Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.
The USFDA has approved Lupin’s Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited and is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency.
Phytonadione Injectable Emulsion had estimated annual sales of $52.3 million in the U.S. (IQVIA MAT Aug 2026).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
