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 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.

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.