Lupin gets US FDA nod for Phytonadione Injectable Emulsion

Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe. This approval signifies that Lupin's product is bioequivalent to the reference listed drug and is indicated for treating and preventing hypoprothrombinemia. The U.S. market for this product had estimated annual sales of USD 52.3 million as of August 2026. This approval is a significant step for Lupin in expanding its presence in the U.S. pharmaceutical market.