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“The company's formulation Srikakulam plant (SEZ) Unit I, Andhra Pradesh, have received an Establishment Inspection Report (EIR) from the US FDA,” Dr Reddy’s Laboratories said in BSE filing.
On June 16, 2017, the pharmaceutical company had said the USFDA issued a Form 483 with one observation on completion of audit of the above-referred facility.
Last week, Dr Reddy’s said that it had received EIR from the USFDA for a unit II of its Srikakulam plant in Andhra Pradesh. It, however, did not state if the US health regulator had made any observation in the EIR.
In a separate filing the company said it had received zero observations for its custom pharmaceutical services facility, technology development centre, at Miyapur in Hyderabad after audit of the facility by the USFDA.
In past one month, the stock has outperformed the market by surging 17% as compared to 2% decline in the S&P BSE Sensex.