Anti-Inhibitor Coagulant Complex (Aicc) Lyophilized Powder Suppliers & Bulk Manufacturers
Available Forms: Lyophilized Powder (Reconstituted for IV infusion)
Available Strengths: 500 units, 1000 units, and 2500 units
Reference Brands: FEIBA(US)
Category:
Blood Disorder
Anti-Inhibitor Coagulant Complex (AICC), like FEIBA, provides concentrated clotting factors, bypassing inhibitors in hemophilia. It restores blood clotting, controls bleeding episodes, and reduces bleeding severity. Benefits include rapid bleeding control, improved hemostasis, and saved lives during severe hemorrhages in patients with inhibitors.
Anti-Inhibitor Coagulant Complex (AICC) Lyophilized Powder is available in Lyophilized Powder (Reconstituted for IV infusion)
and strengths such as 500 units, 1000 units, and 2500 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, Anti-Inhibitor Coagulant Complex (AICC) Lyophilized 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) |
Anti-Inhibitor Coagulant Complex (AICC) Lyophilized 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:
Anti-Inhibitor Coagulant Complex (AICC), such as FEIBA, is approved in the US by the FDA and in the EU via EMA for managing bleeding in hemophilia patients with inhibitors. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical and manufacturing information, while the EMA ensures compliance with regional safety and quality requirements. For guidance on dossier preparation, regulatory strategies, and market access, visit PharmaTradz. Ensuring regional compliance is essential for the safe, effective, and timely approval of AICC products worldwide, supporting optimal hemophilia patient care.
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