US FDA issues import alert to Apotex’s Indian drug plant

The Food and Drug Administration (FDA) has issued an import alert to Apotex’s Bangalore site for the company’s drugs and antibiotics, with the exception of Riluzole tablets, which treat Lou Gehrig’s disease. The alert attributes the ban to the plant’s failure to meet manufacturing standards. The alert mentioned that Apotex's Riluzole tablets, a drug used to treat amyotrophic lateral sclerosis, or Lou Gehrig's disease, were excluded from the detention without physical examination action.

FDA inspected the plant in January and reported that the methods and controls used in its manufacture and control of pharmaceutical products do not appear to conform to current good manufacturing practices (cGMP).

Apotex Pharmachem is a global fully integrated API, R&D and manufacturing organization with its headquarters located in Brantford, Ontario, Canada and is a member of the Apotex group of companies. Apotex produces more than 300 generic pharmaceuticals. The company has multiple facilities around the world located in Canada, India, Mexico, and China. The company said that it was working closely with the FDA to resolve the problems.