That’s right. Over the last several months, they accounted for 43 generic drug approvals, or 23 percent of the 186 ANDAs granted by the FDA. During the same period a year ago, Indian drugmakers received only 23 out of 139 final approvals, or 16.5 per cent.

The pace is accelerating, analysts say. Thirteen Indian firms received only 57 final approvals in the 11-month period between January and November 2006. During the same period in 2005, the FDA approved only 50 ANDAs of nine Indian companies. The rate reflects the growing number of patent expirations, including such blockbusters as Zocor, Zoloft and Ambien.

To illustrate the point, out of the 18 approvals given for generic Zoloft in February this year, seven Indian firms - Dr Reddy’s, Sun Pharma, Ranbaxy, Torrent, Lupin, Aurobindo and Zydus - won final approval.

“Globally, the trend is towards generic drug and this will augur well for Indian companies,” says R B Smarta, managing director of Interlink Marketing Consultancy. Says Pakhi Jain, a pharma analyst with Edelweiss Securities: “The approvals show bright prospects for Indian pharma firms in the US market…and in the future, Indian companies are likely to get a good share of the US generics market.”

So who received the largest number of approvals? The winner is Aurobindo Pharma with eight between December and April, followed by Wockhardt’s seven, six for Ranbaxy and five for Dr Reddy’s. Zydus Cadila received four final approvals, Sun Pharma and its US subsidiary Caraco got six approvals. The other companies include Lupin, Glenmark, Torrent and Unichem.

Source: The Business Standard

[tags]Aurobindo, Dr. Reddy’s, Generics, India, Ranbaxy[/tags]