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

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


• 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


Business Spread (Sales)

Domestic80%

International20%

Geographical Spread (Sales)

Formulations78%

API 22%

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


Corporate


• 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


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,


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


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.


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


FORMULATIONS - CONTRACT MANUFACTURING

FACILITY OVERVIEW


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


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.


FORMULATIONS – CONTRACT MANUFACTURING

5 Blister Packing Area(s) : PVC ,PVC / PVdC , Alu - Alu

Bulk Packing Area

Strip Packing Area

Online Secondary Packing Area

Packaging:


FORMULATIONS – CONTRACT MANUFACTURING-MILESTONES

• US FDA Inspected - 2011

• UK MHRA approval - 2010

• TGA Australia approval - 2010

• WHO-GMP approval - 2009


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


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


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


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


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


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



OUR STRENGTH-1850 CENTAURIANS

API140

HO210

Formulations 450

Sales 1000

CRO 50


20%

80%

CENTAUR’S GROWTH STRATEGY

2010 2015

APIAPI

FormulationsFormulations

Clinical Research Clinical Research

Contract ManufacturingContract Manufacturing

35%

5%

20%

40%


Let us build the future

…..together


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

Documents

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