Emcure Pharma gets USFDA EIR for Gujarat facility
Pune: Emcure Pharma has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Gujarat manufacturing facility located at Survey No. 485 (New), 160/P1 (Old), Kadu, Taluka - Lakhtar, Surendranagar - 382775, Gujarat.
The US FDA has classified the inspection of the facility as “No Action Indicated” (NAI).
NAI means no objectionable conditions or practices were found during the inspection.
The surveillance inspection was conducted from October 06, 2025 to October 10, 2025.
Established in 1981, Emcure Pharmaceuticals Ltd. is an Indian pharma company headquartered in Pune 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 designed to improve patient health and well-being across several major therapeutic areas. Emcure is present in 70+ countries globally including Europe and Canada.
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