Indian drugmakers push into U.S. generics market

Indian drugmakers aren't deterred by the FDA's crackdown on India's largest generics maker, Ranbaxy. And they have good reason not to be. So far this year, Indian companies account for 35 percent of all abbreviated new drug application approvals. Besides Ranbaxy, which is under investigation for falsifying data [1]on its applications, all of the top Indian drugmakers have maintained or improved their approval rates this year.

Drug approvals given to Indian companies represented 26.5 percent of approvals granted in 2007, and 30 percent of approvals awarded in 2008, reports New Delhi's Rediff. After being hit with FDA investigations and an import ban on 30 drugs, Ranbaxy saw its approvals drop from 13 in 2007 to just 3 in 2008. But the company's problems appear to be isolated. In contrast, Sun Pharma received 30 ANDA approvals in 2008, up from 20 in 2007. Likewise, Wockhardt was awarded 18 in 2008, against 13 the previous year, and Dr. Reddy's was bumped up to 14 approvals in 2008, from 13 in 2007.

This trend is likely to continue, as the FDA opened its Delhi office in January. A total of 10 FDA staffers will be based in India, with seven in Delhi and three in Mumbai.

- read the Rediff article [2] for more

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Ranbaxy waves white flag at Feds [4]
Is the FDA persecuting India's generics makers? [5]
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$2.5B in outsourcing headed India's way [7]
Indian pharma gains on U.S. turmoil [8]