The United States Food & Drug Administration (USFDA) has inspected Glenmark Pharmaceuticals’ formulation manufacturing facility based out of Monroe, North Carolina, between April 04, 2022 and May 19, 2022. USFDA has issued Form 483 with 17 observations after an inspection at the Company’s formulation manufacturing in Monroe.
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. The Company will continue to work with the U.S. FDA 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.
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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