Valoctocogene Roxaparvovec Infusion Suppliers & Bulk Manufacturers
Available Forms: Intravenous infusion
Available Strengths: A single-dose gene therapy designed to increase factor VIII production in hemophilia A patients
Reference Brands: Roctavian(US & EU)
Category:
Cell & Gene Therapies
Valoctocogene roxaparvovec (Roctavian) is a gene therapy that delivers a functional factor VIII gene via viral vectors, enabling the body to produce sustained, high levels of the clotting factor. It reduces bleeding episodes, decreases treatment burden, and improves quality of life in patients with severe hemophilia A.
valoctocogene roxaparvovec Infusion is available in Intravenous infusion
and strengths such as A single-dose gene therapy designed to increase factor VIII production in hemophilia A patients.
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, valoctocogene roxaparvovec 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) |
valoctocogene roxaparvovec 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:
Valoctocogene roxaparvovec (Roctavian) is regulated in the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involved extensive clinical trials and safety assessments, while in the EU, regulatory review is ongoing, with CE marking anticipated. These gene therapies undergo validation, stability testing, and audits, supported by detailed documentation, including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to innovative, long-lasting gene therapy treatments for hemophilia A worldwide, supporting improved patient outcomes and advanced healthcare.
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