Prothrombin Complex Concentrate (Pcc) Injection Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 250 IU to 300 IU
Reference Brands: Kcentra (4-factor PCC), Bebulin VH (3-factor PCC)(US)
Category:
Blood Disorder
Prothrombin Complex Concentrate (PCC) provides concentrated clotting factors II, VII, IX, and X, quickly restoring blood clotting. It effectively reverses anticoagulation effects, reduces bleeding, and stabilizes hemostasis in urgent settings. Benefits include rapid action, minimal volume, and improved patient outcomes during emergency bleeding or warfarin reversal.
Prothrombin Complex Concentrate (PCC) injection is available in Injection
and strengths such as 250 IU to 300 IU.
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) injection 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) injection 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:
Prothrombin Complex Concentrate (PCC), marketed as Kcentra in the US and various brands in the EU, is approved for urgent reversal of warfarin anticoagulation and uncontrolled bleeding. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed submissions, while the EMA ensures compliance with regional standards. Proper dossier preparation and adherence to regional guidelines are essential for timely approval. For expert guidance on dossier development, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance facilitates safe and effective clinical use of PCC worldwide, supporting patient care in critical bleeding situations.
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