U.S. FDA warns Sun Pharma on manufacturing standards

Dec-19(Rakesh Thakur)

India’s largest drugmaker Sun Pharmaceutical Industries Ltd. said it had received a warning letter from the U.S. Food and Drug Administration for violating manufacturing standards at its Halol plant in western India. Sun Pharma said it had made “significant investments” in automation and training to improve quality systems at the plant, hired external consultants, and been updating the agency on the corrective measures it was taking. But the letter suggests the company is still months away from getting its plant cleared by the FDA and the FDA could ban all drug imports from the plant if Sun Pharma fails to fix issues there.

Share