Spinraza (nusinersen) is an antisense oligonucleotide from Biogen for 5q spinal muscular atrophy, given by intrathecal injection from single-dose 5 mL vials, with a low dose and a high dose regimen on the label and a refrigerated cold chain.
M Care Exports supplies Spinraza (nusinersen), marketed by Biogen, to hospital pharmacies, neurology and SMA centres, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 12 mg/5 mL vial, or the 28 mg and 50 mg vials used in the high dose regimen, send the destination, the strength and the quantity, and we quote per destination.
Nusinersen exporter and bulk supplier from India.
"We need a partner for Spinraza" is a typical enquiry from a hospital pharmacy that treats spinal muscular atrophy (SMA) or from a tender desk. M Care is a merchant-exporter: we quote against your specification and confirm which strengths your destination registers before we offer. Spinraza is not one line but up to three, because the US label and the EU SmPC list 12 mg/5 mL, 28 mg/5 mL and 50 mg/5 mL single-dose vials, one vial per carton. The 12 mg vial is used in the low dose regimen. The 50 mg and 28 mg vials are used in the high dose regimen, and the US label tells the pharmacy not to combine vials of different strengths or use partial vials to reach a dose. The quote therefore turns on which regimen the treating centre uses, the number of patients and doses, the cold-chain packing, the registration route in the destination and the Incoterms. We do not give a figure on this page.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
SMN2-directed antisense oligonucleotide, sourced and documented for export.
Spinraza is a survival motor neuron-2 (SMN2) directed antisense oligonucleotide. The US label (spinraza.com prescribing information, Biogen, Cambridge, MA) indicates it for spinal muscular atrophy in paediatric and adult patients, and the EU SmPC indicates it for 5q spinal muscular atrophy. It is given intrathecally by or under the direction of clinicians experienced in lumbar puncture, as a bolus over 1 to 3 minutes. The US label gives two regimens. The low dose regimen is a 12 mg dose every 14 days for three doses, a fourth 12 mg dose 30 days after the third, then 12 mg every 4 months. The high dose regimen is a 50 mg dose, a second 50 mg dose 14 days later, then 28 mg every 4 months. The EU SmPC describes the same two regimens: 12 mg on Day 0, 14, 28 and 63 then every 4 months, or 50 mg on Day 0 and Day 14 then 28 mg every 4 months. The EMA page lists Biogen Netherlands B.V. as the marketing authorisation holder, with the marketing authorisation issued on 30 May 2017. The UK emc page lists the product under Biogen Idec Ltd.
Active ingredient
Nusinersen sodium. SMN2-directed antisense oligonucleotide.
Forms and strengths
12 mg/5 mL (2.4 mg/mL) single-dose vial; 28 mg/5 mL (5.6 mg/mL) single-dose vial; 50 mg/5 mL (10 mg/mL) single-dose vial.
Indications
Nusinersen is an SMN2-directed antisense oligonucleotide given by intrathecal injection for 5q spinal muscular atrophy, supplied as single-dose 5 mL vials and marketed as Spinraza by Biogen.
Administration
Intrathecal. Solution for injection.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are hospital pharmacists in neurology and paediatric neurology units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Spinraza 12 mg vials for an SMA centre" or "We need a partner for nusinersen for a tender". Spinraza is a rare-disease, hospital-only medicine. Whether a destination has registered it, or allows an unlicensed or named-patient import, depends on that country's regulator, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria or the MHRA in the UK. M Care Exports confirms the route per enquiry and aligns the offer with it before quoting.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on nusinersen.
Order by regimen, because the vial strength follows the dose. The US label starts the low dose regimen with four 12 mg loading doses and then one 12 mg vial every 4 months. The high dose regimen uses two 50 mg loading doses 14 days apart, then one 28 mg vial every 4 months. A patient moving from the low dose to the high dose regimen receives a single 50 mg dose at least four months after the last 12 mg maintenance dose, then 28 mg every 4 months. The US label requires a platelet count, coagulation laboratory testing and quantitative spot urine protein testing at baseline and before each dose. The EU SmPC recommends platelet, coagulation and urine protein testing if clinically indicated, and advises considering hydrocephalus in patients who develop decreased consciousness. Allow the vial to reach room temperature without external heat. The US label says to administer within 4 hours of removal from the vial, and the EU SmPC says a dose drawn into the syringe and not used within 6 hours must be discarded. The EU SmPC says not to dilute it. The US label removes 5 mL of cerebrospinal fluid first, and the EU SmPC recommends removing a volume equal to the volume of Spinraza to be injected.
