Rise in the number of USFDA approvals

The total number of Abbreviated New Drug Applications (ANDAs) from USFDA for Indian pharma firms rose to 129 this year, a rise of 45 per cent from the number of 89 for the period of January-July of 2015.

 

 

July 28, 2017: The companies which received the regulator’s approval for launching generic drugs and addressing their concerns are Cadilla Healthcare, Unichem Laboratories, Glenmark Pharmaceuticals, Divi’s Laboratories, Sun Pharmaceuticals, Dr Reddy’s. An ANDA has data which when submitted to USFDA does review and gives approval for a generic drug product.

 

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.

 

There are, however, several Indian facilities which are working to sort the FDA concerns including import alerts and warning letters issued to them.

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