Factor Viii Concentrate Powder Suppliers & Bulk Manufacturers
Available Forms: Lyophilized (freeze-dried) powder
Available Strengths: 250 IU, 500 IU, 1000 IU, 2000 IU vials
Reference Brands: Hemofil M, Kogenate FS, Advate(US); Kogenate, Octanate, Lonoctocog alfa(EU)
Category:
Blood Disorder
Factor VIII concentrates are replacements for missing or defective clotting factor VIII in hemophilia A. They help restore normal blood clotting, reduce bleeding episodes, and prevent hemorrhages. Benefits include improved bleeding control, enhanced joint health, and increased quality of life for hemophilia patients, reducing bleeding-related complications.
Factor VIII Concentrate powder is available in Lyophilized (freeze-dried) powder
and strengths such as 250 IU, 500 IU, 1000 IU, 2000 IU vials.
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 VIII 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 VIII 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 VIII concentrates are approved in both the US and EU, supported by comprehensive dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA regulates these products, while the EMA oversees approval in the EU. Dossiers include clinical trial data, stability, and pharmacovigilance information. These concentrates are essential for hemophilia A management, used to prevent and treat bleeding episodes. Both regions require rigorous evaluation before market authorization. For detailed regulatory insights, licensing requirements, and approved dossiers for Factor VIII concentrates, visit Pharmatradz. Stay updated on global regulatory standards and market access pathways for hemophilia treatments.
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