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.

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.