U.S. FDA approvals for Indian pharmas jump 50%

Print 16 October 2015
Matthew Driskill / FiercePharmaAsia

Indian pharmaceutical firms got some good news last week when it was reported that during the period from July to September, there was a 50% gain in the number of abbreviated new drug approvals (ANDAs) from the U.S. FDA, Bloomberg TV India reported.

Bloomberg reported that companies like Lupin, Aurobindo Pharma, Cipla and Sun Pharma "received significant" FDA approvals, which in turn could prompt brokerages and ratings agencies to upgrade the producers.

Bloomberg reported that Indian drugmakers received 116 ANDAs during January-September 2015 as compared with 88 in the same period last year, a spike of 32%. The FDA has granted a total 468 ANDAs until September this year compared with 400 for all of 2014, the report added.

Officials at various companies in India said the rise in approvals was mostly because the FDA has moved to clear a backlog of cases and beefed up staffing levels at the government agency, the report said.

To be sure, Indian drug firms face massive problems meeting FDA manufacturing and quality standards, with a recent report by the Financial Timesnoting that at least 39 plants are now barred from exporting to the U.S. market.

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