USFDA extends time for Dr Reddy’s to respond on warning letters

Hyderabad, November 27, 2015: The US Food and Drug Administration (USFDA) has extended deadline for Dr Reddy’s laboratories Ltd to respond to its warning letters till December 7, 2015.

The Hyderabad-based Dr Reddy’s informed this to the Bombay Stock Exchange in an update on Thursday. “The company is in the process of preparing a response to the FDA’s warning letter,’’ it said.

On November 5, the US Regulator had issued a warning letter to the Hyderabad based company on its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as an Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, A P.

The time given for Dr Reddy’s to respond with corrective actions had expired originally on November 20, 2015 and it now remains to be seen how the issues are addressed as the deadline has been extended.

In the meanwhile, Dr Reddy’s scrip lost 8.22 per cent on the Bombay Stock Exchange on Thursday and is trading at Rs 3110.10 post lunch hour.-BusinessLine

Corporate Comm India(CCI Newswire)

The Pharma Times News Bureau

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