NATCO Pharma Limited announced conclusion of US FDA Inspection at our Manali, Chennai, Active Pharmaceutical Ingredients (API) Unit.

The U.S. Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Manali, Chennai, India, which was conducted from November 17th - November 21st, 2025.

On conclusion of the inspection, NATCO received seven observations in the Form-483. The company believes that the observations are procedural in nature. The company is confident to address these observations comprehensively.

NATCO remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally.