FDA May Refuse Entry, Deny Applications for Canadian Drug Company Apotex
The Food and Drug Administration found violations of Current Good Manufacturing Practice regulations at two of Canadian pharmaceutical manufacturer Apotex’s facilities, and may withhold approval of new drug applications and refuse admission as a result, said FDA in a warning…
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letter. “The evidence suggests that Apotex has failed to implement adequate global and sustainable corrective and preventive actions, and that it continues to manufacture and distribute pharmaceutical product without upholding its legal obligation to comply with CGMP,” FDA said.