Financial Daily from THE HINDU group of publications
Tuesday, January 31, 2006
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Financial Daily from THE HINDU group of publications Tuesday, January 31, 2006 |
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News Update as at 18.00 hrs (IST)
Corporate MUMBAI: JB Chemicals & Pharmaceuticals Ltd on Tuesday said US FDA has accepted its Drug Master File (DMF) for Diclofenac Diethylamine which is used in topical formulation for pain management. DMF is filed electronically in the common technical document (CTD) version and is the first electronic USDMF filing from an Indian Active Pharmaceutical Ingredients manufacturer to the USFDA. "We are indeed pleased with this rapid filing which would allow us to strengthen our US market for Diclofenac API. We have proven regulatory expertise through electronic filings with US FDA and are leveraging this expertise," JB Chemicals Chairman and Ma naging Director J B Mody said. Diclofenac Diethylamine is non steroidal anti-inflammatory agent (NSAID) and used in topical formulation for pain management. -PTI
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