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Dr. Reddy’s Laboratories to resolve issues raised by USFDA regarding cGMP norm violations

Dr. Reddy’s Laboratories had received a warning letter on November 5, 2015 from the USFDA regarding deviations from current good manufacturing practices (CGMP) at its active pharmaceutical ingredient (API) facilities at Srikakulam, Andhra Pradesh and Miryalaguda in Telangana.

The company has also received a warning letter for norm violations in its formulation facility at Duvvada in Visakhapatnam, Andhra Pradesh.

The company had already submitted its response to the warning letter on December 7, 2015 and said that the issues will be addressed in a timely manner. The company had already started the corrective action plans with respect to the warning letter and also started to enhance their quality management practices to meet USFDA expectations.



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