Nusinersen Intrathecal Injection 12 mg/5ml Suppliers & Bulk Manufacturers
Available Forms: Intrathecal Injection
Available Strengths: 12 mg/5ml
Reference Brands: Spinraza(US)
Category: Orphan Drugs
Nusinersen is an antisense oligonucleotide that enhances the production of survival motor neuron protein by modifying RNA splicing. It effectively treats spinal muscular atrophy (SMA), improving muscle strength, motor function, and survival. Benefits include increased mobility, reduced ventilator dependence, and enhanced quality of life for SMA patients.
Product Description:
Nusinersen, marketed as Spinraza, is approved in the US by the FDA and in the EU via EMA for spinal muscular atrophy (SMA). Regulatory approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe administration, and worldwide availability, helping SMA patients globally access life-saving treatment and improve quality of life.
Nusinersen Intrathecal Injection — third party manufacturing & bulk supply
Nusinersen Intrathecal Injection 12 mg/5ml is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Nusinersen Intrathecal Injection listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Nusinersen Intrathecal Injection →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Nusinersen is used for the treatment of spinal muscular atrophy (SMA), a rare genetic neuromuscular disorder that causes progressive muscle weakness and loss of motor function. It helps improve motor outcomes and slow disease progression by increasing the production of survival motor neuron (SMN) protein.
Nusinersen is made from the active pharmaceutical ingredient nusinersen sodium, an antisense oligonucleotide designed to modify SMN2 gene splicing and increase functional SMN protein levels in the body.
The international trade name is Spinraza.
Nusinersen is developed and manufactured by Biogen.
The complete generic name is nusinersen sodium.
The brand name is Spinraza.
Nusinersen is manufactured for global supply by Biogen through approved GMP facilities in the USA and EU, with distribution across major international markets for rare disease treatment.
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