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.
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.
Factor Viii Concentrate Powder — third party manufacturing & bulk supply
Factor Viii 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 Viii 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 Viii 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 VIII Concentrate powder is used to treat and prevent bleeding episodes in patients with hemophilia A, a genetic bleeding disorder caused by a deficiency of clotting Factor VIII. It is also used to control bleeding during surgeries or injuries in patients with this condition.
Factor VIII Concentrate powder is produced either from purified human plasma or through recombinant DNA technology. It contains coagulation Factor VIII, a protein that plays a vital role in the blood clotting process.
Common trade names include Advate, Adynovate, Eloctate, Afstyla, Kovaltry, and NovoEight.
Factor VIII Concentrate products are manufactured by several pharmaceutical companies including Takeda, Bayer, CSL Behring, Novo Nordisk, Sanofi, and Pfizer depending on the specific brand.
The generic name is coagulation factor VIII or antihemophilic factor (recombinant).
Brand names include Advate (USA, EU, India, LATAM), Adynovate (USA, EU), Eloctate (USA, EU, global markets), Afstyla (USA, EU), Kovaltry (USA, EU, LATAM), and NovoEight (USA, EU, global markets).
Factor VIII Concentrate powder is manufactured in several countries including the United States, Germany, Denmark, Austria, and other European countries depending on the manufacturer and brand.
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