Natco Pharma Ltd Receives EIR from U.S. FDA for API Unit at Mekaguda

Natco Pharma Ltd, a Hyderabad-based pharmaceutical company, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Active Pharmaceutical Ingredient (API) unit located in Mekaguda. The FDA had conducted an inspection at the facility from June 9 to June 13, 2025, and issued one observation classified as 'Voluntary Action Indicated' (VAI). The EIR has now been issued on July 24, 2025. Natco Pharma Limited is a leading oncology player in the targeted therapies of the domestic market and focuses on limited competition molecules in the US. The company has 9 manufacturing sites and 2 R&D facilities in India, approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO, and others, catering to 50+ global markets.