The documentation pack a regulator actually asks for.
Spinraza is a refrigerated product. The US label and the EU SmPC both say to store the vial at 2 to 8 °C in the original carton, protected from light, and not to freeze it. Both allow storage in the original carton at or below 30 °C for up to 14 days if no refrigeration is available. Unopened vials can go back into the refrigerator, but the total time out of refrigeration must not exceed 30 hours at a temperature that does not exceed 25 °C once removed from the carton. The EU SmPC gives a shelf life of 5 years. Export consignments are packed for a cold chain to the receiving site, and the packing and monitoring are agreed per shipment. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. We state the source and status of each line before quoting and make no claim to hold any manufacturer certification ourselves.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside nusinersen.
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The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for nusinersen.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Nusinersen supply, the specific questions.
What is the Spinraza price, and what sets the cost of a Spinraza injection?
We do not publish a price for Spinraza (nusinersen). For an importer, the landed cost depends on the strength and number of vials (12 mg, 28 mg or 50 mg), the regimen the centre uses, the quantity over the treatment course, the cold-chain packing, the destination's registration or import route, and the Incoterms. M Care Exports quotes per destination, so send the country, the strength and the number of doses and we confirm availability and terms.
What is the Spinraza high dose regimen?
The current US label and the EU SmPC both describe a high dose regimen alongside the low dose one. It is a 50 mg loading dose, a second 50 mg dose 14 days later, then a 28 mg maintenance dose every 4 months. Both documents also give a transition step for patients already on 12 mg: a single 50 mg dose at least 4 months after the last 12 mg dose, then 28 mg every 4 months. Which regimen is available depends on what each destination has registered, and we confirm that per enquiry.
What is Spinraza injection used for, and is it used for SMA?
Yes. Spinraza is indicated for the treatment of spinal muscular atrophy (SMA). The US label covers paediatric and adult patients, and the EU SmPC covers 5q spinal muscular atrophy. It is given intrathecally, into the fluid around the spinal cord, by or under the direction of clinicians experienced in lumbar puncture. SMA is the only indication stated in the labels we read, and we do not suggest any other use.
How does nusinersen compare with risdiplam on label facts?
Both are authorised in the EU for 5q SMA, and we do not recommend one over the other. Nusinersen (Spinraza, Biogen) is an antisense oligonucleotide given by intrathecal injection, with loading doses and then maintenance every 4 months. Risdiplam (Evrysdi, Roche Registration GmbH per the EMA page) is a small molecule taken by mouth once a day after a meal, and the EMA page says it allows the SMN2 gene to produce the full-length SMN protein. Treatment choice sits with the treating clinician and the destination's formulary.
Who is the Spinraza manufacturer, and who holds the licence?
Spinraza is marketed by Biogen. The US label states that it is manufactured for Biogen, Cambridge, Massachusetts. The EMA page and SmPC list Biogen Netherlands B.V. as the EU marketing authorisation holder, with the authorisation issued on 30 May 2017, and the UK emc page lists the product under Biogen Idec Ltd. M Care Exports is a merchant-exporter, not the manufacturer or holder, and we state the source of each line before quoting.
Is there a generic nusinersen, and how must the vials be stored?
Drugs@FDA lists Spinraza from Biogen as the only nusinersen application, with all three strengths shown as prescription products, and we did not find a generic nusinersen there. The EMA and emc pages we reviewed list Spinraza as the nusinersen product. Registration status can change, so we check it per destination. Storage is 2 to 8 °C in the original carton, protected from light, not frozen, with up to 14 days at or below 30 °C allowed if no refrigeration is available. See also CNS and neurology medicines.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
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