Alkem Labs gets inspection report from USFDA for Gujarat API facility

NEW DELHI: Drug firm Alkem Laboratories on Wednesday said it has received establishment inspection report (EIR) from the US health regulator on the closure of its inspection at its API facility at Ankaleshwar in Gujarat.

“The US FDA has issued an establishment an inspection report (EIR) for company's Active Pharmaceutical Ingredient (API) manufacturing facility located at Ankaleshwar, India which was inspected in December, 2016. The inspection has now been closed by the US FDA,” the company said in a filing to BSE.

Alkem Laboratories has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timeline. The USFDA has found the CAPA acceptable.