Protein C Concentrate Powder Generics - Manufacturers & Suppliers
Ceprotin(US)
| Product/Composition:- | Protein C Concentrate powder |
|---|---|
| Strength:- | 5,000 IU/vial |
| Form:- | Lyophilized Powder |
| Reference Brands:- | Ceprotin(US) |
| MOQ | As per the manufacturer batch size |
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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, 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.