Glenmark Pharmaceuticals has received a warning letter from the U.S. Food and Drug Administration (USFDA) for the Company’s Indore, Madhya Pradesh (India) facility. The U.S. FDA had inspected the Glenmark’s Indore site from February 03, 2025 to February 14, 2025.
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. The company is committed to addressing the concerns raised by the USFDA and will work with the USFDA to resolve these issues at the earliest. There was no observation related to data integrity reported.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
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