The investments in R&D is yielding better results for the Indian pharmaceutical companies and their subsidiaries with higher approvals for ANDAs despite existing stringent approvals norms of US FDA. Indian companies managed to get 88 ANDA approvals from US FDA during the first half ended June 2012 which worked out to 41.1 per cent of the total approvals of 214 ANDAs. During first half of 2011, US FDA approved a total 238 ANDAs, out of which Indian companies received 88 final approvals.
Further, Indian pharma companies obtained 21 tentative approvals during January-June 2012 from US FDA as against 19 in the corresponding period of last year. The total tentative approvals were 49 during the first half of 2012 as compared to 50 in the last period.
Sun Pharma and its subsidiaries, including Taro Pharmaceuticals, received highest final ANDA approvals for 12 products during the first half of 2012. Aurobindo Pharma, Dr Reddy's Laboratories and Strides Arcolab got 9 final approvals each. During 2011, US FDA approved 431 ANDAs, out of which Indian companies grabbed 144 final approvals.
http://pharmabiz.com/NewsDetails.aspx?aid=69955&sid=1
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