U.S. FDA approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL prefilled syringe

Lupin has received U.S. FDA approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe.

Thu 8 Oct 2026

Approved Product

Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe

Estimated Annual U.S. Sales

USD 52.3 million (IQVIA MAT Aug 2026)

Approval Basis

Bioequivalent to the reference listed drug of International Medication Systems, Limited

What happened

Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe.

What the product is

• Phytonadione Injectable Emulsion is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency.
• The U.S. FDA has approved Lupin's product as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited.
• The approved presentation is a single-dose prefilled syringe.

Market size mentioned in the release

• Estimated annual sales of Phytonadione Injectable Emulsion in the U.S. were USD 52.3 million (IQVIA MAT Aug 2026).
• This figure describes the size of the existing U.S. market for the product, not the revenue Lupin expects from it.

Why U.S. FDA approvals matter for a pharma company

• An approval allows the company to market and supply the product in the United States.
• Commercial outcomes depend on factors such as competition among suppliers, pricing and how the product is launched.

About the company, as stated in the release

• A global pharmaceutical company headquartered in Mumbai, with a presence across India, the U.S., Other Developed Markets and Emerging Markets, and products distributed in over 100 markets.
• Portfolio spans generics, complex generics, specialty medicines and biosimilars.
• 15 state-of-the-art manufacturing facilities, 6 research centers and a workforce of over 26,000 professionals.

The compliance angle

• The intimation was shared under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, enclosing the press release for information and dissemination.

What a retail investor can take away

• This is a product approval announcement accompanied by the company's own description of the U.S. market size for that product.
• The release sets out what the product is, what it was approved as equivalent to, and the market it addresses.

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