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US generics face competition from India

Indian companies have accounted for 35 per cent of all abbreviated new drug application approvals so far this year

Indian companies have accounted for 35 per cent of all abbreviated new drug application (ANDA) approvals so far this year, according to industry information portal, fiercepharma.com. Besides Ranbaxy, which is under Food and Drug Administration (FDA) investigation for falsifying data on its applications, all of the top Indian drugmakers have maintained or improved their approval rates. Sun Pharma received 30 ANDA approvals in 2008, up from 20 in 2007, and Wockhardt was awarded 18 in 2008, against 13 the previous year. Dr Reddy's obtained 14 approvals in 2008, from 13 in 2007. Meanwhile, Flamingo Pharmaceuticals has said it plans to introduce 20 new generics over the next six months, and is making improvements to its distribution network to facilitate its growth.

The rate of approvals is set to continue to increase following the FDA opening an office in Delhi in January. Seven FDA staff will be based in Delhi and three in Mumbai.

9th March 2009

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