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

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.

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.