By Dr. Kamal Kant Kohli,Ruchika Sharma
Copyright medicaldialogues
Hyderabad: Natco Pharma has announced that the U.S. Food and Drug Administration (USFDA) has issued Establishment Inspection Report (EIR) for the company’s Pharma division located in Kothur, Hyderabad, India, classifying the facility as Voluntary Action Indicated (VAI).”The unit has now received Establishment Inspection Report (EIR) classifying the facility as Voluntary Action Indicated (VAI),” the company,” Natco stated in a BSE filing.VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory actionThe inspection, carried out from June 9 to June 19, 2025, initially resulted in seven observations.Read also: USFDA inspection: Natco Pharma gets 7 observations for Kothur Pharma DivisionNATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven company in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company’s different manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.
