BusinessUS FDA Warns Emcure Pharma, Cites Repeated Data Fudging At Plant
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US FDA Warns Emcure Pharma, Cites Repeated Data Fudging At Plant
Emcure has 15 days to respond to the FDA's letter on the corrective actio
The US agency had already banned imports from the plant in July, except f
Bain Capital has a stake in unlisted Emcure
Mumbai: The US Food and Drug Administration (FDA) has warned Indian generic drugmaker Emcure Pharmaceuticals, saying it repeatedly fudged test records at its plant at Hinjwadi, Pune, in another case of a pharmaceutical firm in the country facing such action.
In a letter, the FDA said its staff inspected Emcure's Hinjwadi plant where the company makes injectable drugs, between January 27 and February 4 last year and found "significan...