Dr. Reddy’s Labs To Seek Reinspection Of Key Cancer Drug Facility By USFDA
Dr. Reddy’s will request the USFDA for a re-inspection for its Duvvada plant in 2018.
Dr. Reddy's Laboratories Ltd. plans to request a reinspection of its Duvvada unit in southern Andhra Pradesh by the U.S. drug regulator next year as the facility still can’t seek approval for new products under a warning letter issued earlier.
While the drugmaker received an Establishment Inspection Report (EIR) yesterday, it said the U.S. Food and Drug Administration hasn’t closed the inspection of the site and its status remains unchanged for the plant which makes two of key cancer drugs.
The EIR was "in order to be transparent about its regulatory process", the pharma company said in an exchange filing. The facility was under inspection between Feb 27 and March 8 this year.
In the cover letter to the EIR, FDA has explained that the inspection has not closed, and the site’s status remains unchanged.Dr. Reddy’s Exchange Filing
Dr. Reddy’s had received a warning letter from the USFDA in Nov. 2015. The U.S. regulator further made 13 observations for its Duvvada oncology formulation facility in March 2017. The plant contributes to less than 10 percent of its entire revenue but manufactures two key oncology drugs.
The stock rose as high as 10 percent before moderating its gains to a 2.1 percent rise to Rs 2,324 apiece.