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Lupin Secures US FDA Approval for Vitamin K Injection
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CNBC TV18•08-10-2026, 23:36
Lupin Secures US FDA Approval for Vitamin K Injection
  • •Lupin Ltd has received US FDA approval for its Abbreviated New Drug Application for Phytonadione Injectable Emulsion USP in a single-dose prefilled syringe.
  • •The approved drug is bioequivalent to the reference listed drug marketed by International Medication Systems and is used to treat hypoprothrombinemia and vitamin K deficiency.
  • •Phytonadione Injectable Emulsion generated estimated annual sales of $52.3 million in the US according to recent market data.
  • •In a separate development, Lupin also recently gained US FDA approval for Sodium Zirconium Cyclosilicate for Oral Suspension used to treat hyperkalemia in adults.
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Key Questions Answered

Phytonadione Injectable Emulsion had estimated annual sales of $52.3 million in the US, according to IQVIA MAT August 2026 data.

The drug is used to treat and prevent low blood clotting caused by hypoprothrombinemia and vitamin K deficiency.

Lupin announced on August 10 that it had received US FDA approval for its ANDA for Sodium Zirconium Cyclosilicate for Oral Suspension.

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