Apotex Withdraws 31 ANDAs Over Manufacturing Issues

July 16, 2019

The FDA has withdrawn 31 Apotex ANDAs at the company’s request.

The agency noted concerns about materials manufactured at two of the company’s facilities in India, Apotex Pharmachem India Private and Apotex Private Research.

Apotex Private Research received a warning letter from the FDA last year for inadequate out-of-specification investigations and for lacking valid in-process specifications. That same facility was hit with a warning letter at the end of 2015.

The withdrawn ANDAs include the blood pressure drug hydrochlorothiazide, the dementia treatment donepezil hydrochloride, and mycophenolic acid, which can help prevent organ rejection after transplants.

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