Voretigene Neparvovec Infusion Suppliers & Bulk Manufacturers
Available Forms: Subretinal injection
Available Strengths: Adeno-associated virus (AAV) vector administered via subretinal injection
Reference Brands: Luxturna(US & EU)
Category:
Cell & Gene Therapies
Voretigene neparvovec (Luxturna) is a gene therapy that delivers a functional RPE65 gene via viral vectors, restoring vision in inherited retinal disease. It improves visual function, enhances light perception, and helps maintain retinal health. Benefits include potential vision stabilization and improved quality of life with a single-dose treatment.
voretigene neparvovec Infusion is available in Subretinal injection
and strengths such as Adeno-associated virus (AAV) vector administered via subretinal injection.
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, voretigene neparvovec 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) |
voretigene neparvovec 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:
Voretigene neparvovec (Luxturna) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality per GMP standards. In the US, FDA approval involved comprehensive clinical trials and validation. In the EU, CE marking certifies conformity with MDR standards for gene therapy applications. These products undergo validation, stability testing, and audits, with detailed documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective gene therapy for inherited retinal diseases, supporting improved vision outcomes and quality of life globally.
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