Glenmark Pharmaceuticals will be in focus on Monday, July 14, after the company disclosed that it has received a warning letter from the United States Food and Drug Administration (US FDA) for its Indore manufacturing facility in Madhya Pradesh.
The regulatory action follows an inspection conducted by the US FDA between February 3 and February 14, 2025.
In a statement, Glenmark clarified that the warning letter is not expected to impact current supplies or revenues generated from the Indore site. Importantly, the company confirmed that the US FDA’s observations did not involve 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.
Glenmark also reaffirmed its commitment to addressing the concerns raised by the regulator, noting it is working closely with the US FDA to resolve the issues at the earliest possible. The company emphasized its adherence to Current Good Manufacturing Practices (CGMP) and its focus on maintaining high quality and compliance standards across all operations.
This development comes after Glenmark had earlier informed on May 9, 2025, that the Indore facility was classified as “Official Action Indicated” (OAI) by the US FDA.
Investors and analysts will closely watch how the stock reacts today as the company works through the regulatory process and reassures the market about its supply chain and compliance measures.
