Transcript PowerPoint Template - Centaur Pharmaceuticals

We Impart
Health to Life
Provide end-to-end pharmaceuticals
solutions
Centaur Pharmaceuticals Pvt. Ltd.
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We Impart Health to Life
Why Centaur
Formulations
• Contract R&D
• Reach:10,000 Drs/pharmacies per day in India
API
• USFDA, AFSSAPS approved
• Custom Synthesis
• Contract Manufacturing
Contract
Manufacturing
• US FDA, UK-MHRA, TGA inspected
• Oral solids, Ophthalmologicals
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Clinical
Research
• BA/BE studies
• Clinical trials
We Impart Health to Life
Corporate
Business Spread (Sales)
Formulations
78%
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API
22%
Geographical Spread (Sales)
Domestic
80%
International
20%
We Impart Health to Life
Corporate
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Established 1978
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One of India’s few fully integrated
pharmaceutical organizations
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Competencies across the
pharmaceutical value chain
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Building relationships with global
pharmaceutical majors
Foot print encompasses 95
countries, including regulated
markets
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We Impart Health to Life
API
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Manufacturing facility situated at
Ambernath – 60 kms from Mumbai.
•
India's largest Psychotropic API
manufacturer
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Introduced 28 API for the 1st time in
India
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Facility approved by US FDA /
AFSSAPS, WHO-GMP
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API - Conceptualization to
Commercialization
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ISO 9001 - 2008; ISO 14001:2004 &
OHSAS 18001:2007 certified facility.
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Skill set
API
Intermediates
Process Chemistry
Custom Synthesis
We Impart Health to Life
API- Reaction Capabilities
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Alkylation
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Amidation
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Alcohols to chlorides
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Bromination
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Chlorination
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Cyanation
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Reduction
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Oxidation
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Organo-metallic reaction
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Phase transfer catalyst mediated
reactions
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Diazotisation reactions
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Chiral resolution & racemisation
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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
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Polymorphism
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Expertise in developing API processes with desired polymorph.
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Commercialised several API processes with customized/ noninfringing polymorphs & pseudo polymorphs
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A separate polymorphic lab having instrumentation such as
XRD, DSC, TGA, IR and Polarimeter
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We Impart Health to Life
API - R & D - Key Attributes
• Access to scientific databases
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SciFinder
STN
• Network with leading academic institutions
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National Chemical Laboratory (NCL, Pune)
Indian Institute of Technology (IIT, Mumbai)
University Institute of Chemical Technology (UICT, Mumbai)
• Other important milestones
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(DST),
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Recognition from Department of Science & Technology
Government of India, Since 2005
Recognition from University of Pune for advance studies.
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We Impart Health to Life
API- MILESTONES
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AFSSAPS French Authorities approval – 2008/2011.
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US FDA approval – 2008/2011.
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PMDA Japan - Accreditation Certificate - 2008.
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WHO-GMP Certification – 2009.
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ISO 9001: 2008 Certification - 2001.
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ISO 14001:2004 & OHSAS 18001:2007 Certification - 2010.
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COS approval by EDQM – 11 products
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We Impart Health to Life
FORMULATIONS - CONTRACT MANUFACTURING
FACILITY OVERVIEW
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FORMULATIONS - CONTRACT MANUFACTURING
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Facility situated at Pune – 140 kms away from Mumbai
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Fully scalable 25,000 square meters area
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3 billion tablets & 600 million capsules pa
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1200 square meters formulation & analytical development section
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On the anvil, Ophthalmic –12 million units pa
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Facility to handle moisture-sensitive products <20% RH
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Flexibility of 7.5 kg to 1000 kgs batch size
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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.
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We Impart Health to Life
FORMULATIONS – CONTRACT MANUFACTURING
Packaging:
 5 Blister Packing Area(s) : PVC ,PVC / PVdC , Alu - Alu
 Bulk Packing Area
 Strip Packing Area
 Online Secondary Packing Area
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FORMULATIONS – CONTRACT MANUFACTURING-MILESTONES
•
US FDA Inspected - 2011
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UK MHRA approval - 2010
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TGA Australia approval - 2010
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WHO-GMP approval - 2009
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We Impart Health to Life
FORMULATIONS
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Latin America, Caribbean, Africa, Asia
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India: over 50 million Rx annually
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Brand leadership in 6 therapy
segments
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Reach:10,000 Drs & 10,000
pharmacies per day
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Sinarest: Anti-cold brand leader since
1997, 1 Rx every second
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We Impart Health to Life
CLINICAL RESEARCH
• LifeSan is a division of Centaur • BA – BE studies
• State-of-the-art bioanalytical unit • Clinical Trials- Phase II/III/IV
• 42 beds CPU, fully-equipped ICU • Staff Strength of 50
• Pharmacokinetic evaluation – WinNonlin 5.2
• Statistical Analysis –SAS 9.2
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CLINICAL RESEARCH – CLINICAL DEPT
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Area of 7000 sq.ft.
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A fully equipped 2-bed ICU with critical care instrumentation
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Biometric software with fingerprinting for unique identification of
volunteers
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Triple-access controlled drug store facility with humidity chamber,
refrigerator & LAF for dispensing
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CLINICAL RESEARCH – BIOANALYTICAL DEPT
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Area of 3500 sq.ft.
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Dedicated areas for Solid Phase
(positive pressure) & liquid-liquid
extraction, protein precipitation and
sample analysis
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Bioanalytical methods - 82
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SDMS software for chromatographic
data capture & back-up
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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
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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
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OUR STRENGTH-1850 CENTAURIANS
API
140
HO
210
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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%
20%
2010
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2015
We Impart Health to Life
Let us build the future
…..together
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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
[email protected]
www.centaurpharma.com/api
Formulations
[email protected]
www.centaurpharma.com
Contract
[email protected]
Manufacturing
www.centaurpharma.com
Clinical
Research
www.lifesan.in
[email protected]
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We Impart Health to Life