Major Recalls Hit US Market: Aurobindo, Glenmark, Zydus Step Back Amid Manufacturing Hurdles

US health regulator reports recall of pharmaceutical products from Aurobindo Pharma, Glenmark, and Zydus due to manufacturing issues, including impurities and labeling errors. These actions underscore the importance of regulatory compliance for drug makers and highlight India's significant role in the global generic medicine supply chain.

In a significant move, pharmaceutical giants Aurobindo Pharma, Glenmark, and Zydus are withdrawing their products from the US market, citing manufacturing challenges as disclosed by the US Food and Drug Administration (USFDA).

Aurobindo Pharma USA Inc. is recalling over 100,000 bottles of Cinacalcet tablets due to the presence of an impurity exceeding FDA's interim limits. Initiated on November 7, the recall targets batches used for treating hyperparathyroidism.

Similarly, Glenmark Pharmaceuticals is retracting 90,000 bottles of Diltiazem Hydrochloride capsules, while Zydus Pharmaceuticals pulls 4,404 packs of Esomeprazole Magnesium over separate compliance issues. These instances highlight the critical importance of manufacturing precision for companies in the generic drug segment.

(With inputs from agencies.)