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Sun Pharma receives DMF approval for metaprolol tartrate

Our Bureau, MumbaiTuesday, February 18, 2003, 08:00 Hrs  [IST]

Sun Pharma's Ahmednagar site has received US FDA approval for its drug master file (DMF) to manufacture the antihypertensive bulk, metaprolol tartrate. The Ahmednagar site also holds a European certificate of suitability for this drug. These regulated market approvals would enable the company supply to large companies in North America and Europe. The 86,500 sq mt Ahmednagar site has been approved by several international manufacturers for sourcing bulk actives, and was recipient of the IDMA gold medal for quality excellence in bulk actives, the only gold award winner in its category this year. Sun Pharma is ranked 5th among all Indian pharma companies with a 2.92 per cent MS (ORG Retail Chemist Audit, Dec 2002). In niche therapy areas such as psychiatry, neurology, cardiology, gastroenterology, orthopedics, Sun Pharma ranks among the top three companies (CMARC July- Oct 02). Manufacturing for formulations and bulk actives is spread across 9 sites, one bulk site is USFDA approved. The company's R&D center SPARC, in Baroda is manned by 240+ scientists who work on process synthesis, dosage forms, NCE and NDDS with over Rs1200 mill invested so far (annual ~4 per cent turnover). The 40 person strong Bombay R&D center works on ANDA filings for the US generics market. A new research site spread over 16 acres with 200,000 sq ft research area is on schedule to become operational by mid 2003, this will have 150scientists on completion. A second R&D site is being built in Mumbai, in the Mahakali area, also expected to be commissioned by mid 2003. The outlay on innovation- based projects is expected to increase to 70% of the research budget by 2004.

 
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