USFDA alert for Wockhardt’s Third plant too


Bad news continues to plague Wockhardt with its bulk drug unit at Ankleshwar being issued an import alert from the US Food and Drug Administration on Friday due to poor manufacturing practices.The Ankleshwar unit manufactures active pharmaceutical ingredients (APIs) and was inspected last year by the US regulator.The import alert implies that products made at this facility cannot be exported to the US. This will negatively impact the company’s US business as its two other facilities at Waluj and Chikalthana are still under regulatory scanner.The Ankleshwar plant was earlier issued form 483, which notifies the company’s management about quality concerns at manufacturing plants.The USFDA banned exports from Wockhardt’s Waluj and Chikalthana plants in central India in 2013, citing manufacturing quality lapses. In November 2013, the USFDA had imposed restrictions on import of medicines produced at the company’s Chikalthana plant at Aurangabad in Maharashtra.

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