The US FDA has completed its inspection of Emcure’s manufacturing facility in Kadu, Gujarat, and has classified it as “No Action Indicated” (NAI). This signifies that the inspection revealed no significant regulatory violations, allowing Emcure to continue production and distribution without disruption. The initial inspection occurred on October 10, 2025, and this positive outcome underscores the company’s commitment to quality standards.
Positive US FDA Inspection Outcome
Emcure Pharmaceuticals has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) following an inspection of its manufacturing facility located in Kadu, Surendranagar, Gujarat.
Inspection Classification
The US FDA has classified the inspection of the facility as “No Action Indicated” (NAI). This classification indicates that the inspection did not reveal any significant regulatory issues requiring further action.
Details of the Inspection
The inspection, which took place on October 10, 2025, covered the manufacturing facility located at Survey No. 485 (New), 160/P1 (Old), Kadu, Taluka Lakhtar, Surendranagar – 382775, Gujarat. The successful outcome of the inspection reflects Emcure’s commitment to maintaining high standards of manufacturing and quality control.
Source: BSE
