New Delhi: Alembic Pharmaceuticals Limited has announced that it has received final approval from the United States 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.
The approved product is therapeutically equivalent to the Reference Listed Drug (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, marketed by International Medication Systems Limited. Phytonadione, a synthetic form of vitamin K, is indicated for the treatment of hypoprothrombinemia caused by vitamin K deficiency or interference, and for the prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.
According to IQVIA data, the estimated market size for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, was approximately US$ 44 million for the twelve months ending June 2025.
This latest approval adds to Alembic’s growing portfolio of USFDA-approved products. The company now holds a cumulative total of 225 ANDA approvals, including 204 final approvals and 21 tentative approvals, reinforcing its position as a key player in the global generics market.
