The U.S. Food and Drug Administration has issued a warning letter to Glenmark Pharmaceuticals for the company’s manufacturing facility in Indore, Madhya Pradesh.
“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,” Glenmark said in a filing on Saturday.
The U.S. FDA had inspected the facility from February 3-14 and issued a Form 483 with five observations. In May, the company said it has received a communication from the regulator indicating the inspection classification as Official Action Indicated (OAI).
“We are committed to addressing the concerns raised… work with the U.S. FDA to resolve the 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…” Glenmark said.
Published – July 15, 2025 01:42 am IST
Source: https://www.thehindu.com/business/glenmark-gets-us-fda-warning-letter-for-indore-plant/article69811889.ece
