Elivaldogene Autotemcel Infusion Suppliers & Bulk Manufacturers
Available Forms: Intravenous infusion
Available Strengths: A personalized gene therapy designed to halt or slow ALD progression, dosed based on weight, administered as a single infusion in specialized treatment centers
Reference Brands: Skysona(US & EU)
Category:
Cell & Gene Therapies
Elivaldogene autotemcel (Skysona) is a gene therapy that delivers a functional ABCD1 gene via viral vectors, halting or slowing adrenoleukodystrophy (ALD) progression. It reduces neurological decline, stabilizes cognitive function, and improves quality of life when administered early in specialized centers, offering long-term disease management.
Elivaldogene autotemcel Infusion is available in Intravenous infusion
and strengths such as A personalized gene therapy designed to halt or slow ALD progression, dosed based on weight, administered as a single infusion in specialized treatment centers.
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, Elivaldogene autotemcel 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) |
Elivaldogene autotemcel 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.
Product Description:
Elivaldogene autotemcel (Skysona) is regulated in the US and EU, 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 requirements, with ongoing approval processes in some member states. These gene therapies undergo validation, stability testing, and audits, supported by comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring regulatory compliance guarantees access to innovative treatments supporting early intervention in cerebral ALD worldwide.
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