Caplin Point Laboratories Ltd on Wednesday, 23 April, announced that its subsidiary, Caplin Steriles, has secured approval from the United States Food and Drug Administration (USFDA) for its Phytonadione Injectable Emulsion USP, 10 mg/mL, which is used to treat Vitamin K deficiency. 

Caplin Steriles announced in an exchange filing that its latest product is a generic version of Hospira Inc.’s Reference Listed Drug (RLD) Vitamin K1 Injection.

The injectable, known as Phytonadione emulsion, is a synthetic form of naturally occurring vitamin K and is primarily used to address coagulation disorders caused by a deficiency or disruption in vitamin K activity. It plays a crucial role in correcting the impaired synthesis of blood clotting factors II, VII, IX, and X.

As per IQVIA (IMS Health), sales of this product in the U.S. reached around $18.5 million in the 12 months ending February 2025.

This approval from the USFDA marks another step forward in Caplin Steriles’ efforts to expand its presence in the U.S. generics market. To date, the company has submitted 47 Abbreviated New Drug Applications (ANDAs), with 35 already approved.

Caplin Steriles, recognized for its expertise in sterile manufacturing, holds approvals from key global regulators, including the US FDA, EU-GMP, ANVISA (Brazil), and INVIMA (Colombia).

Looking ahead, the company is actively developing a robust pipeline of more than 40 injectable and ophthalmic products, expected to be filed over the next four years.

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