Natco Pharma Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility located in Manali, Chennai. The inspection has been classified as Voluntary Action Indicated (VAI), according to a regulatory filing made by the company.
The USFDA conducted an inspection at the Chennai-based API division from November 17 to November 21, 2025. Following the inspection, the company had received seven observations in Form 483. With the issuance of the EIR and classification as VAI, the inspection process has now been formally closed by the US regulator.
A VAI classification indicates that while certain observations were noted during the inspection, the agency does not intend to take or recommend regulatory enforcement action at this stage. The company is expected to address the observations through appropriate corrective and preventive actions.
Headquartered in Hyderabad, Natco Pharma develops, manufactures and markets generic and branded pharmaceuticals, specialty medicines, active pharmaceutical ingredients and crop protection products. The company is known for its focus on oncology and targeted therapies in the domestic market and limited-competition molecules in the United States.
Natco Pharma operates nine manufacturing facilities and two research and development centres in India. Its manufacturing sites are approved by multiple global regulatory authorities, including the USFDA, Brazil’s ANVISA, Health Canada and the World Health Organization, and the company serves more than 50 international markets.