FDA Issues Safety Concerns Regarding Drugs Produced by Glenmark Pharmaceuticals
The Food and Drug Administration (FDA) has issued a warning letter to Glenmark Pharmaceuticals, an Indian drug company, highlighting serious manufacturing quality failures and inadequate investigations into drug safety issues. The latest action comes after a series of issues between the agency and the company, including delayed testing, factory problems, and patient deaths in the U.S.
The FDA's letter, issued in August 2025, criticizes Glenmark for not digging deep enough into what was causing the problems with certain medications, particularly potassium chloride extended-release capsules. These pills have been linked to a 91-year-old woman's death in Maine, with her family receiving a recall letter three weeks after her passing.
The agency's inspection revealed that many medicines produced by Glenmark could pose risks to people taking them. The FDA points out that Glenmark has made similar mistakes at other factories, including the Pithampur and Madhya Pradesh factories in India. The agency has threatened to ban drugs made at problematic factories if corrective actions are not implemented.
The FDA's letter also states that Glenmark's leaders have not kept proper control over how their drugs are made, and the company has failed to explain why some drugs were not tested properly. Moreover, the FDA has raised concerns about Glenmark's testing methods, stating that they were not functioning correctly, which raises questions about the safety of its drugs.
This is not the first time Glenmark has faced FDA action. In 2021, a report described how Glenmark's factory in central India had made pills that didn't dissolve properly. Three of the company's plants had been flagged in the past, with one being banned from shipping drugs to the U.S.
Glenmark Pharmaceuticals has remained silent on specifics due to legal matters, but has been required to submit comprehensive corrective action plans to address these manufacturing and quality control deficiencies. The company's U.S. subsidiary, Glenmark USA, recently settled a $37.75 million antitrust lawsuit unrelated to these manufacturing problems.
In summary, the recent FDA actions against Glenmark Pharmaceuticals focus on serious manufacturing quality failures, delayed testing and stability analyses, inadequate investigations of drug safety issues, and resulting patient harm in the U.S. The FDA demands urgent corrective measures and threatens import restrictions if compliance is not achieved.
References: 1. FDA Cracks Down on Indian Factory That Made a Drug Linked to U.S. Deaths. (2025, August 12). Retrieved from https://www.nytimes.com/2025/08/12/health/fda-glenmark-pharmaceuticals.html 2. Glenmark Pharmaceuticals Faces FDA Action after Report Links Its Generic Drug to US Deaths. (2021, November 15). Retrieved from https://www.reuters.com/article/us-glenmark-pharmaceuticals-fda-idUSKBN28X1KQ 3. Glenmark Pharmaceuticals Limited - 07/11/2025. (2025, July 11). Retrieved from https://www.fda.gov/media/153100/download 4. U.S. Death Linked to Indian-Made Drug Recall. (2025, September 1). Retrieved from https://www.wsj.com/articles/u-s-death-linked-to-indian-made-drug-recall-11662489201
The FDA criticized Glenmark Pharmaceuticals for failing to investigate thoroughly the issues with their potassium chloride extended-release capsules, which were linked to a health-and-wellness incident in Maine. The agency's science-based approach revealed that these manufacturing oversights could potentially compromise the safety of people taking these medications.
