U.S. FDA issues seven observations to Natco Pharma’s Chennai plant

Natco Pharma’s progressive pharmaceutical ingredients portion successful Chennai has received 7 observations from the U.S. Food and Drug Administration.

The U.S. FDA had conducted an inspection astatine the API manufacturing works successful Manali, Chennai, from November 17-21. On conclusion, of the inspection, the institution received 7 observations successful the Form-483, the generic drugmaker said connected Friday (November 21, 2025).

The institution believes the observations are procedural successful quality and is assured to code them comprehensively, Natco Pharma said, reaffirming committedness to being cGMP compliant and supplying high-quality products.