FDA Warning for Dr Reddy's

November 10, 2015

November 10, 2015.

Reuters reports

that Dr Reddy's Laboratories Ltd, India's second-largest drugmaker, has received a warning letter from FDA over inadequate quality controls at three manufacturing plants producing drugs for cancer and other diseases. Dr Reddy's will not receive US approvals for drugs made at the plants until it the problems have been resolved.   The affected plants reportedly account for 10 percent to 12 percent of the company's sales. Dr Reddy's said a production halt may not be required, but they were "surprised" by the news, with shares dropping to a four-month low.   Dr Reddy's Chief Executive G V Prasad said the group was now revamping its quality systems.