LUPIN : RECEIVES U.S. FDA APPROVAL FOR PHYTONADIONE INJECTABLE EMULSION

• U.S. FDA approves Lupin's ANDA for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe • Approved as bioequivalent to reference listed drug Phytonadione Injectable Emulsion of International Medication Systems, Limited • Product indicated for treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency • Phytonadione Injectable Emulsion had estimated annual U.S. sales of USD 52.3 million (IQVIA MAT Aug 2026) • Adds to Lupin's U.S. generics and complex generics portfolio; products distributed across over 100 markets

Lupin Ltd

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