Lupin receives U.S. FDA approval for generic vitamin K injectable emulsion

Lupin’s phytonadione injectable emulsion USP (1 mg/0.5 mL single-dose prefilled syringe) has received U.S. FDA approval and was determined to be bioequivalent to the reference drug from International Medication Systems Ltd. The product is used to treat and prevent hypoprothrombinemia and vitamin K deficiency. According to IQVIA MAT data for August 2026, its estimated annual U.S. sales are $52.3 million.