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FDA issues warning letters to API plants in China and India

7:04 AM MDT | June 18, 2014 | Deepti Ramesh

FDA issued separate warning letters earlier this month to the active pharmaceutical ingredient (API) manufacturing facilities of Tianjin Zhongan Pharmaceutical (Tianjin, China) and Apotex (Toronto) located at Tianjin; and Bangalore, India, respectively, for violating cGMP. The warning letters were published on the FDA Web site on 17 June. An FDA inspection from 27–31 January at the Apotex Bangalore facility identified that the manufacture of APIs significantly deviated from cGMP, FDA says. FDA issued an import alert against the Bangalore facility...

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