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News Topical, Digital Desk : The US FDA has sent a warning letter to Indian pharma company Glenmark regarding its manufacturing plant located in Pithampur (Madhya Pradesh). This plant was inspected between 3 February and 14 February 2025. After the investigation, the FDA has clearly stated that the manufacturing methods, resources and controls of this facility do not meet the rules of US CGMP (Current Good Manufacturing Practices). Glenmark's investigation on complaints of dissolution failure in Potassium Chloride ER capsules and another product was found to be incomplete and scientifically baseless.
Pressure on the stock- The company's stock opened at Rs 2,142.00 against the closing price of Rs 2,138.80. After this, as soon as the news and the stock fell half a percent to below Rs 2,125.
The company delayed stability testing, which led to late identification of product failure, late recall and field alert. The FDA also clarified in the letter that earlier GMP violations have also been found at Glenmark's Himachal Pradesh, Goa and North Carolina units: Himachal Pradesh Plant: Warning Letter in October 2019 Goa Facility: Warning Letter in November 2022 North Carolina Unit (US): Warning Letter in June 2023 i.e. many manufacturing centers of the company are constantly violating regulatory standards, which points to a serious lack of management monitoring and control. The FDA has asked Glenmark to appoint a CGMP expert consultant. The company should comprehensively review its Global Quality System. This step is necessary not only to correct the problems in Pithampur, but also to restore the quality of Glenmark's entire international operation.
What's next? The FDA warning has dealt a blow to Glenmark's regulatory credibility in the US. The company will now have to settle the matter and respond (CAPA) in the next few months, otherwise steps like a ban on supply or import alert in the US can be taken. For Glenmark, this warning letter is not just about one facility, but it is a sign of a widespread lapse in corporate governance and quality systems. GMP violations at four sites in three consecutive years can pose a big challenge to Glenmark's business - especially at a time when the demand for reliable suppliers in the US market is high.
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