Plasma Protein Fraction (Ppf) Powder Suppliers & Bulk Manufacturers
Available Forms: Lyophilized Powder or Liquid
Available Strengths: 50 mL, 250 mL, or 500 mL
Reference Brands: Plasmanate (US), Octaplas LG, Biotest Plasma (EU)
Category:
Plasma Products
Plasma Protein Fraction (PPF) provides essential plasma proteins, including albumin and clotting factors, supporting blood volume and coagulation. It restores plasma volume, improves hemodynamic stability, and replaces deficient plasma proteins in various conditions. Benefits include quick plasma protein replenishment, blood volume expansion, and enhanced clotting, supporting critical patient care.
Plasma Protein Fraction (PPF) powder is available in Lyophilized Powder or Liquid
and strengths such as 50 mL, 250 mL, or 500 mL.
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, Plasma Protein Fraction (PPF) 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) |
Plasma Protein Fraction (PPF) 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:
Plasma Protein Fraction (PPF) powder, such as Plasmatate and Octaplas LG, is approved in the US by the FDA and in the EU via EMA for replacing plasma proteins in various clinical conditions. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and manufacturing information, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring thorough regulatory compliance is essential for the safe, effective, and timely approval of PPF powder products worldwide, supporting optimal patient care.
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