Lupin receives tentative approval from U.S. FDA for Dapagliflozin Tablets

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 Dapagliflozin Tablets, 5 mg, and 10 mg to market a generic equivalent of Farxiga® Tablets, 5 mg, and 10 mg of AstraZeneca AB. This product will be manufactured at Lupin's Pithampur facility in India.

Dapagliflozin Tablets (RLD Farxiga®) had estimated annual sales of USD 7282 million in the U.S. (IQVIA MAT September 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1198.05 as compared to the previous close of Rs. 1196.30. The total number of shares traded during the day was 132182 in over 3860 trades.

The stock hit an intraday high of Rs. 1216.05 and intraday low of 1192.65. The net turnover during the day was Rs. 158864261.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 TentativeApproval USFDA DapagliflozinTablets