Will resolve issues raised by USFDA in a timely manner: Dr Reddy's
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.
DRL said it has provided an update to the USFDA on the progress of remediation in January 2016.
"Enhancing our quality management practices and meeting the USFDA expectations continues to be our highest priority," Dr Reddy's Laboratories Co-Chairman and CEO GV Prasad said.
The drug firm also said that the economic conditions in Venezuela continue to deteriorate further, increasing the risk of currency devaluation.
If the things do not improve in the Latin American nation, it can have a significant impact on the consolidated financial statements of the company, it said.
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.
DRL said it has provided an update to the USFDA on the progress of remediation in January 2016.
"Enhancing our quality management practices and meeting the USFDA expectations continues to be our highest priority," Dr Reddy's Laboratories Co-Chairman and CEO GV Prasad said.
The drug firm also said that the economic conditions in Venezuela continue to deteriorate further, increasing the risk of currency devaluation.
If the things do not improve in the Latin American nation, it can have a significant impact on the consolidated financial statements of the company, it said.
Next Story