Ajanta Pharma Faces USFDA Scrutiny at Paithan Facility

Ajanta Pharma encountered regulatory challenges as the US Food and Drug Administration issued a Form-483 with five observations to its Paithan facility in Maharashtra. This development followed an inspection conducted from April 13 to 21, 2026.

This issuance of Form-483 indicates potential violations of the Food, Drug, and Cosmetic (FD&C) Act and associated regulations, as reported in the company's regulatory filing.

Ajanta Pharma stated their commitment to resolving the observations and will respond to the USFDA within the specified timeframe. The company underscores their dedication to compliance and corrective measures in response to these findings.

(With inputs from agencies.)