Latest news with #LupinLimited
United News of India
2 days ago
- Business
- United News of India
Lupin gets tentative approval from U.S. FDA for Oxcarbazepine ER Tablets
Hyderabad, June 7 (UNI) Global pharma major Lupin Limited (Lupin) announced on Saturday that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Oxcarbazepine Extended-Release (ER) Tablets, 150 mg, 300 mg, and 600 mg. This product would be manufactured at Lupin's Nagpur facility in India, the Pharma company said in a release. Oxcarbazepine ER Tablets, 150 mg, 300 mg, and 600 mg are bioequivalent to Oxtellar XR® ER Tablets, 150 mg, 300 mg, and 600 mg, of Supernus Pharmaceuticals, Inc., and are indicated for the treatment of partial-onset seizures in patients 6 years of age and older. Oxcarbazepine ER Tablets (RLD Oxtellar XR®) had estimated annual sales of USD 206 million in the U.S. (IQVIA MAT April 2025). UNI KNR BM
Business Upturn
3 days ago
- Business
- Business Upturn
Lupin gets U.S. FDA tentative approval for Generic Oxcarbazepine ER Tablets
Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg strengths. These tablets are the generic equivalent of Oxtellar XR® ER Tablets by Supernus Pharmaceuticals and are indicated for the treatment of partial-onset seizures in patients aged 6 years and above. Lupin's version of the drug will be manufactured at its Nagpur facility in India. According to IQVIA MAT April 2025 data, Oxcarbazepine ER Tablets (RLD Oxtellar XR®) recorded estimated annual sales of USD 206 million in the United States, underscoring the potential market opportunity for Lupin. Headquartered in Mumbai, Lupin is a leading global pharmaceutical company with a strong footprint in the U.S. and India. The company focuses on a broad range of therapy areas including central nervous system disorders, respiratory, cardiovascular, anti-infective, and women's health. It operates 15 manufacturing sites and 7 research centers globally, supported by over 23,000 employees. Lupin continues to expand its U.S. portfolio of complex generics and remains committed to delivering high-quality, affordable medicines that improve health outcomes for patients around the world. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Yahoo
27-05-2025
- Business
- Yahoo
Lupin Announces Presentation of Phase 1 Data on LNP7457 (PRMT5 inhibitor) at the American Society of Clinical Oncology
MUMBAI, India, NAPLES, Fla. and CHICAGO, May 27, 2025 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) will present data from its Phase 1a clinical trial evaluating LNP7457, a PRMT5 inhibitor, at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois, from May 30 to June 3, 2025. The presentation titled 'A phase 1 dose escalation study of LNP7457 (PRMT5 inhibitor) in patients with advanced or metastatic solid tumors,' will be featured in the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology session. It can be viewed at Poster Board #422 on June 2, 2025, from 1.30 pm to 4.30 pm (CDT). Key findings from the study include: LNP7457 is generally safe and well tolerated in patients with advanced or metastatic solid tumors, with desirable PK/PD profile and no impact of food on the pharmacokinetics. The maximum tolerated dose, recommended phase 2 dose was determined based on safety, efficacy, PK/PD data, aligning with preclinical findings and the known safety profile of PRMT5 inhibitors. "We are delighted to share the initial results from Phase I study of our PRMT5 Inhibitor, a novel epigenetic onco-therapeutic targeted for monotherapy. We are committed to innovation and advancing cutting-edge science to offer meaningful therapeutic options for patients with difficult-to-treat cancers," said Vinita Gupta, CEO, Lupin. Current data from Lupin indicates that LNP7457 is unique within its field and appears to be safe and well-tolerated as a SAM-competitive PRMT5 inhibitor. Lupin will continue to study the efficacy of LNP7457 in its phase 1b trial in India and explore its potential for treatment of cancers with significant unmet medical needs. Details of the Presentation: Date and time: June 2, 2025, 1:30 pm – 4:30 pm (CDT) Location: Hall A - Posters and Exhibits | McCormick Place, Chicago, IL Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Sub Track: Small Molecules Clinical Trial Registration Number: CTRI/2023/07/054753 Doi: 10.1200/JCO.2025.43.16_suppl.3107 Abstract Number: 3107 Poster Board Number: 422 Abstract link: About Lupin Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit or follow us on LinkedIn Logo: View original content: SOURCE Lupin Limited Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
26-05-2025
- Business
- Business Upturn
Lupin and SteinCares sign license and supply agreement for Ranibizumab in Latin America
