Rise in the number of US FDA approvals of Indian ANDAs

The total number of Abbreviated New Drug Applications (ANDAs) from the US Food and Drug Administration for Indian pharma firms rose to 129 this year, an increase of 45% from the number of 89 for the period of January-July of 2015, according to a posting on the website of Brand India Pharma, an initiative led by Pharmexcil (Pharmaceutical Export Promotion Council) and IBEF (India Brand Equity Foundation) under the aegis of the Department of Commerce.

The companies which received the regulator’s approval for launching generic drugs and addressing their concerns are Cadila Healthcare, Unichem Laboratories, Glenmark Pharmaceuticals (BSE: 532296), Divi’s Laboratories, Sun Pharmaceuticals (BSE: 524715), Dr Reddy’s (BSE: 500124).

Though the FDA had raised several regulatory bans in the last three years, implicating import bans and suspension of new drug approvals, it is now granting approvals for new drugs for companies where the concerns were raised. The regulator has always insisted that companies upgrade their facilities as per their standards. The rise in the number of approvals also comes at a time when the US government is taking steps to cut down the cost of drugs.