Antithrombin iii manufacturers

About antithrombin III

Antithrombin III manufacturers include plasma fractionators Grifols (Thrombate III), CSL Behring (Kybernin P) and Octapharma, plus recombinant producers in Japan. Antithrombin III is a natural blood protein that blocks clotting factors such as thrombin and factor Xa. Concentrates are used to treat and prevent blood clots in people with hereditary antithrombin deficiency, and in some countries for acquired deficiency. Pharmaceutical companies can source antithrombin III concentrates through supply, out-licensing or plasma fractionation partnerships.

Antithrombin III key facts

Antithrombin III manufacturers and licensing history

Antithrombin concentrates are made mainly from pooled human plasma. In the US, Grifols makes Thrombate III, which is now approved for adults and children with hereditary antithrombin deficiency. In Europe and other markets, CSL Behring sells Kybernin P and Octapharma sells Atenativ.

ATryn, a recombinant antithrombin produced in the milk of transgenic goats, was the first medicine from a transgenic animal to be approved. It has since been discontinued. In Japan, a recombinant antithrombin is also marketed.

Antithrombin III is a plasma-derived biologic, so production depends on plasma supply and fractionation capacity. Buyers should confirm the plasma source, viral inactivation steps, GMP status and cold-chain capability before choosing a supplier.

Antithrombin III dosage forms and dossier types

Antithrombin III is supplied as freeze-dried powder for intravenous infusion, labelled in international units (IU).

Antithrombin III regulatory and patent status

Plasma-derived antithrombin III has been approved for decades. In the US, Thrombate III is the main product, and its label now covers children. In the EU, products are authorised nationally, often for both hereditary and acquired deficiency. ATryn, the recombinant product, is discontinued. Plasma-derived antithrombin is off-patent, but manufacturing processes and recombinant technologies may be protected.

Antithrombin III mechanism of action and therapeutic use

Antithrombin III inactivates thrombin, factor Xa and other clotting factors, which prevents blood clots from forming. Heparin greatly speeds up this action, so people with antithrombin deficiency may not respond well to heparin. Concentrates restore antithrombin levels during high-risk periods, such as surgery, childbirth or acute thrombosis, in people with hereditary deficiency.

Antithrombin III licensing and sourcing

Antithrombin III suppliers and licensing partners typically offer finished-product supply, contract fractionation or dossier out-licensing. Buyers usually compare GMP status, plasma source, viral safety, cold-chain capability and territory availability. Current offers and supplier contacts are listed among the antithrombin III manufacturers on Pipelinepharma.

Frequently asked questions about antithrombin III

Who are the main antithrombin III manufacturers? Grifols makes Thrombate III, CSL Behring makes Kybernin P and Octapharma makes Atenativ. A recombinant antithrombin is also marketed in Japan.

What is antithrombin III used for? Antithrombin III is used to treat and prevent blood clots in people with hereditary antithrombin deficiency, especially during surgery or childbirth. In some countries, it is also used for acquired deficiency.

Is ATryn still available? No. ATryn, the recombinant antithrombin from transgenic goats, has been discontinued.

What forms and strengths of antithrombin III are available? Antithrombin III is available as freeze-dried powder for intravenous infusion, typically about 500 IU or 1,000 IU per vial.

Can antithrombin III be used in children? Yes. In the US, Thrombate III is approved for adults and children with hereditary antithrombin deficiency.