The US Food and Drug Administration (USFDA) has issued a Warning Letter to Glenmark Pharmaceuticals for its Pithampur manufacturing facility, following an inspection conducted between February 3 and February 14, 2025.According to the letter, the facility’s methods, controls, and overall operations failed to comply with Current Good Manufacturing Practice (CGMP) regulations.
The agency flagged inadequate investigations into dissolution failures in potassium chloride extended-release capsules and another product, citing a lack of sufficient scientific justification in the company’s responses.
The FDA also raised concerns over delayed stability testing, which resulted in the late detection of product failures and subsequent delays in initiating recalls and issuing field alerts.
This isn’t Glenmark’s first run-in with the regulator. The FDA cited repeated CGMP violations across multiple sites, including:- A Warning Letter to its Himachal Pradesh plant in October 2019,
The agency flagged inadequate investigations into dissolution failures in potassium chloride extended-release capsules and another product, citing a lack of sufficient scientific justification in the company’s responses.
The FDA also raised concerns over delayed stability testing, which resulted in the late detection of product failures and subsequent delays in initiating recalls and issuing field alerts.
This isn’t Glenmark’s first run-in with the regulator. The FDA cited repeated CGMP violations across multiple sites, including:- A Warning Letter to its Himachal Pradesh plant in October 2019,
– One to its Goa facility in November 2022,
– And another to its North Carolina site in June 2023.
The recurring issues suggest systemic lapses in management oversight and quality control. The USFDA has recommended that Glenmark engage a qualified CGMP consultant and undertake a comprehensive review of its global quality systems.
Despite the development, shares of Glenmark Pharmaceuticals Ltd. were trading 0.48% higher on Thursday at ₹2,149. The stock has gained 33% so far in 2025.
