USFDA issues warning letter to Glenmark Pharmaceuticals’ Monroe facility

22 Jun 2023 Evaluate

United States Food & Drug Administration (USFDA) has issued warning letter to Glenmark Pharmaceuticals’ Monroe, North Carolina (USA) facility. The Company had done a voluntary recall of all its products from this site in August 2021 and since then has not been commercializing any product from this site. Hence, the warning letter will have no impact on the existing revenues.   

The company continues to cooperate with the USFDA and is committed to undertake all necessary steps required to address their observations at the earliest. The Company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe. The USFDA had conducted the inspection at said facility between April 04 to May 19, 2022. 

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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