Awaiting USFDA response on remediation efforts of 3 units: DRL

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.