Dr Reddy’s gets USFDA extension for its response

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Published: November 27, 2015 12:47:55 AM

The US Food and Drug Administration (USFDA) has granted Dr Reddy's Laboratories extension till December 7 for submitting its responses to the regulator's warning letter. The company is in the process of preparing the responses.

The US Food and Drug Administration (USFDA) has granted Dr Reddy’s Laboratories extension till December 7 for submitting its responses to the regulator’s warning letter. The company is in the process of preparing the responses.

“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 company said in a statement.

On November 5, the regulator had issued a warning letter to the company on its active pharmaceutical ingredients (APIs) manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as an oncology formulation manufacturing facility at Duvvada, Visakhapatnam, AP. The USFDA had asked the company to respond within 15 working days of receipt of its letter of the specific steps that the company has taken to correct the situation, as well as how it plans to prevent repeating the deviations and violations cited. The USFDA was not satisfied despite Dr Reddy’s sending responses nine times from December 15, 2014 to September 15, 2015

Shares of Dr Reddy’s Laboratories came under heavy pressure on Thursday following the warning impact, and slumped 10% on reports that USFDA might withhold approval of the company’s fresh drugs and stop import if no corrective action is taken. The stock plunged nearly 10% to R3,049.75 in the intraday trading, closing at R3,110.35, a fall of 8.2% on the BSE.

The regulator said it had found several violations with regard to current good manufacturing practices (cGMP) at three of its plants. There were serious data integrity violations, including the backdating of records and failing to provide pertinent data to regulators.

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