Natco Pharma gets EIR from USFDA for Hyderabad API facility
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.
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Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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