Fibrinogen 1GM Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 1GM

Reference Brands:

Category: Blood Disorder

Human fibrinogen concentrate 1 g, a plasma-derived powder for intravenous use in bleeding linked to congenital fibrinogen deficiency. For haematology centres, hospital pharmacies, blood product importers and tender buyers.

Product Description:

Fibrinogen, clotting factor I, is the protein that thrombin converts into fibrin, the mesh that holds a clot together. Human fibrinogen concentrate is purified from pooled donor plasma and freeze-dried. This page covers 1 g vials of powder, reconstituted with water for injections and given by slow intravenous injection or infusion. Unlike cryoprecipitate or fresh frozen plasma, a concentrate delivers a known dose in a small volume, has been through viral inactivation steps, and needs no thawing or blood-group matching.

The established indication is bleeding, and cover for surgery, in congenital fibrinogen deficiency, either afibrinogenaemia or hypofibrinogenaemia. Some countries also license it for acquired deficiency during major surgical bleeding, so approved uses follow the local label. The dose is calculated from body weight and the measured plasma fibrinogen level, with monitoring towards a target range. The main risks are thrombosis and allergic reactions. As with every plasma product, a small residual infection risk remains, and haematology teams record batch numbers for traceability.

Sourcing notes. Fibrinogen concentrate is a prescription-only plasma-derived medicine. Regulators will want details of the plasma source, donor testing, viral safety steps and, in some regions, a plasma master file. Ask for the CTD dossier, a certificate of analysis for each batch showing fibrinogen content, the GMP certificate, a CoPP and the official batch release certificate where it applies. Storage differs between products, some refrigerated and others at room temperature, so plan transport to the label. Specify vial size, whether diluent and transfer device are included, and required shelf life.