LUPIN LTD.

Lupin Limited has announced a strategic collaboration with LABORATORIOS ERN S.A. (ERN) to launch Luforbec® (beclometasone/formoterol) pMDI in Spain. This fixed-dose combination is indicated for adult asthma and COPD treatment. The partnership leverages Lupin's respiratory expertise and manufacturing capabilities with ERN's established Spanish market presence. This move signifies Lupin's commitment to expanding access to quality respiratory care in Spain, following successful launches in the UK and Germany.

Lupin Limited has received approval from the U.S. Food and Drug Administration (FDA) for its ranibizumab injection, RanluspecTM (ranibizumab-hkdz). This marks Lupin's second U.S. biosimilar and is noted as the only interchangeable biosimilar ranibizumab approved in the U.S. available in both vials and pre-filled syringes. RanluspecTM is indicated for various eye conditions, including wet age-related macular degeneration and diabetic macular edema. The company views this approval as a significant step in expanding its biosimilars portfolio and enhancing patient access to affordable, high-quality vision therapies.

Lupin Limited and its alliance partner Natco Pharma Limited have received approval from the U.S. FDA for Natco's Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection. This injection is a bioequivalent to Halaven® Injection and is indicated for treating metastatic breast cancer and liposarcoma. The U.S. market for the reference drug had estimated annual sales of USD 43.7 million in April 2026. This approval marks a significant step for both companies in expanding their oncology product offerings in the U.S. market.

Lupin Ltd. has received approval from the U.S. FDA for its Abbreviated New Drug Application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g, bioequivalent to Sutab® Tablets of Azurity Pharmaceuticals, Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity. The product, indicated for colon cleansing, will be manufactured at Lupin’s Nagpur facility in India. The annual sale for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets (RLD Sutab®) was USD 132.8 million in the U.S. (IQVIA MAT March 2026).

Lupin Ltd announced that the acquisition of the minority shareholding in Multicare Pharmaceuticals Philippines, Inc., by its subsidiary Nanomi B.V., is now expected to be completed by July 2026. This is a delay from the previously anticipated completion date of end of May 2026, as indicated in their earlier intimation dated April 1, 2026. The completion is subject to certain closing conditions.

Lupin Limited announced that results from its Phase 1a trial evaluating LNP8701, a novel SOS1 inhibitor, have been accepted for publication at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting. The abstract details findings from an ongoing first-in-human study of LNP8701 in patients with metastatic solid tumors. Results indicate LNP8701 was well tolerated with desirable safety, pharmacokinetics profile, and favorable anti-tumor activity. Preliminary efficacy showed two patients completed 12 cycles and one patient completed 14 cycles with stable disease. Lupin will continue to study LNP8701's efficacy in its Phase 1b trial in India, exploring its potential as both monotherapy and combination therapy for solid tumors.

Global pharma major Lupin Limited announced it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Ankleshwar facility in Gujarat, India. This positive outcome follows the closure of a product-specific Pre-Approval Inspection conducted from March 2 to March 7, 2026. Nilesh Gupta, Managing Director, stated that this reflects Lupin's ongoing commitment to quality excellence and regulatory compliance, reinforcing its ability to deliver safe and effective medicines globally.

Lupin Ltd. has received approval from China's National Medical Products Administration for its Abbreviated New Drug Application for Oseltamivir Phosphate oral suspension, in partnership with Yabao Pharmaceuticals. This marks Lupin's entry into the Chinese market. The oral suspension, 6 mg/mL, will be launched and commercialized for treating influenza A and B in patients 2 weeks and older, and for prevention in individuals 1 year and older. Lupin aims to expand access to affordable medicines, particularly for pediatric use, through this partnership.

Lupin Ltd. has been included in the Dow Jones Best-in-Class (DJBIC) Indices for the first time, specifically the DJBIC World Index and the DJBIC Emerging Markets Index. This inclusion recognizes Lupin's commitment to sustainable, responsible, and ethical business practices. The DJBIC indices rank companies based on their ESG performance, using S&P Global CSA scores. Lupin previously achieved a score of 91/100 in the S&P Global CSA 2025, placing it in the top 1% globally.

Lupin Ltd. has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials. This product is bioequivalent to Mylan’s Yupelri® Inhalation Solution and is indicated for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). The estimated annual sales for Revefenacin Inhalation Solution (RLD Yupelri®) were USD 260.7 million in the U.S. (IQVIA MAT March 2026).