Lupin Limited has received approval from the US Food and Drug Administration (USFDA) for its generic phytonadione injectable emulsion USP, used to treat and prevent blood-clotting disorders associated with vitamin K deficiency.
The approval covers the 1 mg/0.5 mL single-dose prefilled syringe formulation, which has been recognised as bioequivalent to the reference drug marketed by International Medication Systems Ltd.
According to IQVIA MAT data for August 2026, the product category had estimated annual sales of USD 52.3 million in the US. The approval strengthens Lupin's generic pharmaceutical portfolio and expands its presence in the US market.