Natco Pharma’s active pharmaceutical ingredients unit in Chennai has received seven observations from the U.S. Food and Drug Administration.

The U.S. FDA had conducted an inspection at the API manufacturing plant in Manali, Chennai, from November 17-21. On conclusion, of the inspection, the company received seven observations in the Form-483, the generic drugmaker said on Friday (November 21, 2025).

The company believes the observations are procedural in nature and is confident to address them comprehensively, Natco Pharma said, reaffirming commitment to being cGMP compliant and supplying high-quality products.