NATCO Pharma Limited has announced that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Active Pharmaceutical Ingredient (API) facility located in Mekaguda, Hyderabad. This follows a recent inspection that was carried out between June 9 and June 13, 2025.
During the inspection, the FDA issued one observation under Form 483, which was classified as “Voluntary Action Indicated” (VAI). This classification implies that the issues noted are not serious enough to warrant any regulatory or enforcement action, and NATCO can voluntarily correct them. With the EIR now issued on July 24, 2025, it signals the closure of the inspection process, which is generally a positive outcome for the company.
NATCO Pharma, based in Hyderabad, is known for its focus on research-driven, specialty and generic pharmaceuticals, including strong capabilities in oncology and targeted therapies in the domestic market. The company also has a strong presence in the U.S. market, particularly in limited-competition molecules.
In addition to pharmaceuticals, NATCO is active in crop protection products. The company operates nine manufacturing facilities and two R&D centers across India, with approvals from major global regulators such as the US FDA, Health Canada, ANVISA (Brazil), and the WHO. NATCO currently serves over 50 international markets.
