Glenmark Pharma gets seven observations from US FDA

The company’s Baddi unit contributes approximately 10 per cent of the revenue of the US sales

US FDA has made seven observations at Glenmark Pharmaceuticals’ Baddi manufacturing unit. According to the company, the 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 US FDA 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.