Glenmark: Manufacturing Flaws Trigger Glenmark, Sun Pharma, Zydus To Recall Several Medicines In US

(Photo : pixabay/Wikipedia) Glenmark, Sun Pharma, and Zydus have recalled several medicines from the US market. Indian pharmaceutical companies Glenmark, Sun Pharma, and Zydus have recalled several medicines from the US market due to manufacturing issues. Glenmark is recalling over 25 products, Sun Pharma is recalling around 13,700 bottles of Gabapentin capsules, and Zydus is recalling 3,144 bottles of Chlorpromazine Hydrochloride Tablets. The recalls have negatively impacted the shares of these companies, with Glenmark's shares falling over 13 percent in the last five sessions. The Indian government has increased spot inspections and sample testing of drugs in response to these recalls. Indian pharmaceutical powerhouses, Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus, have initiated a significant recall of several medicines from the US market. This recall is a response to manufacturing-related issues, as reported by the US Food and Drug Administration (FDA). Mumbai-based Glenmark Pharmaceuticals is recalling over 25 products from the US market due to deviations from current good manufacturing practices (CGMP). The US arm of the company, Glenmark Pharmaceuticals Inc., based in New Jersey, is pulling back several medicines, including Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets. Other recalled medicines include Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets, and Rufinamide Tablets. The company initiated this Class II recall on March 13, 2025. Recalls by Sun Pharma and Zydus Sun Pharmaceutical Industries is also recalling a product in the US. Its US-based unit, Sun Pharmaceutical Industries Inc., has recalled around 13,700 bottles of Gabapentin capsules. These capsules are used to treat and prevent seizures in people with epilepsy. The recall was initiated due to concerns of 'cross-contamination.' This Class III recall started on March 4, 2025. Zydus Pharmaceuticals (USA) Inc., a subsidiary of Zydus, is recalling 3,144 bottles of Chlorpromazine Hydrochloride Tablets. These tablets are used for treating mental health conditions such as schizophrenia and bipolar disorder. The USFDA said the recall was due to the presence of an impurity, N-Nitroso-Desmethyl Chlorpromazine, found above the acceptable limit. The company began this Class II recall on April 3, 2025. Impact on Indian Pharma Industry The shares of Glenmark have seen a strong downturn recently, falling over 13 percent in the last five sessions. This fall accompanies its peer stocks, as US President Donald Trump continues to threaten tariffs on pharmaceuticals. On Wednesday, Trump said his administration would soon announce a "major" tariff on pharmaceutical imports, aimed at encouraging drug manufacturers to shift operations back to the US. The products manufactured in India are shipped to over 200 countries around the globe, with Japan, Australia, West Europe, and the US as the main destinations. India has the highest number of USFDA compliant companies with plants outside of the USA. The government of India has taken the issue seriously and started random testing of the drug samples manufactured by companies from across the pharma sector. Since December 2022, the Central Drugs Standard Control Organisation (CDSCO), India's national regulatory body for cosmetics, pharmaceuticals, and medical devices, has increased the spot inspection of the pharma facilities to do sample testing.