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Granules India Ltd has received an approval from the US Food and Drug Administration for its abbreviated new drug application for Naproxen Sodium. Naproxen Sodium, a non-steroidal anti-inflammatory drug, is used to reduce pain, fever and inflammation. It is sold under various brand names including Aleve and Midol in the US.
Commenting on the approval, Mr C. Krishna Prasad, Managing Director, Granules India said: “We are excited to offer Naproxen Sodium, which is used in more than six billion doses per year.”
The Hyderabad-based company was in discussions with several US generics drug manufacturers. The commercial orders for naproxen sodium finished dosages were expected to commence in the first half of 2012, he added.
Annual sales for branded naproxen sodium in the US exceeded $200 million for the 12 months ending March 31, 2011, according to SymphonyIRI Group.
Granules' scrip declined 1.90 per cent on the BSE to end at Rs 64.60 on Tuesday.
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