Prothrombin Complex Concentrate (Pcc) Injection 250 IU to 300 IU 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.
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.
Prothrombin Complex Concentrate (Pcc) Injection — third party manufacturing & bulk supply
Prothrombin Complex Concentrate (Pcc) Injection 250 IU to 300 IU 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) Injection 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.
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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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