Dr Reddy’s gets some relief as FDA extends deadline for reply

Dr Reddy’s gets some relief as FDA extends deadline for reply
Highlights

In a significant development, Dr Reddy\'s Laboratories Ltd was given more time to respond to the warning letter issued by the US Food and Drugs Administration (USFDA) with regard to quality control issues at three of its manufacturing plants located in Andhra Pradesh and Telangana.

It can now send responses to the warning letter from US regulator by December 7

Hyderabad: In a significant development, Dr Reddy's Laboratories Ltd was given more time to respond to the warning letter issued by the US Food and Drugs Administration (USFDA) with regard to quality control issues at three of its manufacturing plants located in Andhra Pradesh and Telangana. The health regulator issued warning letter to the drug major on November 5, directing it to send responses within 15 days. It now extended the deadline by two more weeks to December 7.

“The company is in the process of preparing a response to FDA's warning letter. The FDA has granted an extension until December 7, 2015 for the submission of the company's response to its warning letter,” the drug major said in a release.

In the warning letter issued on November 5, the USFDA said it found several violations with regard to current good manufacturing practices (CGMP). It asked Dr Reddy's for a third party assessment of comprehensive evaluation of the extent of inaccuracies in recorded and reported data. The letter also asked for a management strategy that includes global corrective action and preventive action.

The three plants that came under USFDA scanner include the company’s API manufacturing facilities at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, as well as oncology formulation manufacturing facility at Duvvada, Visakhapatnam in AP.

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