Ipca Laboratories Addresses USFDA Concerns at Maharashtra Plant

The USFDA issued a Form 483 with three observations after inspecting Ipca Laboratories' API plant in Maharashtra. The company plans to respond promptly to these observations to address any potential violations under the FD&C Act. Ipca's shares saw a minor dip during mid-session trading post-announcement.

Ipca Laboratories announced on Friday that the United States Food and Drug Administration (USFDA) had issued a Form 483 with three observations following their inspection of the company's active pharmaceutical ingredient (API) manufacturing facility in Tarapur, Maharashtra.

The inspection, which took place from December 1-5, 2025, resulted in the USFDA highlighting conditions that may violate the Food, Drug, and Cosmetic Act and related laws. In response, Ipca committed to delivering a comprehensive reply within the stipulated timeframe and collaborating closely with the regulatory body to rectify the issues promptly.

Consequently, Ipca Laboratories' stock experienced a slight decline, trading at a 0.19% drop to Rs 1,454.35 per share on the Bombay Stock Exchange during the mid-session on Friday.