Onasemnogene Abeparvovec Injectable Suppliers & Bulk Manufacturers

Available Forms: Injectable gene therapy

Available Strengths: Single-dose IV infusion providing 6 x 10^13 vector genomes (vg) per patient

Reference Brands: Zolgensma(US & EU)

Category: Cell & Gene Therapies

Onasemnogene abeparvovec Injectable is available in Injectable gene therapy and strengths such as Single-dose IV infusion providing 6 x 10^13 vector genomes (vg) per patient. 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, Onasemnogene abeparvovec Injectable is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Onasemnogene abeparvovec Injectable 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:

Onasemnogene abeparvovec (Zolgensma) is regulated in both the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality following GMP standards. In the US, FDA approval involved extensive clinical trials, safety evaluations, and GMP compliance. In the EU, CE marking certifies conformity with MDR standards for pediatric spinal muscular atrophy (SMA) treatment. These therapies undergo validation, stability testing, and audits, with detailed documentation including clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance grants access to innovative, life-changing gene therapy for SMA worldwide, supporting early intervention and improved long-term outcomes.