Alembic Pharma Gets USFDA Approval for $44M Injectable Vitamin K Product

Alembic Pharmaceuticals has received USFDA approval for its Phytonadione Injectable Emulsion USP (1 mg/0.5 mL) in a single-dose prefilled syringe, a generic version of the drug used to treat vitamin K deficiency bleeding and hypoprothrombinemia. The product has a 12-month market size of $44 million (as of June 2025, per IQVIA), offering a significant revenue opportunity. The approval brings Alembic’s total USFDA ANDA count to 225, including 204 final and 21 tentative approvals, reinforcing its presence in the competitive U.S. generics market. A veteran pharma player since 1907, Alembic is a vertically integrated, R&D-driven company with global regulatory-compliant facilities. With this latest approval, it strengthens its portfolio of high-quality generics and enhances its potential for revenue growth in key international markets.