Drug firm Alkem Laboratories announced that the United States Food and Drug Administration (FDA) has issued an establishment inspection report (EIR) for its manufacturing facility at Baddi in Himachal Pradesh.
US FDA inspected Baddi facility from February 17 to 21, 2020, Alkem Laboratories said in a BSE filing.
The company said that the inspection has now been closed by the US FDA.
Alkem Laboratories is a multinational pharmaceutical company headquartered in Mumbai, Maharashtra that manufactures and sells pharmaceutical generics, formulations and neutraceutricals in India. Alkem has 21 manufacturing facilities: 19 in India and 2 in the US. The company had set up its research and development facility for ANDA development at Taloja in 2003.