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
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.
Factor IX Concentrate powder is available in Lyophilized (freeze-dried) powder
and strengths such as 250 IU, 500 IU, or 1000 IU per vial.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Factor IX Concentrate powder is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Factor IX Concentrate powder can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
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.
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