Fibrinogen Concentrate Powder Suppliers & Bulk Manufacturers
Available Forms: lyophilized (freeze-dried) powder
Available Strengths: 1 g per vial
Reference Brands: RiaSTAP (US & EU); Clottafact Fibrinogen, fibryga(EU)
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.
Fibrinogen Concentrate powder is available in lyophilized (freeze-dried) powder
and strengths such as 1 g 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, Fibrinogen 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) |
Fibrinogen 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:
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.
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