Lupin Receives U.S. FDA Approval for Phytonadione Injectable Emulsion
Lupin Limited received U.S. FDA approval for its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe. The product is indicated for treating and preventing hypoprothrombinemia and vitamin K-deficiency. The U.S. market for this product had estimated annual sales of USD 52.3 million.
FDA approval for a product with significant market sales has a moderate positive impact on the company's revenue and market position, though it is one product among many.
The approval from the U.S. FDA for a new product is a positive development for the company, indicating progress in its product pipeline and market expansion.
Lupin Limited announced on October 08, 2026, that it 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.
The U.S. FDA 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. This product is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency.
The estimated annual sales for Phytonadione Injectable Emulsion in the U.S. were USD 52.3 million (IQVIA MAT Aug 2026).
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