40% Of All Generic New Drug Applications Approved By FDA In First Half Of 2013 Were Filed By Indian Companies

on August 29 2013 8:40 AM
Indian Generic Drugs
A Ranbaxy office building is pictured in the northern Indian city of Mohali May 14, 2013. Reuters

About 40 percent of all Abbreviated New Drug Approvals, or ANDA, issued by the U.S. Food and Drug Administration, or FDA, in the first half of the fiscal year have been secured by India-based pharmaceutical companies, a report by Centrum Broking showed.

ANDA is submitted to the FDA for its approval to manufacture and sell a generic drug, as an alternate for an existing licensed medication or an approved drug, in the U.S.

According to the Centrum report, Indian companies such as Sun Pharma (BOM: 524715) and Aurobindo Pharma (BOM: 524804) have received 20 and 21 ANDA approvals respectively. 

The FDA has approved 211 ANDAs and 47 tentative ANDAs between January 2013 and July 2013, and Indian companies and their subsidiaries have won 87 final ANDA approvals and 25 tentative approvals, according to Pharmabiz.com.

Among other Indian companies, Lupin (BOM:500257) received 11 approvals, Dr. Reddy's Laboratories (NYSE:RDY) received 7, Emcure Pharms received 6, while Claris Lifesciences (BOM:533288) and Glenmark (BOM:532296) won 4 approvals each.

During the last fiscal year ended December 2012, Indian pharma companies had won 178 ANDA approvals -- about 37 percent -- out of the total 476 approvals granted by the FDA. Last year, Aurobindo won the most number of approvals -- 24 ANDAs -- followed by Dr Reddy's Laboratories, which received 19 ANDAs.

India’s export-oriented pharmaceutical companies are expected to benefit from the steep depreciation of the rupee as a majority of their revenues come from U.S. markets, according to a report from The Economic Times.

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