Suppliers and packagers for SPINRAZA

SPINRAZA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531	NDA	Biogen Inc.	64406-036-01	1 VIAL, SINGLE-USE in 1 BOX (64406-036-01) / 5 mL in 1 VIAL, SINGLE-USE	2026-03-27
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531	NDA	Biogen Inc.	64406-037-01	1 VIAL, SINGLE-USE in 1 BOX (64406-037-01) / 5 mL in 1 VIAL, SINGLE-USE	2026-03-27
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531	NDA	Biogen Inc.	64406-058-01	1 VIAL, SINGLE-USE in 1 BOX (64406-058-01) / 5 mL in 1 VIAL, SINGLE-USE	2016-12-23

Suppliers and packagers for SPINRAZA

Last updated: April 24, 2026

Who Supplies Spinraza (nusinersen) and What Parts of the Value Chain They Cover

Spinraza (nusinersen) is supplied through a vertically coordinated ecosystem spanning the active pharmaceutical ingredient (API) manufacturer(s), drug product/formulation and fill-finish, and specialized packaging/logistics required for an intrathecal biologic. The program is tied to Biogen’s global manufacturing network and contract manufacturing relationships used to produce and distribute nusinersen at commercial scale (including periodic supply runs for approved markets).

Who supplies the active ingredient and drug product for Spinraza?

Spinraza is marketed and supplied by Biogen. For manufacturing, the nusinersen product is made by contract manufacturing and fill-finish organizations supporting Biogen’s supply chain. Publicly available regulatory filings and product documentation typically identify the manufacturing sites and responsible parties by geography and dosage form (vialed solution intended for intrathecal administration), rather than a single “supplier” in the retail sense.

Below is the supply-chain structure used for Spinraza:

Supply-chain layer	What it covers	Typical supplier type for Spinraza
API	Nusinersen drug substance	Specialty API manufacturer under contract and/or within Biogen’s manufacturing network
Drug product	Final drug substance to finished sterile injectable	Sterile biologic drug product manufacturer and formulation developer under contract/authorized site
Fill-finish	Vial filling, stopper crimping, labeling, secondary packaging	Sterile fill-finish site for prefilled single-dose vials
Quality/release	Batch release, stability, GMP documentation	Biogen quality system and regulatory release mechanisms at responsible sites
Supply logistics	Temperature-controlled distribution, intrathecal-ready presentation	Distribution and cold-chain logistics providers used by Biogen and regional wholesalers

Biogen remains the commercial supplier of Spinraza across regions (ordering, distribution ownership, pharmacovigilance coordination), while manufacturing is executed through authorized GMP sites.

Which manufacturing sites and contractors are known from public documentation?

Public regulatory dossiers and market-authorized product documentation for nusinersen commonly disclose manufacturing site addresses and the organizations responsible for drug substance, drug product, and/or release.

What you can rely on from these disclosures in due diligence terms is the pattern:

• Finished product is produced in sterile injectable manufacturing and fill-finish GMP facilities
• API is produced in nucleic acid synthesis and purification-capable GMP facilities
• Multiple batches are produced through a multi-site network to maintain continuity of supply

How does the Spinraza supply chain typically operate across dosage form?

Spinraza is supplied as a single-dose vial intended for intrathecal administration. The supply chain is therefore built around:

• Sterile manufacturing controls (aseptic processing controls)
• Single-dose vial presentation
• Cold-chain handling and controlled storage/transport per label requirements
• Traceability for batch-level pharmacovigilance

This matters for supplier mapping because intrathecal biologics shift the critical supplier competencies from “commodity sterile packaging” to:

• Sterile manufacturing and aseptic fill-finish capability
• Analytics and release testing that align with nucleic acid impurity profiles and stability requirements
• Documentation readiness for regulatory submissions by region

What can be treated as “suppliers” in a practical investment/R&D diligence model?

In commercial due diligence, the relevant “suppliers” for Spinraza typically fall into four buckets you can map to contracts, invoices, and regulatory responsibilities:

1. Commercial supplier and global brand owner

   • Biogen (Spinraza product supply ownership, market distribution, pharmacovigilance system owner)

2. Drug substance (API) manufacturing

   • GMP API manufacturer(s) operating under contract and/or Biogen-approved manufacturing network sites

3. Drug product manufacturing and fill-finish

   • Sterile drug product and fill-finish organization(s) making nusinersen final presentation into intrathecal dosing vials

4. Quality release and regulatory compliance

   • Responsible manufacturing and quality release entities within Biogen and authorized GMP sites supporting batch release documentation

Key diligence checks to identify the exact supplier list from records

Even when the market-facing “supplier” is clear (Biogen), the exact list of API and fill-finish sites must be pulled from:

• Regulatory product dossiers in each jurisdiction
• Product labeling inserts and SmPC sections for “manufactured by” and “released by” references
• Batch records and distributor documentation used for traceability

These sources identify:

• The manufacturing site names and addresses tied to each stage
• Which entities are responsible for manufacture, release, and packaging

What is the purchasing and contracting reality for Spinraza?

For an intrathecal biologic at this scale, procurement is typically contract-based at the stage level:

• API contract manufacturing for drug substance runs
• Fill-finish and sterile drug product manufacturing under GMP agreements
• Regional distribution via wholesalers and specialized cold-chain logistics partners

The commercial “supplier” is still Biogen, but manufacturing and packaging procurement generally runs through multiple manufacturing and logistics contracts.

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Key Takeaways

• Biogen supplies and distributes Spinraza globally as the commercial product owner.
• Nusinersen manufacturing is executed through authorized GMP supplier sites covering API, sterile drug product, and fill-finish, with release under Biogen’s quality system and authorized manufacturing responsibilities.
• Supplier mapping for investment or R&D diligence must rely on jurisdictional regulatory dossiers and labeling documentation that identify “manufactured by” and “released by” entities by stage and site.

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FAQs

1. Is Biogen the supplier of Spinraza or only the marketer?
   Biogen is the commercial supplier of Spinraza and coordinates global distribution and pharmacovigilance, while manufacturing is performed by authorized GMP sites.

2. How many supplier types does Spinraza have in practice?
   At minimum, the chain spans API, sterile drug product/fill-finish, and quality release, with regional distribution and cold-chain logistics supporting delivery.

3. Do supplier names change across countries?
   Yes. The manufacturing site list is generally stable by approval pathway, but the “manufactured by/released by” references can differ across jurisdictions based on authorized site registrations.

4. Why does supplier mapping matter for nusinersen specifically?
   Intrathecal biologics require sterile manufacturing controls, rigorous analytics, and tight batch traceability, so supplier capability and quality release responsibilities are critical.

5. Where do you find the exact manufacturing supplier list for Spinraza?
   The exact list is contained in regulatory dossiers and jurisdictional labeling/SmPC sections that name the manufacturing and release entities and their sites.

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References (APA)

[1] Biogen. (n.d.). Spinraza (nusinersen) prescribing information / product information. Biogen.
[2] European Medicines Agency. (n.d.). Spinraza (nusinersen) EPAR and product information. EMA.
[3] U.S. Food and Drug Administration. (n.d.). Spinraza (nusinersen) label and regulatory information. FDA.