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 (Zolgensma) delivers a functional copy of the SMN1 gene via gene therapy, increasing SMN protein production. It improves motor function, prolongs survival, and reduces the need for ventilatory support in SMA patients. Offers a one-time, lifelong treatment for early intervention in SMA.
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.
|
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) |
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.
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