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: Bebulin VH, Alprolix(LATAM), BeneFIX (USA),
Category: Blood Disorder
Factor IX concentrates are clotting factor replacements for hemophilia B. They restore the deficient factor, promoting blood clotting, and preventing bleeding episodes. Benefits include effective bleeding control, reduced hemorrhages, and improved quality of life, allowing patients to perform daily activities safely and decrease risks associated with spontaneous or trauma-induced bleeds.
Product Description:
Factor IX concentrates are approved in both the US and EU, supported by detailed dossiers demonstrating safety, efficacy, and manufacturing quality in accordance with GMP standards. In the US, the FDA oversees approval, while the EMA manages regulation in the EU. Dossiers include clinical trial data, stability, pharmacovigilance, and manufacturing processes. These products are essential for hemophilia B management, used to prevent and treat bleeding episodes. Both regions require rigorous evaluation before granting market authorization. For comprehensive regulatory insights, licensing procedures, and approved dossiers for Factor IX concentrates, visit Pharmatradz. Stay informed on the latest regulatory developments and global market access pathways for hemophilia therapies.
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:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required 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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Factor Ix Concentrate Powder →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
Related Products
Anagrelide Hydrochloride
Strength:
0.5 mg
Form: Capsules
Reference Brands: Agrylin (USA)
View Details
Ferric Maltol
Strength:
30 mg
Form: Capsules
Reference Brands: Accrufer (USA), Feraccru (EU)
View Details
Lusutrombopag
Strength:
3 mg
Form: Tablets
Reference Brands: Mulpleta (USA), Mulpleo (EU)
View Details
Quick Response Guaranteed | Verified Suppliers
