Alembic Pharma gets USFDA nod for vitamin K deficiency treatment

Alembic Pharmaceuticals Limited announced on September 9, 2025, that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe. This approval allows Alembic to market a therapeutic equivalent to the reference listed drug product from International Medication Systems Limited.

The Phytonadione Injectable Emulsion is prescribed for treating hypoprothrombinemia caused by vitamin K deficiency or interference, as well as for the prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. The market for this specific prefilled syringe product is estimated to be $44 million for the twelve months ending June 2025, according to IQVIA data.

This latest approval increases Alembic's cumulative total to 225 ANDA approvals from the USFDA, comprising 204 final approvals and 21 tentative approvals. Alembic Pharmaceuticals, an India-headquartered research and development company, manufactures and markets generic pharmaceutical products globally. Its facilities are approved by various regulatory authorities, including the USFDA.