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Glenmark Pharma gets 7 observations from USFDA for Baddi unit

Glenmark Pharma gets 7 observations from USFDA for Baddi unit

New Delhi: Glenmark Pharmaceuticals said the US health regulator has made seven observations after an audit at its Baddi manufacturing unit.

Glenmark said its Baddi unit contributes approximately 10 percent of the revenue of the US sales.

“The Baddi unit of Glenmark Pharmaceuticals underwent a US FDA (US Food and Drug Administration) audit from November 6 -11, 2017. The USFDA issued seven observations through the form 483,” Glenmark Pharmaceuticals said in a BSE filing.

“We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly on the observations,” it added.

The company, however, did not elaborate on the nature of observations.

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Source: PTI
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