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 2025-09-09T11:30:38+05:30 | Updated On 9 Sept 2025 11:30 AM IST

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.

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 US$ 44 million for twelve months ending June 2025 according to IQVIA. Alembic has a cumulative total of 225 ANDA approvals (204 final approvals and 21 tentative approvals) from USFDA.

Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. The company is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic's brands, marketed through a field force of over 5500 are well recognized by doctors and patients.

alembic pharmaalembic pharma newsUSFDAphytonadione injectable emulsioninternational medication systemshypoprothrombinemiavitamin K

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751