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|Company Name||Centaur Pharmaceuticals Private Limited|
|Contact Person||Mr. S.D. Sawant|
|Address||Mr. S. D. Sawant
Address: Centaur House, Near Hotel Grand Hyatt, Vakola, Santacruz East, Mumbai, India
Zip/Postal Code: 400 055
Telephone No.: +91-22-66499100
Fax Nos.: +91-22-66499108/112
Web: www.centaurpharma.com ; www.lifesan.in
Mumbai, Maharashtra, India.
|Zip / Postal Code||400 055|
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Centaur Pharmaceuticals (API Division- formerly known as Centaur Chemicals) is India’s largest manufacturer and exporter of Active Pharmaceutical Ingredients with specialization in Psychotropic APIs since 1988 based on intellectual strength and core competence, having its focus on Contract Research, Process development, Contract manufacturing of Intermediates and APIs. From the API Portfolio around 28 products have been introduced for the first time in Indian market by Centaur. Centaur Pharmaceuticals (API division) has presence in more than 80 countries from North, South & Central America, East & Western Europe, West & South Africa, Middle-East and Asian countries.
The API manufacturing facility is situated at Ambernath, south of Mumbai 60 kilometers away. This facility has been accredited with ISO-9001-2008, ISO 14001:2004 & OHSAS 18001:2007, WHO-GMP (COPP) certifications. API facility has been inspected by AFSSAPS, the French health products safety agency and issued “Certificate of GMP compliance of a manufacturer” as per principles of Good Manufacturing Practice (GMP) for active substance (EU GMP Part II). The API facility also been audited by US FDA and approved the GMP Compliance in October 2008. Centaur holds Certificate of Suitability (CoS) for nine products issued by EDQM with 5 more applications are under review. Centaur also been issued with Accreditation Certificate by PMDA, Japan.
Centaur group also has three manufacturing facilities in the name of Centaur Pharmaceuticals for final formulated drug products such as solid dosage forms (tablets & capsules), liquids, oral suspensions, ointments and sterile ophthalmic drops. The products are exported to over 25 countries. One of three plants constructed to conforming to EU, TGA, MCC, MHRA and US FDA norms has been commissioned in the year 2008 for the production of solid dosage forms at Pune 140 km away from Mumbai. This plant has been inspected and approved by MHRA for oral solid dosage forms during February 2010. This plant also been approved by TGA Australia in April 2010. Ophthalmic section is under construction and expected to be operational by the end of 2011.
Centaur Pharmaceuticals has Research & Development sections for Chemicals and APIs and also for formulation development. These sections have been provided with analytical development sections with all modern instruments that are inclusive of NMR, XRPD, LC-MS, TGA, DSC etc. This R & D facility has been approved by the Department of Science and Technology (DST), Government of India.
LifeSan Clinical Research, a part of Centaur group is a CRO leveraging pilot & pivotal services to the pharmaceutical and generic-drug industries. This facility has been accredited by the Drug Controller General of India. LifeSan with its state-of-the-art set-up offers bioequivalence / bioavailability services for ANDA/NDA filings. Moreover, LifeSan renders comprehensive project planning and management for Phase II, III and IV clinical trials, including dossiers preparation to the respective regulatory authority. As a Centaur Group Company, LifeSan has access to a global network of resources for bioequivalence / bioavailability, Phase II-IV and clinical data management and regulatory affairs.
Centaur Pharmaceuticals (API Division) has the following services to offer, over and above the APIs that are manufactured and supplied:
1. Contract Research.
2. Custom Synthesis.
3. Process development.
4. Contract manufacturing of Intermediates and APIs.
5. Drug Master File preparation.
Services offered on formulation side are:
1. Formulation development.
2. Contract manufacturing of dosage forms.
4. Dossier preparation.
|Last Updated: 2010-12-20 18:07:10|
|Bulk Drugs / Intermediates of Centaur Pharmaceuticals Private Limited|