Mumbai, Baltimore, November 02, 2023: Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Selexipag for Injection, 1800 mcg/vial, Single-Dose Vial, to market a generic equivalent of Uptravi® for Injection, 1800 mcg/vial, of Actelion Pharmaceuticals US, Inc. This product will be manufactured at Lupin’s Nagpur facility in India.
The product sales for Selexipag Franchise (RLD Uptravi®) in U.S. were USD 1,104 million for the year ended December 2022 and USD 978 million for the fiscal nine months ended October 1, 2023.
About Lupin Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
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For further information or queries please contact – Shweta Munjal Vice President & Global Head – Corporate Communications & Sustainability Email: shwetamunjal@lupin.com
*Safe Harbor Statement Uptravi® is the registered trademark of Actelion Pharmaceuticals Ltd
