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USFDA issues seven observations to Glenmark Pharmaceuticals' Baddi unit

The United States Food & Drug Administration (USFDA) has issued seven observations to Glenmark Pharmaceuticals through form 483 for its Baddi unit. The USFDA had conducted audit at Baddi unit from November 6, 2017 to November 11, 2017.

The company is in the midst of providing a comprehensive response to the observations and would be replying to the USFDA shortly on the observations. Currently, the Baddi unit contributes approximately 10 percent of the revenue of US sales.

Glenmark's current portfolio consists of 129 products authorized for distribution in the US marketplace and 58 ANDA's pending approval with the USFDA.

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