September 18, 2025

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Natco Pharma gets USFDA EIR for Kothur Pharma division

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). NATCO 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.

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