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Every announcement, straight from the exchange
Every Lupin regulatory approval announcement on NSE and BSE, newest first, each with its own page.
Time
12 announcements
Lupin Limited received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion, USP (1 mg/0.5 mL single-dose prefilled syringe).
Lupin Limited received tentative approval from the U.S. FDA for its Apixaban Oral Suspension 1.25mg/mL. The product will be manufactured at the company's New Jersey facility.
Lupin received U.S. FDA approval for Sodium Zirconium Cyclosilicate for Oral Suspension. The drug treats hyperkalemia in adults.
Lupin received tentative U.S. FDA approval for Enzalutamide Tablets. The approval covers strengths of 40mg, 80mg, 120mg, and 160mg.
Lupin received U.S. FDA approval for Ranluspec, an interchangeable biosimilar for Lucentis. This milestone expands the company's ophthalmology portfolio in the American market.
Lupin and Natco received U.S. FDA approval for Eribulin Mesylate Injection. The reference drug has estimated annual U.S. sales of ₹415.15 Crore.
Lupin received U.S. FDA approval for its Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride tablets. The product targets a USD 132.8 million market.
Lupin received Chinese regulatory approval for Oseltamivir Phosphate Oral Suspension, marking its first product entry into China. This milestone strengthens its global footprint in paediatric care.
Lupin received tentative U.S. FDA approval for Revefenacin Inhalation Solution, targeting a USD 260.7 million market. This strengthens Lupin's respiratory portfolio in the United States.
Lupin received US FDA approval for Famotidine Injection, targeting an $8.7 million market. This ₹82.65 Crore opportunity strengthens its presence in the US gastrointestinal segment.
Lupin Limited received U.S. FDA approval for Glycerol Phenylbutyrate Oral Liquid, a bioequivalent version of Ravicti. The reference product had annual U.S. sales of approximately ₹3201.50 Crore (USD 337 million) in 2025. The drug is indicated for chronic management of urea cycle disorders, strengthening Lupin's specialty generic portfolio in the U.S. market.
Lupin Limited received U.S. FDA approval for its generic Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, bioequivalent to Xigduo® XR. The company also secured tentative approval for a 2.5 mg/1,000 mg variant. This regulatory milestone enables Lupin to market the anti-diabetic medication in the United States, expanding its metabolic therapy portfolio.