FDA warns India’s Emcure Pharma, cites repeated data fudging at plant

The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring near WashingtonBy Zeba Siddiqui MUMBAI (Reuters) – The U.S. Food and Drug Administration (FDA) has warned Indian generic drugmaker Emcure Pharmaceuticals, saying it repeatedly fudged test records at its plant in western India, in another case of a pharmaceutical firm in the country facing such action. In a letter, the FDA said its staff inspected Emcure's plant at Hinjwadi, Pune, where the company makes injectable drugs, between January 27 and February 4 last year and found "significant violations" of standard manufacturing practices. The agency had already banned imports from the plant in July, except for some drugs, such as the cancer medicine carmustine, the antipsychotic haloperidol, and the antibiotic amikacin.



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