Lupin Ltd

Lupin as entered into an Exclusive Licensing Agreement with Valorum Biologics (Valorum), a biosimilar specialist in the U.S., for its biosimilar Armlupeg' (pegfilgrastim-unne). Under the terms of the agreement, Valorum will advance the commercialization and distribution of Armlupeg' (pegfilgrastim-unne) in the United States. Lupin will be responsible for manufacturing and supply of the product and will receive an upfront license fee and a royalty payment on net sales. Pegfilgrastim-unne is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy. Powered by Capital Market - Live

Under the terms of the agreement, Valorum will handle the commercialization and distribution of Armlupeg in the United States, while Lupin will be responsible for manufacturing and supplying the product. Lupin will receive an upfront license fee along with royalty payments on net sales. Armlupeg (pegfilgrastim-unne) is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients undergoing chemotherapy. 'We are pleased to collaborate with Valorum to expand access to affordable treatment options for patients undergoing chemotherapy. This partnership reflects our unwavering commitment to improving patient outcomes and aligns with our mission to make high-quality biosimilars more accessible. We look forward to strengthening our presence in the U.S. biosimilars market and building on our momentum as a global leader in developing and commercializing important biosimilar medicines,' said Spiro Gavaris, President ' U.S. Generics, Lupin. Par S. Hyare, CEO of Valorum, said, 'We are excited to launch Armlupeg (pegfilgrastim-unne) in the U.S. Our team has a proven track record in specialty markets, and we expect to capture significant market share through our commercial expertise. Crucially, we also look forward to providing another option for healthcare providers and patients, increasing access to this important treatment in oncology supportive care.' Valorum Biologics specializes in the U.S. commercialization of biosimilars, managing regulatory approval, product launch, and ongoing commercialization. The company focuses on optimizing patient access and delivering cost savings to the healthcare system. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin reported a 73.33% surge in consolidated net profit to Rs 1,477.92 crore in Q2 FY26 as against Rs 852.63 crore posted in Q2 FY25. Revenue from operations jumped 24.27% year-on-year to Rs 6,831.43 crore in the quarter ended 30 September 2025. The counter rose 0.47% to Rs 2,090.45 on the BSE. Powered by Capital Market - Live

Lupin announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg' (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta' (pegfilgrastim) 6 mg/0.6 mL injection. The product will be manufactured at Lupin's Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval. Armlupeg' is indicated for:  - Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  - Increase survival in patients acutely exposed to myelosuppressive doses of radiation. Powered by Capital Market - Live

Lupin Human Welfare and Research Foundation (LHWRF), the Corporate Social Responsibility (CSR) arm of global pharma major Lupin, has been awarded the CRISIL Voluntary Organisation grading of VO 1A, the highest classification, indicating 'Very Strong Delivery Capability and High Financial Proficiency.' This distinction is testament to LHWRF's dedication to excellence, transparency, and impact in the realm of social responsibility. For over 37 years, LHWRF has spearheaded initiatives to improve lives and livelihoods and strengthen healthcare for underserved populations across India. The Foundation remains dedicated to empowering communities and promoting holistic development. 'We are honored to receive the VO 1A rating from CRISIL, reflecting our commitment to social welfare and sustainable growth,' said Tushara Shankar, Head - CSR, Lupin. 'This recognition inspires us to expand our innovative programs that support communities and create lasting positive impact.' The CRISIL VO grading is a comprehensive assessment framework that evaluates an organization's overall ability to deliver on its goals. It focuses on factors such as stakeholder engagement, system and process efficiency, implementation and monitoring mechanisms, and financial management skills, including revenue and expenditure control, resource diversification, liquidity, and transparency reporting. Powered by Capital Market - Live

