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 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.

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.