2 days ago
Glenmark Pharma receives warning letter from US FDA for Indore facility
By Aman Shukla Published on July 12, 2025, 21:36 IST
Glenmark Pharmaceuticals has received a warning letter from the United States Food and Drug Administration (US FDA) concerning its manufacturing facility in Indore, Madhya Pradesh. The regulatory action follows an inspection conducted by the US FDA between February 3 and February 14, 2025.
The company clarified that the warning letter is not expected to impact the current supply chain or revenues generated from operations at the Indore site. Importantly, Glenmark stated that the US FDA observations did not include any data integrity issues.
'This warning letter will not affect the availability of our products in the market, and we remain focused on ensuring consistent supply without disruptions,' the company said in a statement.
Glenmark reaffirmed its commitment to addressing all the concerns raised by the US FDA and said it is actively working with the agency to resolve the issues at the earliest. The company emphasized its adherence to Current Good Manufacturing Practices (CGMP) and maintaining high standards of quality and compliance across all facilities.
This update follows Glenmark's earlier communication on May 9, 2025, regarding the Indore facility being classified as 'Official Action Indicated' (OAI) by the US FDA.
Ahmedabad Plane Crash
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
