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

Global pharma major Lupin Limited (Lupin) has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg to market a generic equivalent of Januvia Tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharp and Dohme Corp. (Merck). This product will be manufactured at Lupin's Pithampur facility in India.

Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Sitagliptin Tablets (RLD Januvia®) had estimated annual sales of USD 5789.3 million in the U.S. (IQVIA MAT October 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1245.65 as compared to the previous close of Rs. 1254.85. The total number of shares traded during the day was 16320 in over 989 trades.

The stock hit an intraday high of Rs. 1265.00 and intraday low of 1243.35. The net turnover during the day was Rs. 20458924.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 TentativeApproval USFDA ANDA SitagliptinTablets