Glenmark Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has completed an inspection of its formulation manufacturing facility in Chhatrapati Sambhaji Nagar (Aurangabad) with zero observations. The inspection, which took place from September 9 to September 20, 2024, resulted in the issuance of a Form 483 with no critical remarks, a positive outcome for the company.
This clean report from the U.S. FDA marks a significant achievement for Glenmark, ensuring continued compliance with stringent U.S. regulatory standards at its Aurangabad facility.
This is to inform you that the U.S. FDA has issued Form 483 with zero observations after an inspection at the Company’s formulation manufacturing facility based out of Chhatrapati Sambhaji Nagar (Aurangabad), India between September 09 and September 20, 2024, the company said in exchange filing
Glenmark shares closed 2.11% lower at ₹1,615.00 on the NSE.
