Fibrinogen Concentrate Powder 1 g per vial Suppliers & Bulk Manufacturers
Available Forms: lyophilized (freeze-dried) powder
Available Strengths: 1 g per vial
Reference Brands: RiaSTAP (US & EU); Clottafact Fibrinogen, fibryga(EU), Fibrogen-L (India)
Category: Blood Disorder
Fibrinogen concentrate restores plasma fibrinogen levels by providing exogenous fibrinogen, essential for clot formation. It helps control bleeding, especially in congenital or acquired fibrinogen deficiencies. Benefits include rapid clot stabilization, reduced transfusion needs, and improved bleeding management, increasing patient safety during surgeries or trauma.
Product Description:
Fibrinogen concentrate is regulated in the EU and US as a prescription medical product. In the US, it is approved by the FDA, requiring a comprehensive dossier demonstrating safety, efficacy, and manufacturing quality. In the EU, it is regulated by EMA and authorized through CE marking. These regulatory frameworks ensure product quality and safety standards. For detailed regulatory insights and dossier requirements, visit PharmaTradz. Understanding compliance and registration processes is essential for manufacturers and healthcare providers seeking to supply fibrinogen concentrates in these markets. Reliable regulatory guidance helps ensure successful product approval and market entry.
Fibrinogen Concentrate Powder — third party manufacturing & bulk supply
Fibrinogen Concentrate Powder 1 g per vial 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 Fibrinogen 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 Fibrinogen Concentrate Powder →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Fibrinogen Concentrate powder is used to treat and control bleeding in patients with congenital or acquired fibrinogen deficiency. It helps restore normal blood clot formation during severe bleeding, trauma, or major surgery.
Fibrinogen Concentrate powder is made from purified human plasma and contains fibrinogen (coagulation factor I), an essential protein required for the final stage of the blood clotting process.
Common trade names include RiaSTAP, Fibryga, Haemocomplettan P, and FibCLOT.
Fibrinogen Concentrate products are manufactured by several pharmaceutical companies including CSL Behring, Octapharma, and LFB Biomedicaments.
The generic name is human fibrinogen or fibrinogen concentrate.
Brand names include RiaSTAP, Fibryga, Haemocomplettan P, and FibCLOT.
Fibrinogen Concentrate powder is manufactured in multiple countries depending on the manufacturer and production facility.
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