Prothrombin Complex Concentrate (Pcc) Injectable Concentrates Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 1,200 IU/vial
Reference Brands: NovoSeven, AryoSeven, BS-505(US)
Category:
Plasma Products
Recombinant Factor VIIa stimulates the extrinsic pathway of blood coagulation by activating factor X, promoting clot formation. It effectively controls bleeding in hemophilia with inhibitors and other bleeding disorders. Benefits include rapid bleeding cessation, reduced transfusion needs, and improved hemostasis during surgery or trauma, supporting patient safety and recovery.
Prothrombin Complex Concentrate (PCC) Injectable concentrates is available in Injection
and strengths such as 1,200 IU/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, Prothrombin Complex Concentrate (PCC) Injectable concentrates 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) |
Prothrombin Complex Concentrate (PCC) Injectable concentrates 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:
Recombinant Factor VIIa (e.g., NovoSeven) is approved in the US by the FDA and in the EU via EMA for controlling bleeding in hemophilia patients with inhibitors, and in other bleeding disorders. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing details, and pharmacovigilance plans. In the US, FDA review involves detailed assessment of clinical trial data, while the EMA ensures compliance with regional standards for quality and safety. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring thorough regulatory compliance is essential for the safe, effective, and timely worldwide approval of Factor VIIa products, supporting optimal patient outcomes.
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