Factor IX Concentrate powder bulk supplier for pharma manufacturers

Factor IX Concentrate Powder Suppliers & Bulk Manufacturers

Available Forms: Lyophilized (freeze-dried) powder

Available Strengths: 250 IU, 500 IU, or 1000 IU per vial

Reference Brands: BeneFIX (US/EU)

Factor IX concentrate, freeze-dried powder in 250, 500 and 1000 IU vials, plasma-derived or recombinant, for haemophilia B. For haemophilia centres, hospital pharmacies and tender buyers with 2-8°C cold chain.

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Product Description:

Factor IX concentrates replace the clotting factor missing in haemophilia B. There are three broad types: plasma-derived factor IX purified from donor plasma, recombinant factor IX made in cell lines, and extended half-life recombinant products in which factor IX is fused to an antibody Fc fragment or albumin so it lasts longer. Factor IX complex products, which also contain factors II and X, are a different class. All are freeze-dried powders reconstituted with the supplied diluent; this page lists 250, 500 and 1000 IU vials.

They are used to treat bleeds, to cover surgery and for regular prophylaxis. Doses are calculated in international units from body weight and the factor level needed, and recovery differs between products, so each patient's regimen is product-specific and any switch needs review by the haemophilia team. Inhibitors develop less often than in haemophilia A, but they can come with severe allergic reactions and, during immune tolerance treatment, nephrotic syndrome. Factor IX complex products carry a higher thrombosis risk.

Sourcing notes. Specify the product type, plasma-derived, recombinant or extended half-life, and do not accept factor IX complex in place of pure factor IX. Most products are stored at 2-8°C, and some labels allow a period at room temperature, so ask for temperature records and permitted excursions. For plasma-derived products request the plasma master file summary, donor screening and viral inactivation steps. Ask for the batch CoA, batch release certificate, GMP certificate and CoPP; many countries add national lot release. It is prescription-only. State total IU, vial sizes and diluent volume.

Factor IX Concentrate Powder — third party manufacturing & bulk supply

Factor IX Concentrate Powder is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Factor IX Concentrate Powder is supplied as Lyophilized (freeze-dried) powder — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Factor IX Concentrate Powder listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Factor IX Concentrate powder is used to treat and prevent bleeding episodes in patients with hemophilia B (also known as Christmas disease), a genetic disorder caused by a deficiency of clotting Factor IX. It is also used to control bleeding during surgery or after injury in affected patients.

Factor IX Concentrate powder is produced either from purified human plasma or through recombinant DNA technology. It contains coagulation Factor IX, a protein essential for the normal blood clotting process.

Common trade names include BeneFIX, Rixubis, Alprolix, Idelvion, and Mononine.

Factor IX Concentrate products are manufactured by several pharmaceutical companies including Pfizer, CSL Behring, Takeda, and Bioverativ/Sanofi depending on the specific brand.

The generic name is coagulation factor IX or coagulation factor IX (recombinant), depending on the formulation.

Brand names include BeneFIX (USA, EU, global markets), Rixubis (USA, EU), Alprolix (USA, EU, international markets), Idelvion (USA, EU, global markets), and Mononine (USA).

Factor IX Concentrate powder is manufactured in several countries including the United States, Germany, Switzerland, and other European countries depending on the manufacturer and product brand.