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DRL says taking corrective actions after FDA warning letter


Hyderabad: Dr Reddy’s Laboratories on Monday said the US Food and Drug Administration has directed it to get a third party assessment of its three manufacturing plants for which it received warning letter last week.

Dr. Reddy’s CEO G V Prasad also said the company is in the process of shifting some of the products to other plants in the wake of warning letters.

“We have instituted corrective actions to assess the 483 observations received earlier for these sites. The recent letter underscores the need for us to reevaluate the work done in the light of the observations (made by the FDA) and continue to implement the process …

“The FDA wants us to focus on the issue (on the warning letter) and also get the third party verification and third party evaluation for certain things and also do it across our manufacturing network,” Prasad said in conference call.

The country’s second largest drug maker last week said it received a warning letter from the US drug regulator relating to two of its Active Pharma Ingredients (API) manufacturing plants and a Formulation plant located in Andhra Pradesh and Telangana.

DRL shares on Monday stumbled by 3.44 percent over previous close to Rs 3,504.60 on BSE.

The stock fell nearly 17 percent after the news of warning letters came to light.

The FDA issued a warning letter on November 5 relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh.

The warning letter followed the earlier inspections of these sites by the agency in November 2014, January 2015 and February 2015 respectively.


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