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Lupin announces approval of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in the United States



Posted On : 2026-04-08 18:51:07( TIMEZONE : IST )

Lupin announces approval of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in the United States

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, 10 mg/1,000 mg. The company also received tentative approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 2.5 mg/1,000 mg.

The U.S. FDA has approved Lupin's Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets as bioequivalent to Xigduo® XR for the indications in the approved labeling.

Shares of Lupin Limited was last trading in BSE at Rs. 2293.55 as compared to the previous close of Rs. 2296.60. The total number of shares traded during the day was 53866 in over 3314 trades.

The stock hit an intraday high of Rs. 2334.95 and intraday low of 2257.00. The net turnover during the day was Rs. 122787750.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals USFDA Approval Dapagliflozin MetforminHydrochloride ExtendedReleaseTablets