Glenmark Pharma receives warning letter from USFDA for Indore facility

Glenmark Pharmaceuticals has announced that it received a warning letter from the U.S. Food and Drug Administration (FDA) for its manufacturing facility in Indore, Madhya Pradesh, India.

The USFDA inspection was conducted between 3 February and 14 February 2025.

In an official filing, the company stated that it does not anticipate the warning letter will disrupt supply chains or affect revenues generated from the Indore facility. Glenmark emphasized its commitment to addressing the FDA?s concerns promptly and working closely with the regulator to resolve the issues.

The company further clarified that there were no observations related to data integrity during the inspection. Glenmark reaffirmed its dedication to maintaining the highest quality and compliance standards, including adherence to Current Good Manufacturing Practices (CGMP), across all its facilities.

Glenmark Pharmaceuticals is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology.

On a consolidated basis, Glenmark Pharmaceuticals reported a net profit of Rs 4.65 crore in Q4 March 2025 as against a net loss of Rs 1,218.28 crore in Q4 March 2024. Net sales rose 6.77% year-on-year to Rs 3220.13 crore in Q4 March 2025.

The scrip shed 0.56% to Rs 2,169.30 on the BSE.

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