The inspection concluded with a Form-483, citing seven observations. Lupin stated that it will address the observations and respond to the FDA within the stipulated timeframe, and reaffirmed its commitment to comply with CGMP standards across all its facilities. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin reported 73.33% surge in consolidated net profit to Rs 1,477.92 crore in Q2 FY26 as against Rs 852.63 crore posted in Q2 FY25. Revenue from operations jumped 24.27% year-on-year to Rs 6,831.43 crore in the quarter ended 30 September 2025. Powered by Capital Market - Live

The inspection concluded with a Form-483, citing seven observations. Lupin stated that it will address the observations and respond to the FDA within the stipulated timeframe, and reaffirmed its commitment to comply with CGMP standards across all its facilities. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin reported 73.33% surge in consolidated net profit to Rs 1,477.92 crore in Q2 FY26 as against Rs 852.63 crore posted in Q2 FY25. Revenue from operations jumped 24.27% year-on-year to Rs 6,831.43 crore in the quarter ended 30 September 2025. Shares of Lupin shed 0.10% to end at Rs 2,028.70 on the BSE.Powered by Capital Market - Live

Lupin announced that the United States Food and Drug Administration (U.S. FDA) has completed a product specific Pre Approval Inspection at its Unit-1 oral solid dosage manufacturing facility in Nagpur. The inspection was carried out from 10 November to 14 November 2025, and concluded with zero 483 observations. Nilesh Gupta, Managing Director, Lupin said, 'The successful outcome of the U.S. FDA inspection at our Nagpur Unit-1 facility exemplifies our commitment to uphold and maintain the highest standards of quality, compliance, and safety across our facilities. We remain dedicated to improving the lives of our patients globally.'Powered by Capital Market - Live

The inspection, conducted between November 10 and 14, 2025, concluded with zero Form 483 observations, signalling full compliance with regulatory standards. Nilesh Gupta, MD, Lupin said, 'The successful outcome of the U.S. FDA inspection at our Nagpur Unit-1 facility exemplifies our commitment to uphold and maintain the highest standards of quality, compliance, and safety across our facilities. We remain dedicated to improving the lives of our patients globally.' Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin reported 73.33% surge in consolidated net profit to Rs 1,477.92 crore in Q2 FY26 as against Rs 852.63 crore posted in Q2 FY25. Revenue from operations jumped 24.27% year-on-year to Rs 6,831.43 crore in the quarter ended 30 September 2025. Shares of Lupin rose 0.11% to end at Rs 2,055.10 on the BSE. Powered by Capital Market - Live

Lupin today announced the launch of Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials, with 180-day CGT exclusivity in the U.S. This follows the recent approval received from the United States Food and Drug Administration (U.S. FDA). This is Lupin's first product using proprietary technology from PrecisionSphere', the long-acting injectable (LAI) platform developed by Lupin's subsidiary Nanomi B.V.'s (Nanomi). Nanomi's LAI platform has demonstrated efficacy and safety in drug delivery. Its proprietary PrecisionSphere' technology creates uniform microspheres that deliver extended-release profiles from weeks to months, superior injectability through smaller needles, and consistent drug concentrations. Lupin is expanding the reach of its PrecisionSphere' technology by fostering collaborations with companies looking to extend their product lifecycles. Powered by Capital Market - Live

Lupin Manufacturing Solutions (LMS), a wholly owned subsidiary of global pharma major Lupin, today announced the commissioning of its dedicated Oncology Block at its Vizag facility in India. The new high-containment unit significantly enhances LMS's end-to-end Contract Development and Manufacturing capabilities for High Potent Active Pharmaceutical Ingredients. It will support clients across the oncology development lifecycle from preclinical research to commercial manufacturing, addressing growing global demand for oncology drug development and manufacturing. Spanning 4,270 square meters, the new facility, is equipped with 20 reactors, ranging from 250L to 2000L, with over 20 isolators and advanced containment systems, ensuring exposure levels of ≤0.05 'g/m'. Designed with flexible scale-up capabilities (1'35 kg batch range) and comprehensive environmental controls (≤25'C, ≤45% RH), the facility allows for safe, efficient, and compliant production of oncology APIs that meet global quality standards.Powered by Capital Market - Live