Dr.Reddy’s on Tuesday said the company has received Establishment Inspection Report (EIR) from US FDA for its active pharmaceutical plant (API) at Miryalaguda indicating the successful closure of the agency’s audit.
“We would now like to inform you that we have received an Establishment Inspection Report (EIR) from US FDA today as closure of audit,” the company said in a statement.
The plant was inspected by USFDA from February 13-21 got three Form 483 Observations from US FDA.
Miryalaguda plant called at CTO Unit V was one among the three plants for which the company received US drug regulator warning letter in November 2015.
The company didn’t mention whether the warning letter on the plant is lifted or not.
The warning letter mentioned deviations in good manufacturing practices such as failure to adequately investigate out-of-specification results and implement appropriate corrective actions; failure to maintain all quality-related documents appropriately; failure to prevent un-authorised access or changes to data and failure to identify storage containers for intermediates in batch production records.
Miryalaguda plant supplies active ingredients for company’s captive consumption as well as for its customers.
Moneycontrol in March reported that the observations pertaining to Miryalaguda were minor in nature.
To be sure Dr.Reddy’s management has already indicated that it got one product approval filed from Miryalaguda facility in the earnings call.
The announcement came after market hours.
The EIR still comes as a major reprieve for the company that was battling regulatory woes for last two years.
However still two of its plants including the Srikakulam API plant called CTO-6 and Duvvada oncology and harmonal injectable facility in Andhra Pradesh are still US FDA scanner.
Share of Dr.Reddy’s rose slightly by 0.08 percent to close at Rs.2628.10 on BSE, the benchmark Sensex gained 0.03 percent to end at 31,103.49 points.
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