USFDA issues EIR for Emcure Pharma Pune API facility
Pune: In a recent BSE filing, Emcure Pharma has informed that the Company has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (“USFDA”) for the API manufacturing facility located at M.I.D.C., Kurkumbh, Taluka - Daund, Pune – 413802, Maharashtra. The USFDA has classified the inspection of the facility as “Voluntary Action Indicated” (VAI).
oluntary action indicated (VAI), means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
A current Good Manufacturing Practices (‘cGMP’) inspection was conducted from February 19, 2025 to February 25, 2025. Following the inspection, the company had initially received two observations in Form 483.
Read also: Emcure Pharma Pune facility gets 2 USFDA observations
Emcure Pharmaceuticals Ltd., established in 1981, is an Indian pharma company headquartered in Pune, India. It is engaged in developing, manufacturing and globally marketing a broad range of pharmaceutical products. Emcure is an R&D driven company that develops and manufactures a wide range of differentiated pharmaceutical products. Emcure is present in 70+ countries globally including Europe and Canada.
