Alkem Laboratories receives EIR from USFDA for Baddi facility

New Delhi: 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. 

Alkem Laboratories is a multinational pharmaceutical company situated in Mumbai, Maharashtra. The company was founded by Samprada Singh.

It sells and manufactures formulations, pharmaceutical generics and nutraceuticals in India.

Read also: Alkem Labs to acquire Dronabinol assets for Rs 71 crore from AbbVie

Alkem has 21 manufacturing facilities at multiple locations in India and the United States of America. The 2 facilities in the US were acquired in 2012 and 2013 respectively.

In 2014, Alkem acquired the "Clinic-A" brand in India from Galderma S.A. In 2015 ,again Alkem acquired a formulation manufacturing facility in the US.

Its upper-crest facilities are inspected and audited as per cGMP guidelines as laid down by leading regulatory authorities such as USFDA, MHRA - UK, SAHPRA-South Africa, TGA - Australia, ANVISA - Brazil, WHO - Geneva, TPD - Health Canada, PPB - Kenya, NDA - Uganda, MOH - Sudan, INVIMA - Colombia, TFDA - Tanzania, Zimbabwe, BfArM-Germany & Other Africa, Asian & CIS Countries.

Read also: Alkem Labs St Louis Facility Gets 3 USFDA Observations