By Aman Shukla Published on May 26, 2025, 10:31 IST Lupin Limited has signed a license and supply agreement with SteinCares, a Latin America-based specialty healthcare company, for the commercialization of its biosimilar ranibizumab. The agreement covers all Latin American markets except Mexico and Argentina. Under the terms of the agreement, SteinCares will be responsible for regulatory filings, obtaining product registrations, and managing commercialization activities for ranibizumab across the specified LATAM region. Lupin will retain responsibility for manufacturing the biosimilar. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment. It targets and inhibits vascular endothelial growth factor A (VEGF-A), which plays a key role in the formation of abnormal blood vessels in the eye. The biosimilar is used in the treatment of several retinal disorders, including: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Myopic Choroidal Neovascularization (mCNV) The agreement aims to expand access to ophthalmology treatments in Latin America, leveraging SteinCares' regional presence and Lupin's biosimilar capabilities. Dr Cyrus Karkaria, President Biotechnology, Lupin stated, 'Our partnership with SteinCares underscores our commitment to providing innovative, high-quality healthcare solutions to patients in LATAM. Our intent is to transform the landscape of retinal care in Latin America, ensuring access to advanced therapies that improve the quality of life of patients.' Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Malaysian Reserve
20-05-2025
- Business
- Malaysian Reserve
Lupin and Honeywell Move Forward Jointly with Plans for HFO Technology in Inhalers
Lupin is set to become first Indian company to fully integrate Honeywell's Solstice® Air in its respiratory inhalers at scale, redefining respiratory care with near-zero global warming potential propellants Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: (BLOOMBERG: LPCIN) NEW DELHI and MUMBAI, India, May 20, 2025 /PRNewswire/ — Global pharma major Lupin Limited (Lupin) announced today its plan to use Honeywell's Solstice® Air (HFO-1234ze cGMP) propellant to transform respiratory care through the development of next-generation inhalers. Designed for patients with asthma and chronic obstructive pulmonary disease (COPD), Honeywell Solstice Air has the potential to prevent the release of high global warming potential (GWP) molecules, marking a major step forward in helping to reduce carbon emissions. Lupin intends to become the first pharmaceutical company in India to use Honeywell's Solstice Air product at scale as a next-generation propellant in pressurized metered-dose inhalers (pMDIs). Solstice Air offers an alternative to traditional hydrofluorocarbon (HFC)-based propellants, helping to reduce greenhouse gas emissions by up to 99.9%.1 By investigating the use of this innovative, non-flammable propellant in its pMDIs, Lupin is taking a significant step toward minimizing the environmental impact of respiratory solutions while providing effective treatment options for patients with asthma and COPD. 'Lupin's partnership with Honeywell underscores our commitment to delivering high-quality medicines while working towards a healthier, more sustainable future for our patients and communities worldwide. By integrating Solstice Air in our products, we are not only enhancing patient care, but we are also significantly reducing environmental impact,' said Vinita Gupta, CEO, Lupin. 'Solstice Air can play a critical role in ensuring that Lupin life-saving devices provide safe and effective treatment options that also leverage the latest advancements in technology to reduce harmful greenhouse gas emissions,' said Jeff Dormo, a president in Honeywell's Energy and Sustainability Solutions business. 'By continuing to research and develop advanced technologies for reducing carbon, Honeywell is dedicated to driving innovation that enhances the efficacy of health solutions while pioneering emissions reducing practices that support industry advancements.' The terms of the deal are subject to negotiation and execution of definitive documents acceptable to both Honeywell and Lupin. References: 1Studies conducted by UNEP and American Lung Association About Lupin Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit or follow us on LinkedIn About Honeywell Honeywell is an integrated operating company serving a broad range of industries and geographies around the world. Our business is aligned with three powerful megatrends – automation, the future of aviation and energy transition – underpinned by our Honeywell Accelerator operating system and Honeywell Forge IoT platform. As a trusted partner, we help organizations solve the world's toughest, most complex challenges, providing actionable solutions and innovations through our Aerospace Technologies, Industrial Automation, Building Automation and Energy and Sustainability Solutions business segments that help make the world smarter and safer as well as more secure and sustainable. For more news and information on Honeywell, please visit Solstice® is the registered trademark of Honeywell International Inc. Logo: View original content:
