www.centaurpharma.com we impart health to life provide end-to-end pharmaceuticals solutions centaur...
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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 Impart Health to Life
www.centaurpharma.com 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
APIAPI
Contract Manufacturing
Clinical Research
Formulations
www.centaurpharma.com We Impart Health to Life
Business Spread (Sales)
Domestic80%
International20%
Geographical Spread (Sales)
Formulations78%
API 22%
Corporate
www.centaurpharma.com We Impart Health to Life
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
Corporate
www.centaurpharma.com 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 9001 - 2008; ISO 14001:2004 & OHSAS 18001:2007 certified facility.
API
Intermediates
Process Chemistry
Custom Synthesis
Skill set
API
www.centaurpharma.com 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,
www.centaurpharma.com 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
www.centaurpharma.com 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.
www.centaurpharma.com We Impart Health to Life
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
www.centaurpharma.com We Impart Health to Life
FORMULATIONS - CONTRACT MANUFACTURING
FACILITY OVERVIEW
www.centaurpharma.com We Impart Health to Life
FORMULATIONS - CONTRACT MANUFACTURING
www.centaurpharma.com 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
www.centaurpharma.com 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.
www.centaurpharma.com 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:
www.centaurpharma.com We Impart Health to Life
FORMULATIONS – CONTRACT MANUFACTURING-MILESTONES
• US FDA Inspected - 2011
• UK MHRA approval - 2010
• TGA Australia approval - 2010
• WHO-GMP approval - 2009
www.centaurpharma.com 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
www.centaurpharma.com 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
www.centaurpharma.com 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
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
www.centaurpharma.com 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
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
www.centaurpharma.com We Impart Health to Life
OUR STRENGTH-1850 CENTAURIANS
API140
HO210
Formulations 450
Sales 1000
CRO 50
www.centaurpharma.com We Impart Health to Life
20%
80%
CENTAUR’S GROWTH STRATEGY
2010 2015
APIAPI
FormulationsFormulations
Clinical Research Clinical Research
Contract ManufacturingContract Manufacturing
35%
5%
20%
40%
www.centaurpharma.com We Impart Health to Life
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 / 182Business E mail Website
API [email protected] www.centaurpharma.com/api
Formulations [email protected] www.centaurpharma.com
Contract Manufacturing
[email protected] www.centaurpharma.com
Clinical Research
[email protected] www.lifesan.in
Contact