Major Recall: Indian Drugmakers Pull Products from US Market
Indian pharmaceutical giants Glenmark, Granules India, Sun Pharma, Zydus, and Unichem are voluntarily recalling products in the US due to various manufacturing issues, as reported by the US FDA. Recalls range from CGMP deviations and failed dissolution specifications to labeling errors, affecting a variety of drugs.
- Country:
- India
Major Indian pharmaceutical companies, including Glenmark, Granules India, Sun Pharma, Zydus, and Unichem, are pulling their products from the US market over manufacturing issues. This move comes as a result of regulatory findings by the US Food and Drug Administration (USFDA), which highlighted significant quality control problems.
Among the recalls, Glenmark's US-based unit is withdrawing Azelaic Acid Gel tubes from stores, citing complaints of gritty texture. Granules India is retracting more than 49,000 bottles of ADHD medication due to impurities, while Sun Pharma is recalling renal imaging kits over dissolution failures.
Zydus and Unichem are also part of the sweeping recalls targeting specific lots of antiviral drugs and mislabeled products, respectively. These actions demonstrate the commitment to safety and regulatory compliance, particularly given India's standing as a major pharmaceutical supplier with numerous USFDA-compliant facilities.
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