/ Shift. Ø Eight Compression area (s) Planned Capacity 10 Million/ Shift. Ø Five coating area (s): Sugar/Film/Enteric/ Aqueous and solvent based. Ø Two capsule filling area (s) Planned Capacity 2 Million/ Shift. www. centaurpharma. com We Impart Health to Life
FORMULATIONS – CONTRACT MANUFACTURING Packaging: Ø 5 Blister Packing Area(s) : PVC , PVC / PVd. C , Alu - Alu Ø Bulk Packing Area Ø Strip Packing Area Ø Online Secondary Packing Area www. centaurpharma. com We Impart Health to Life
FORMULATIONS – CONTRACT MANUFACTURING-MILESTONES • • UK MHRA approval - 2010 • TGA Australia approval - 2010 • www. centaurpharma. com US FDA Inspected - 2011 WHO-GMP approval - 2009 We Impart Health to Life
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 www. centaurpharma. com We Impart Health to Life
CLINICAL RESEARCH • Life. San is a division of Centaur • BA – BE studies • State-of-the-art bioanalytical unit • Clinical Trials- Phase II/IV • 42 beds CPU, fully-equipped ICU • Staff Strength of 50 • Pharmacokinetic evaluation – Win. Nonlin 5. 2 • Statistical Analysis –SAS 9. 2 www. centaurpharma. com We Impart Health to Life
CLINICAL RESEARCH – CLINICAL DEPT Ø Area of 7000 sq. ft. Ø A fully equipped 2 -bed ICU with critical care instrumentation Ø Biometric software with fingerprinting for unique identification of volunteers Ø Triple-access controlled drug store facility with humidity chamber, refrigerator & LAF for dispensing www. centaurpharma. com 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 www. centaurpharma. com We Impart Health to Life
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
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
OUR STRENGTH-1850 CENTAURIANS API 140 www. centaurpharma. com HO 210 Formulations 450 Sales 1000 CRO 50 We Impart Health to Life
CENTAUR’S GROWTH STRATEGY API Formulations Clinical Research Contract Manufacturing 5% 20% 80% 40% 35% 2010 www. centaurpharma. com 2015 We Impart Health to Life
Let us build the future …. . together www. centaurpharma. com We Impart Health to Life
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 Business E mail Website API export@centaurchem. com www. centaurpharma. com/api Formulations export@centaurchem. com www. centaurpharma. com Contract centaur_pune@centaurlab. com Manufacturing www. centaurpharma. com Clinical Research www. lifesan. in lifesan@lifesan. in www. centaurpharma. com We Impart Health to Life


