Etranacogene Dezaparvovec. Infusion Suppliers & Bulk Manufacturers
Available Forms: Intravenous infusion
Available Strengths: Single infusion product designed to produce sustained factor IX levels in hemophilia B patients, dosage individualized based on patient weight
Reference Brands: Hemgenix (US & EU)
Category: Cell & Gene Therapies
Etranacogene dezaparvovec. infusion is available in Intravenous infusion and strengths such as Single infusion product designed to produce sustained factor IX levels in hemophilia B patients, dosage individualized based on patient weight. 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, Etranacogene dezaparvovec. infusion 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) |
Etranacogene dezaparvovec. infusion 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:
Etranacogene dezaparvovec (AMECVIT) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP and MDR standards. In the US, FDA approval involved extensive clinical validation, safety assessments, and comparability data. In the EU, CE marking certifies conformity with MDR regulations. These gene therapies undergo validation, stability testing, and audits, supported by comprehensive documentation including safety profiles, clinical trial results, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring regulatory compliance guarantees access to innovative gene therapies supporting hemophilia B management worldwide, promoting effective treatment and improved patient outcomes.
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