Glenmark Pharmaceuticals to address USFDA’s observation

Glenmark Pharmaceuticals to address USFDA’s observation

By: IPP Bureau

Last updated : June 23, 2022 9:37 am



U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi


Glenmark Pharmaceuticals has informed that the U.S. FDA has issued Form 483 with six observations after an inspection at the Company’s formulation manufacturing facility based out of Baddi between June 13, 2022 and June 22, 2022.

The company is committed to undertake all necessary steps required to address their observations at the earliest. Glenmark Pharmaceuticals is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.

Glenmark Pharmaceuticals USFDA

First Published : June 23, 2022 12:00 am