Glenmark Cited by FDA for Indian Plant

Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, has received a Form 483 with seven cited observations from the US Food and Drug administration (FDA) for its manufacturing facility in Baddi, India.

This follows an inspection by the FDA from November 6, 2017 to November 11, 2017. Glenmark says it is in the process of providing a response to the observations to the FDA.

The Baddi unit, which manufactures finished dosage-form products, contributes approximately 10% of the revenue of the company’s US sales, according to Glenmark.

Source: Glenmark Pharmaceuticals (Bombay Stock Exchange notice)


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