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 helps manage thrombotic conditions by replacing deficient or dysfunctional protein C, which regulates blood clotting. It inhibits clot formation by degrading factors Va and VIIIa, reducing thrombosis risk. Benefits include restoring anticoagulant balance, preventing clotting in deficiency states, and supporting safe blood flow, especially during surgery or critical illness.
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.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
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.
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