Eculizumab‑Aeeb Suppliers & Bulk Manufacturers
Available Forms: Injection for intravenous infusion
Available Strengths: 300 mg/20 mL (IV infusion),
Reference Brands: Soliris, Bkemv- Biosimilar of Soliris, Epysqli- Biosimilar of Soliris
Category:
Biosimilars
Biosimilars of Soliris (eculizumab) inhibit the complement protein C5, preventing its activation and reducing immune-mediated damage. They effectively treat conditions like PNH and aHUS. Benefits include similar efficacy, lower costs, increased patient access, and supporting affordable management of rare, severe complement-mediated diseases when used under medical supervision.
Eculizumab‑aeeb is available in Injection for intravenous infusion
and strengths such as 300 mg/20 mL (IV infusion),.
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, Eculizumab‑aeeb 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) |
Eculizumab‑aeeb 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:
Biosimilars of Soliris (eculizumab) are regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality in compliance with GMP and MDR standards. In the US, FDA approval requires extensive comparability data, clinical validation, and safety assessments. In the EU, CE marking certifies conformity with MDR regulations. These biosimilars undergo validation, stability testing, and audits, with detailed documentation including biosimilarity, clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to affordable, high-quality biosimilar therapies for rare hematologic and complement-mediated conditions worldwide.
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