The inspection at Glenmark’s Indore site was conducted between February 3 and February 14, 2025. Following the inspection, the FDA issued a warning letter highlighting concerns related to quality and compliance.
“We wish to inform you that the company has received a warning letter from the U.S. FDA for the company’s Indore, Madhya Pradesh (India) facility. The U.S. FDA had inspected Glenmark’s Indore site from February 3, 2025 to February 14, 2025,” the company said in an exchange filing.
However, Glenmark clarified that the warning letter is not expected to impact existing supplies or revenue from operations at the Indore site. The company stated, “The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.”
Addressing investor concerns, Glenmark emphasized its commitment to resolving the issues raised by the U.S. FDA at the earliest. It also clarified that there were no observations related to data integrity during the inspection.
“We uphold quality and compliance issues with utmost importance and remain committed to being compliant with CGMP quality standards across all our facilities,” the company noted.This update follows Glenmark’s earlier intimation on May 9, 2025, regarding the Indore facility receiving Official Action Indicated (OAI) status from the U.S. FDA.On Friday, shares of Glenmark Pharmaceuticals surged 14.5% to close at Rs 2,181.55 on BSE.
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