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Alembic Pharmaceuticals gets USFDA’s final approval for Phytonadione Injectable Emulsion USP
Sep-09-2025

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, of International Medication Systems (International). 

Phytonadione Injectable Emulsion is indicated for the treatment of hypoprothrombinemia due to vitamin K deficiency or interference. It is also indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, have an estimated market size of $44 million for twelve months ending June 2025 according to IQVIA. The company has a cumulative total of 225 ANDA approvals (204 final approvals and 21 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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