Sibelium (flunarizine) is a calcium-channel-blocking migraine prophylactic that Janssen withdrew from the Irish market in November 2023 and never licensed in the UK, so sourcing increasingly runs through generic flunarizine channels as much as the originator brand.
M Care Exports sources Sibelium (flunarizine dihydrochloride) and generic flunarizine capsules for hospital pharmacies and MoH tender desks across our GCC, African and Southeast Asian markets. We are a merchant exporter, not a manufacturer: every order routes through licensed Indian distribution and WHO-GMP manufacturing partner channels against the buyer's own specification.
Flunarizine exporter and bulk supplier from India.
For hospital and tender orders, M Care quotes flunarizine capsules against buyer specification: originator Sibelium where a tender names the Janssen brand and the product still carries active registration in that market, or a generic flunarizine line from a WHO-GMP partner site where the tender is INN-based. Because Janssen withdrew Sibelium's marketing authorisation in Ireland on 30 November 2023 and the product has no UK marketing authorisation, buyers in regulated markets increasingly specify generic flunarizine or route the enquiry as a named-patient import; we confirm current brand registration status in the destination market before quoting.
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.
Diphenylmethylpiperazine derivative; selective calcium-channel blocker with secondary antihistamine, serotonergic and dopamine D2-blocking activity, sourced and documented for export.
Flunarizine is a diphenylmethylpiperazine derivative classed as a selective calcium-channel blocker, though its migraine-prophylactic effect is thought to owe as much to secondary antihistamine, serotonergic and dopamine D2-blocking activity as to calcium-channel antagonism itself.
Its core licensed indication, per the Irish and other EU SmPCs, is prophylaxis of migraine in adults, with paediatric use for migraine reported in the clinical literature reviewed by NICE and reflected in some destination-country labelling; buyers should check the indication wording their own regulator has approved rather than assume a single global label. It is not approved in the US or Japan and remains unlicensed in the UK, where NICE's evidence summary (ESUOM33, September 2014) reviews its off-label use in specialist migraine services and records the most common adverse effect as weight gain.
Flunarizine is dispensed as a 5 mg capsule or tablet, taken orally once daily at night. It is a room-temperature oral solid dosage form: no cold chain, no reconstitution, which keeps freight simple for GCC and African tender lanes.
Active ingredient
flunarizine dihydrochloride. Diphenylmethylpiperazine derivative; selective calcium-channel blocker with secondary antihistamine, serotonergic and dopamine D2-blocking activity.
Forms and strengths
5 mg capsule or tablet.
Indications
Calcium-channel-blocking agent licensed in the EU and several GCC, African and Southeast Asian markets for migraine prophylaxis in adults; not approved in the US, Japan or the UK.
Administration
oral. Capsule or tablet.
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 for flunarizine through M Care are chiefly hospital and neurology-clinic pharmacists managing migraine-prophylaxis formularies, MoH tender desks in our GCC and African markets running CNS procurement rounds, and licensed importers and wholesalers who hold the import permit for their territory. UK-based buyers typically enquire on a named-patient or specialist-import basis, since flunarizine has no UK marketing authorisation.
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 flunarizine.
Flunarizine's dosing is age-banded, not weight-banded: 10 mg once daily at night for adults aged 18 to 64, and 5 mg once daily at night for patients 65 and over, per the Irish SmPC/PIL for Sibelium. If no meaningful improvement is seen after two months, the patient is classed a non-responder and the drug should be stopped rather than continued on the assumption that benefit will emerge later. Where a response is seen, maintenance dosing is taken with two consecutive drug-free days built into every week, and treatment is capped at six months before a re-evaluation; it should only restart if migraine relapses.
The contraindications a receiving pharmacy needs to screen for before dispensing are current depressive illness or a history of recurrent depression, and pre-existing Parkinson's disease or other extrapyramidal disorders. Flunarizine can itself provoke or unmask extrapyramidal symptoms and depression, particularly in elderly patients, and weight gain (a very common effect, affecting more than 1 in 10 patients per the Irish PIL) and drowsiness (a common effect, affecting fewer than 1 in 10) are frequent enough to flag at counselling. There is no reconstitution, cold-chain or extravasation concern with this oral capsule; the clinical risk sits in patient selection and monitoring for mood and movement-disorder symptoms over the treatment course, not in handling.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, flunarizine ships and stores at controlled room temperature with no cold-chain validation required; M Care's documentation for each shipment covers batch-level certificate of analysis, CDSCO (Central Drugs Standard Control Organization, India) export paperwork from the Mumbai desk, and CTD/eCTD-aligned dossier support where a destination regulator (SFDA, MOHAP, NAFDAC, PPB, SAHPRA or an equivalent national authority) requires local registration before import.
On brand versus generic: Janssen withdrew Sibelium's Irish marketing authorisation in November 2023 and never sought UK licensure, though the brand continues to be marketed under active registration in a number of other markets outside the EU and UK. Generic flunarizine capsules are manufactured and registered in multiple licensed-generic markets across Asia, Latin America and the Middle East. M Care sources either the originator brand, where it remains obtainable in the destination market, or a generic flunarizine line from a WHO-GMP partner site, and confirms current registration status with the buyer before quoting; we hold no manufacturing licence or WHO-GMP certification of our own.
Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.
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 flunarizine.
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 flunarizine.
- 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.
Flunarizine supply, the specific questions.
Is flunarizine licensed in the UK?
No. Flunarizine has no UK marketing authorisation and is unlicensed there; NICE's evidence summary ESUOM33 reviews its off-label use for migraine prophylaxis in specialist services. UK buyers typically source it on a named-patient or specialist-import basis, and M Care structures the export documentation accordingly.
Is Sibelium still available, or has it been discontinued?
It depends on the market. Janssen withdrew Sibelium's marketing authorisation in Ireland on 30 November 2023, though the brand remains under active registration in a number of other markets outside the EU and UK. M Care checks current brand availability in your destination market before quoting; where the brand is no longer obtainable, we quote a generic flunarizine line instead.
Is there a generic version of flunarizine?
Yes. Generic flunarizine capsules are manufactured and registered in multiple licensed markets across Asia, Latin America and the Middle East, alongside Janssen's originator Sibelium where it remains registered. M Care can source either against a tender's brand or INN specification.
What is flunarizine licensed to treat?
Its core licensed indication, per EU SmPCs including the Irish label, is prophylaxis of migraine in adults. Paediatric use for migraine is reported in the clinical literature reviewed by NICE and reflected in some destination-country labelling, so buyers should confirm the exact indication wording their own regulator has approved.
Who should not be prescribed flunarizine?
The SmPC contraindicates flunarizine in patients with current depressive illness or a history of recurrent depression, and in those with pre-existing Parkinson's disease or other extrapyramidal disorders, since the drug can itself provoke depression or extrapyramidal symptoms, particularly in elderly patients.
Does flunarizine need cold-chain shipping?
No. It is a 5 mg oral capsule or tablet stored at controlled room temperature, so it ships on standard ambient, moisture-controlled logistics rather than the validated cold-chain lanes M Care uses for biologics.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-11.
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.
- Approved product information of the supplying manufacturer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.