Mumbai, Sept. 9 -- The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, marketed by International Medication Systems.

Phytonadione Injectable Emulsion is used to treat hypoprothrombinaemia caused by vitamin K deficiency or interference. It is also indicated for the prophylaxis and treatment of vitamin K deficiency bleeding in neonates. For detailed indications, refer to the product label.

According to IQVIA, the estimated market size for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringes, is approximately US$44 million for the twelve months ending June 2025.

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