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Alkem Labs gets EIR from USFDA for Baddi facility

Mar 13, 2020, 14:05 IST

PTI

New Delhi, Mar 13 () Drug firm Alkem Laboratories on Friday said the US health regulator has issued an establishment inspection report (EIR) for its manufacturing facility at Baddi in Himachal Pradesh.

The Baddi facility was inspected by the United States Food and Drug Administration (USFDA) from February 17 to 21, 2020, Alkem Laboratories said in a filing to BSE.

The USFDA has now issued an EIR for the manufacturing facility, it added.

On February 21, the company in a regulatory filing had said USFDA had issued a Form 483 with two observations at the end of the inspection of the facility.

It had said it shall put together a detailed response with adequate corrective and preventive measures to address the USFDA observations.

Shares of Alkem Laboratories were trading at Rs 2,468.40 per scrip on BSE, up 3.62 per cent from its previous close. AKT ANSANS

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