Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) 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 $1,104 million for the year ended December 2022 and $978 million for the fiscal nine months ended October 1, 2023.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
