
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
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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