News

Lupin announced that it has received approval under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for its Abbreviated New Drug Application for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes. The U.S. FDA has approved Lupin`s Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes as bioequivalent to the reference listed drug (RLD) Valium� Injection 10 mg/2 mL (5 mg/mL) of Hoffman-LaRoche, Inc. and is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes had estimated annual sales of USD 77.9 million in the U.S. (IQVIA MAT May 2026).

Lupin announced that following approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application, the company launched Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vial in the United States. Lupin`s Sugammadex Injection is the bioequivalent to Bridion� Injection of Merck, Sharp & Dohme LLC (Merck) and is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery.

Lupin will hold a meeting of the Board of Directors of the Company on 6 August 2026.

Lupin announced the strategic spin-out of two oncology programs - LNP7457 (PRMT5) and LNP8701 (SOS1), through its wholly owned subsidiary, Lupin Inc., into Kaveri Therapeutics Inc. (Kaveri), a U.S. based clinical-stage oncology company. Kaveri will advance these programs through global clinical trials. Under the terms of the agreement, Lupin Inc. will have a significant equity stake in Kaveri, provide seed funding, and grant them exclusive rights to the programs. Kaveri will operate as an independent entity under the leadership of Chief Executive Officer Kristi Jones, a seasoned biopharmaceutical leader with a strong track record of building and advancing innovative companies, and Chief Medical Officer Dr. Robert Pierce, who brings deep clinical expertise and will lead the company`s clinical development strategy. Kaveri will seek to raise additional capital to fund its clinical development efforts. Notably, both programs have demonstrated encouraging clinical progress, with LNP7457 (PRMT5) and LNP8701 (SOS1) each reporting positive data at the American Society of Clinical Oncology (ASCO) meeting in 2025 and 2026, respectively.

Lupin announced that the 44th Annual General Meeting(AGM) of the company will be held on 4 August 2026.