Prothrombin Complex Concentrate (Pcc) 2 Mg Injectable Concentrates 1,200 IU/vial 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.
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.
Prothrombin Complex Concentrate (Pcc) 2 Mg Injectable Concentrates — third party manufacturing & bulk supply
Prothrombin Complex Concentrate (Pcc) 2 Mg Injectable Concentrates 1,200 IU/vial is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Prothrombin Complex Concentrate (Pcc) 2 Mg Injectable Concentrates listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Prothrombin Complex Concentrate (Pcc) 2... →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Prothrombin Complex Concentrate (PCC) injection is used for the rapid treatment and prevention of bleeding caused by deficiencies of vitamin K-dependent clotting factors. It is commonly used to reverse the effects of warfarin or other vitamin K antagonist anticoagulants in cases of major bleeding or before urgent surgery.
Prothrombin Complex Concentrate injection is made from purified human plasma that contains a combination of vitamin K-dependent clotting factors, mainly factors II, VII, IX, and X.
Common trade names include Kcentra, Octaplex, Profilnine, Bebulin VH, and Cofact.
Prothrombin Complex Concentrate injections are manufactured by pharmaceutical companies such as CSL Behring, Octapharma, Pfizer, and Sanquin.
The generic name is prothrombin complex concentrate.
Brand names include Kcentra (USA), Octaplex (EU and international markets), Profilnine (USA), Bebulin VH (USA), and Cofact (Europe and Canada).
Prothrombin Complex Concentrate injection is manufactured in several countries including the United States, Germany, Austria, the Netherlands, and other European countries depending on the manufacturer.
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