FDC Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Fluconazole Tablets USP in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. This approval marks a significant step for the company in the U.S. market, potentially expanding its product portfolio and reach.

The ANDA approval indicates that the U.S. FDA has found the generic drug to be bioequivalent and therapeutically equivalent to the reference listed drug. This allows FDC Limited to market and sell these Fluconazole tablet formulations in the United States.

The company has officially intimated this development to the BSE Limited and the National Stock Exchange of India Ltd. on January 9, 2026, in compliance with Regulation 30 of the SEBI Listing Regulations.