Wockhardt’s Ankleshwar Plant Gets Import Alert From U.S. Health Regulator
U.S. FDA bans import of drugs from Wockhardt’s Ankleshwar plant.
In yet another blow to drug maker Wockhardt, the U.S. health regulator has banned import of products manufactured at its Ankleshwar plant for non-compliance of manufacturing norms.
The company’s Ankleshwar plant manufactures bulk drugs, the U.S. Food and Drug Administration (U.S. FDA) said in a notice on its website.
The import alert has been issued under ‘Import Alert 66-40’, which authorises the health regulator “detention without physical examination of drugs from firms which have not met drug GMPs”.
Already the company’s two plants at Chikalthana and Waluj have been banned from exporting drugs to the U.S. by the health regulator.
In November 2013, the U.S. FDA had imposed restrictions on import of medicines produced at the company’s Chikalthana plant at Aurangabad in Maharashtra.
Earlier in May, the U.S. FDA had also issued an import alert on the company’s Waluj facility which makes injectables and solid dosages.