India Pharma Outlook Team | Tuesday, 09 September 2025
Alembic Pharmaceuticals (Alembic) announced the receipt of final approval by the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe.
The newly authorized product has the same therapeutic effect as the listed reference drug (RLD), Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, by International Medication Systems. By this permit, Alembic consolidates its US market complex injectables line.
Phytonadione Injectable Emulsion is mainly used for hypoprothrombinemia therapy caused by vitamin K deficiency or consumption of drugs that inhibit vitamin K metabolism. At the same time, the drug is also used in the prevention and treatment of bleeding caused by vitamin K deficiency in newborn babies, a fatal condition with intervention as the only way to save lives.
Alembic took this opportunity to highlight that, as per IQVIA, the US market for a Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, was worth an estimate of US$ 44 million for the year ended June 2025.
On the subject of approval, the company expressed that this landmark event highlights their determination towards expanding the injectable segment of the business and simultaneously, maintaining access to top quality, reasonably priced medications in regulated markets.
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It is a frame of mind approval for Alembic that this particular approval adds to Alembic’s constant efforts to assure the R&D driven pipeline of specialty and injectable products, and in doing so, broadens its global footprint in the generic pharmaceutical landscape.
