Lupin receives tentative approval from U.S. FDA for Selexipag for Injection

Global pharma major Lupin Limited (Lupin) 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.

Shares of Lupin Limited was last trading in BSE at Rs. 1169.35 as compared to the previous close of Rs. 1132.55. The total number of shares traded during the day was 335339 in over 7023 trades.

The stock hit an intraday high of Rs. 1183.85 and intraday low of 1135.00. The net turnover during the day was Rs. 393509499.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 TentativeApproval USFDA Selexipag Injection