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The US Food and Drug Administration (USFDA) has not yet ‘closed’ its inspection of the formulations unit of Dr Reddy’s Laboratories Ltd located at Duvvada in Visakhapatnam.
In an update to the bourses on Tuesday, the Hyderabad-based Dr Reddy’s said the company had received the Establishment Inspection Report (EIR) for the facility from the US regulator.
The USFDA had issued a warning letter to the drug major on November 5, 2015, regarding the Duvvada unit.
“In the cover letter to the EIR, the FDA explained that the inspection has not closed and the site’s status remains unchanged, but the FDA has released the EIR in order to be transparent about its regulatory process,” the company said.
The company plans to request for a re-inspection of the facility in 2018 after further discussions on scheduling with the USFDA.
However, Dr Reddy’s shares gained 4.99 per cent on the Bombay Stock Exchange on Tuesday over the previous close and ended the day at ₹2,390.85.
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