Lupin Limited has informed the Exchange regarding a press release dated April 08, 2026, titled "Lupin Announces Approval of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in the United States ".
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Lupin Limited has received final approval from the U.S. FDA for its generic Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in four dosage strengths (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 the 2.5 mg/1,000 mg dosage. The product is bioequivalent to AstraZeneca's brand drug Xigduo® XR, which is used to treat type 2 diabetes. This approval allows Lupin to market this diabetes medication in the United States, expanding their US generic portfolio.
Positive for shareholders as FDA approval enables Lupin to launch this diabetes drug in the US market, potentially driving revenue from a chronic disease medication. However, the financial impact depends on market competition and pricing in the generic space.