Fresh Frozen Plasma (Ffp) Powder For Reconstitution Or Liquid Suppliers & Bulk Manufacturers
Available Forms: liquid units or lyophilized (freeze-dried) powder
Available Strengths: available in 200-250 mL units
Reference Brands: No specific brands
Category:
Plasma Products
Frozen Plasma (FFP) provides all essential coagulation factors, volume, and plasma proteins. It corrects coagulopathies, restores blood volume, and supports clot formation. Benefits include rapid correction of clotting deficiencies, effective bleeding control, improved hemodynamic stability, and support during surgeries or trauma, enhancing patient recovery.
Fresh Frozen Plasma (FFP) powder for reconstitution or liquid is available in liquid units or lyophilized (freeze-dried) powder
and strengths such as available in 200-250 mL units.
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, Fresh Frozen Plasma (FFP) powder for reconstitution or liquid 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) |
Fresh Frozen Plasma (FFP) powder for reconstitution or liquid 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:
Frozen Plasma (FFP), used for coagulation correction and volume resuscitation, is regulated in the US by the FDA and in the EU via EMA approval pathways. Regulatory approval requires a comprehensive dossier including manufacturing standards, donor screening, safety, efficacy, and pharmacovigilance plans. In the US, FDA review assesses clinical and quality data, while EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of FFP products worldwide, supporting optimal patient care in critical bleeding and coagulation disorders.
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