Alkem Labs gets USFDA EIR for St Louis facility in US
New Delhi: Drug firm Alkem Laboratories on Tuesday said the US health regulator has issued an establishment inspection report (EIR) for its St Louis facility in the US.
The United States Food and Drug Administration (USFDA) has issued an EIR for the St Louis plant and the inspection has now been closed by the regulator, Alkem Laboratories said in a filing to the BSE.
The inspection was conducted by the USFDA from January 27, 2020, to February 6, 2020, it had said in an earlier filing.
At the end of the inspection, the company had received Form 483 with three observations and had said it shall submit to the USFDA within the stipulated timeline, a detailed response to close out all the observations associated with this inspection.
Shares of Alkem Laboratories were trading at Rs 2,576.60 per scrip on the BSE, down 0.88 per cent from the previous close.
Alkem Laboratories is a multinational pharmaceutical company headquartered in Mumbai.
The Company manufactures and sells pharmaceutical generics, formulations and neutraceutricals in India.