Indian Pharma gets 9% more USFDA approval

Indian Pharma

Indian Pharmaceutical companies have received 372 approvals to launch generic drugs in the US in FY19, 8.6 percent higher than that of last year.


India had received 340 approvals previous year.

The country’s pharma companies had got 15 warning letter in 2018, lower than that of US with 19 while China topped the list with 24 warning letters.

In the highly lucrative $60 billion plus generic market, Zydus Cadila topped the list with 60 approvals, with Indian company cornering nearly 40 percent share volume.


Unfazed by the regulatory pressure from the United States Food and Drug administration (USFDA), and a series of warning letters issued by them over the past few years, Indian generic filling have been rising. From 2015-17, the domestic pharma companies faced lot of heat from the USFDA, with major companies getting warning letters over manufacturing violations at their plants.

However, in 2018 India received fewer warning letters compared to the other nations.

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