Lupin Limited — Others, 04-02-2025: Rumour Verification - Regulation 30(11)

Lupin Limited has confirmed receiving tentative approval from the U.S. FDA for its generic formulation of Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets, marking it as the exclusive first-to-file. This product will be manufactured at the Nagpur facility in India.

This approval enhances Lupin's product portfolio, potentially boosting revenues and market presence in the U.S. pharmaceutical landscape. Investors may view this as a positive outlook, reflecting the company's regulatory achievements and growth potential in the competitive generic market.