Protein C Concentrate Powder Suppliers & Bulk Manufacturers

Available Forms: Lyophilized Powder

Available Strengths: 5,000 IU/vial

Reference Brands: Ceprotin(US)

Category: Plasma Products

Protein C Concentrate powder is available in Lyophilized Powder and strengths such as 5,000 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, Protein C Concentrate powder is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Protein C Concentrate powder 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: Protein C concentrate powder, marketed as Ceprotin, is approved in the US by the FDA and in the EU via EMA for treating congenital or acquired Protein C deficiency. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of Protein C concentrate worldwide, supporting patient safety and thrombosis management.