Global pharma major Lupin Limited (Lupin) on Thursday 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., the company announced through an exchange filing.
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.
Lupin Limited shares
The shares of Lupin Limited on Thursday at 12:50 pm IST were at Rs 1,177.75, up by 3.97 percent.
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.