Alembic Pharma gets USFDA nod for Phytonadione Injectable Emulsion for hypoprothrombinemia due to vitamin K deficiency
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-09-09 06:00 GMT | Update On 2025-09-09 06:00 GMT
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Vadodara: Alembic Pharmaceuticals Limited has announced that the company 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 Limited.
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