Will resolve issues raised by USFDA in a timely manner: Dr Reddy's
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Hyderabad: Dr Reddy's Laboratories said it will resolve the issues raised by US Food and Drug Administration (USFDA) regarding norm violations at three of its manufacturing facilities "satisfactorily in a timely manner".
The city-based drug major 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 has submitted its response to the warning letter on December 7, 2015. The company believes that it can resolve the issues raised by the USFDA satisfactorily in a timely manner," Dr Reddy's Laboratories (DRL) said in a regulatory filing.
The company is concurrently continuing to develop and implement its corrective action plans relating to the warning letter, it added.
The city-based drug major 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 has submitted its response to the warning letter on December 7, 2015. The company believes that it can resolve the issues raised by the USFDA satisfactorily in a timely manner," Dr Reddy's Laboratories (DRL) said in a regulatory filing.
The company is concurrently continuing to develop and implement its corrective action plans relating to the warning letter, it added.
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