Awaiting USFDA response on remediation efforts of 3 units: Dr Reddys Laboratories
NEW DELHI: Dr Reddy's Laboratories (DRL) is awaiting a response from USFDA for future course of action over its three plants, for which the health regulator had issued warning letter, as the drug firm has completed its comprehensive corrective and preventive action plan (CAPA).
"As of January 31, 2016 all the CAPA which were due for completion have been completed," DRL's COO Abhijit Mukherjee told analysts.
He, however, did not share by when issues related to the three plants could be resolved saying, "on the remediation, we certainly cannot provide you any explanatory guidance on the timelines because on our side we are doing whatever we can to mitigate, workout on the CAPAs, update FDA and the overall journey, we think, is progressing satisfactorily. Beyond this (it) is completely the agency's prerogative."
The CAPA Plan includes site specific CAPA, manufacturing network-wide CAPA and CAPA to sustain and enhance quality and compliance performance on an ongoing basis, he added.
The USFDA in the warning letter issued to the company on November 5 last year had said it found several violations with regard to current good manufacturing practices (CGMP) in API manufacturing facilities at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, as well as in oncology formulation manufacturing facility at Duvvada, Visakhapatnam in AP.
In the warning letter the USFDA has said that DRL did not implement a robust quality system at its sites.
"Post receipt of the warning letter from USFDA in early November 2015 for three of our sites, we submitted on December 7, 2015 a Comprehensive Corrective and Preventive Action Plan, which in short is called 'CAPA' to address all the issues raised," Mukherjee said.
He further said: "We have submitted a status update to the warning letter response on January 28, 2016 stating our progress on accelerated remediation efforts towards sustainable compliance."
The company has also engaged third-party consultants, US-based Lachman consultants to provide necessary compliance and remediation support for assuring robust implementation and verification of the CAPA plan, he added.
"As of January 31, 2016 all the CAPA which were due for completion have been completed," DRL's COO Abhijit Mukherjee told analysts.
He, however, did not share by when issues related to the three plants could be resolved saying, "on the remediation, we certainly cannot provide you any explanatory guidance on the timelines because on our side we are doing whatever we can to mitigate, workout on the CAPAs, update FDA and the overall journey, we think, is progressing satisfactorily. Beyond this (it) is completely the agency's prerogative."
The CAPA Plan includes site specific CAPA, manufacturing network-wide CAPA and CAPA to sustain and enhance quality and compliance performance on an ongoing basis, he added.
The USFDA in the warning letter issued to the company on November 5 last year had said it found several violations with regard to current good manufacturing practices (CGMP) in API manufacturing facilities at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, as well as in oncology formulation manufacturing facility at Duvvada, Visakhapatnam in AP.
In the warning letter the USFDA has said that DRL did not implement a robust quality system at its sites.
"Post receipt of the warning letter from USFDA in early November 2015 for three of our sites, we submitted on December 7, 2015 a Comprehensive Corrective and Preventive Action Plan, which in short is called 'CAPA' to address all the issues raised," Mukherjee said.
He further said: "We have submitted a status update to the warning letter response on January 28, 2016 stating our progress on accelerated remediation efforts towards sustainable compliance."
The company has also engaged third-party consultants, US-based Lachman consultants to provide necessary compliance and remediation support for assuring robust implementation and verification of the CAPA plan, he added.
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