Glenmark Pharma gets 7 US FDA observations for Baddi unit, to reply soon

Glenmark Pharmaceuticals on Tuesday 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 per cent of the revenue of the US sales.

"The Baddi unit of Glenmark Pharmaceuticals underwent an 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.

The company's stock was trading 2.05 per cent down at Rs 579.10 apiece on the BSE in the morning trade on Tuesday.