USFDA12 Jul 2025, 09:30 pm
Glenmark Pharmaceuticals Receives Warning Letter from US FDA for Indore Facility
AI Summary
Glenmark Pharmaceuticals Ltd. has received a warning letter from the U.S. FDA regarding its Indore, Madhya Pradesh (India) facility. The U.S. FDA conducted an inspection from 03 February 2025 to 14 February 2025. Despite the warning, the company believes there will be no disruption in supplies or impact on existing revenues from this facility. Glenmark is committed to resolving the concerns raised by the U.S. FDA and maintaining compliance with CGMP quality standards across all facilities. This update follows the previous communication on May 9, 2025, about the Indore facility receiving OAI status from the U.S. FDA.
Key Highlights
- Glenmark Pharmaceuticals Ltd. received a warning letter from the U.S. FDA for its Indore facility.
- The U.S. FDA inspected the Indore site from 03 February 2025 to 14 February 2025.
- Glenmark does not anticipate any disruption in supplies or impact on revenues from the Indore facility.
- The company is committed to addressing the U.S. FDA's concerns and maintaining CGMP quality standards.
- This announcement follows the previous communication about the Indore facility receiving OAI status from the U.S. FDA.