Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe

Alembic Pharmaceuticals Limited (Alembic) today announced that it 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 (International).

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. Refer label for a detailed indication.

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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 947.30 as compared to the previous close of Rs. 946.70. The total number of shares traded during the day was 2249 in over 320 trades.

The stock hit an intraday high of Rs. 956.65 and intraday low of 927.80. The net turnover during the day was Rs. 2130691.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval PhytonadioneInjectableEmulsion ANDA