Warning letter from the U.S. FDA - Glenmark Pharmaceuticals Ltd

Code BSE: 532296 NSE:

Glenmark Pharmaceuticals Ltd 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 the Glenmark’s Indore site from 03 February 2025 to 14 February 2025. Glenmark Pharmaceuticals Ltd does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility. The concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest. There was no observation related to data integrity reported. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities.