Glenmark Pharmaceuticals has informed that the Baddi unit of the company underwent an US FDA audit from November 6, 2017 to November 11, 2017. The USFDA issued seven observations through the form 483. The company is in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly on the observations. At this point in time, the company has informed that the Baddi unit contributes approximately 10 percent of the revenue of US sales.
The above information is a part of company’s filings submitted to BSE.
