Indian generic drugmakers getting more FDA approvals

Unperturbed by the regulatory pressure from the US Food and Drug administration, and a series of warning letters issued by the agency over the past few years, Indian generic filings have been rising.

India showed the largest gains in terms of perceived 'quality of API' and 'finished product' manufacturing, with Indian drug companies receiving 372 approvals to launch generic drugs in the USA in fiscal year 2019, 8.6% higher than last year. India had received 340 approvals last year.

The loss of patent exclusivity and cost cutting measures adopted by several nations has also hiked demand for generics.