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) 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.

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.