Natco Pharma Concludes USFDA Inspection at Chennai API Unit
Filing Summary
Natco Pharma Limited announced the conclusion of a U.S. Food and Drug Administration (FDA) inspection at its Active Pharmaceutical Ingredients (API) manufacturing plant in Manali, Chennai. The inspection, conducted from November 17 to November 21, 2025, resulted in seven observations noted in Form-483. Natco Pharma stated that these observations are procedural and expressed confidence in addressing them comprehensively. The company remains committed to maintaining cGMP compliance and supplying high-quality products globally. Natco Pharma is a prominent player in the pharmaceutical industry, focusing on generic and branded pharmaceuticals and specialty pharmaceuticals.
Natco Pharma Limited has announced the conclusion of an inspection by the U.S. Food and Drug Administration (FDA) at its Active Pharmaceutical Ingredients (API) manufacturing facility located in Manali, Chennai. The inspection took place from November 17 to November 21, 2025. Following the inspection, the company received seven observations documented in Form-483.
The company has indicated that the observations are procedural in nature. Natco Pharma has expressed confidence in its ability to address these observations comprehensively. The company has reiterated its commitment to being compliant with current Good Manufacturing Practices (cGMP) and to supplying high-quality products to its customers and patients worldwide.
Natco Pharma Limited, listed on both the BSE (Scrip Code: 524816) and NSE (Scrip Code: NATCOPHARM), is engaged in the development, manufacturing, and distribution of generic and branded pharmaceuticals, specialty pharmaceuticals, and active pharmaceutical ingredients. The company also produces crop protection products. Natco Pharma is recognized as a research and development-oriented and science-driven entity, with a significant presence in the oncology sector, particularly in targeted therapies within the domestic market. The company focuses on limited competition molecules in the United States market.
Natco Pharma’s manufacturing facilities have received approvals from several leading regulatory authorities, including the US FDA, Brazil ANVISA, Health Canada, and the World Health Organization (WHO), among others. These facilities cater to over 50 global markets.
For further information, Natco Pharma can be contacted through their investor relations email at investors@natcopharma.co.in or ir@natcopharma.co.in.
Natco Pharma Limited continues to prioritize research and development in its operations, focusing on oncology and limited competition molecules. The company aims to maintain its position as a leading player in the pharmaceutical industry by ensuring compliance with international regulatory standards and delivering quality products to its global clientele.