Lupin shares in focus as USFDA approves two drugs for US market; here’s what investors should know

The pharma major received approval for releasing the tablets in multiple strengths of 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg in the United States, according to a regulatory filing dated April 8.

Furthermore, it 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,” it added.

In a separate filing dated April 7, the pharma major stated that it received approval from the US drug regulatory agency for its abbreviated new drug application for Dapagliflozin Tablets, 5 mg and 10 mg.

It has approved Lupin’s Dapagliflozin Tablets, 5 mg and 10 mg, as bioequivalent to Farxiga for the indications in the approved labelling.

On March 31, it had received approval for its abbreviated new drug application for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial.

“The U.S.FDA has tentatively approved Lupin’s Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vial as bioequivalent to Merck’s Bridion Injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery,” Lupin had said.

Lupin stock performance

Shares of Lupin closed 0.18% lower at ₹2,294.10 per unit on the National Stock Exchange (NSE) on Wednesday. However, the announcement was made after the market closed.

While the scrip has gained 1% in the past week, it has fallen 2%. On a year-to-date basis, it has advanced 9%.

The stock hit a 52-week high of ₹2,377.60 apiece on March 11, 2026, and a year’s low of ₹1,795.20 per equity share on March 11, 2025.

Lupin has a total market capitalisation of ₹1.05 lakh crore, as of April 8, 2026, according to data on the NSE.