Betahistine, Indian WHO-GMP supply for Ménière's disease and vertigo management.
Betahistine dihydrochloride is one of the few molecules on this site defined as much by where it cannot be sold as by where it can. First registered in Europe in the 1970s and now used as first-line therapy for Ménière's disease in more than 80 countries, it has been absent from the US market since the FDA withdrew its original 1972 approval, a gap that persists to this day. For hospital pharmacy buyers, licensed wholesalers and tender desks in the UK, the EU, the Gulf, Africa, Southeast Asia and Latin America, that history is irrelevant; betahistine remains a routine, well-established vestibular therapy with decades of prescribing experience behind it. M Care Exports sources betahistine dihydrochloride tablets from WHO-GMP certified Indian manufacturers for exactly that buyer set, with the US market explicitly out of scope for this listing.
Betahistine exporter and bulk supplier from India.
M Care Exports sources betahistine dihydrochloride tablets from WHO-GMP certified Indian manufacturing partners for procurement desks, licensed wholesalers, hospital pharmacy chains and tender buyers across our served export markets. We work from confirmed manufacturer stock positions and current regulatory dossiers for the destination country before any offer goes out, rather than quoting from a static catalogue. If you are a licensed importer, distributor or institutional buyer with a defined requirement, tell us the destination country, the strength and pack size you need, and whether the tender or registration calls for dihydrochloride or mesilate salt, and we will come back with a sourced, documented offer rather than a placeholder quote. We do not publish minimum order quantities, unit pricing or lead times on this page because they vary by manufacturer allocation, destination regulatory pathway and current freight conditions; a written enquiry gets you real, current numbers instead of a figure we would have to walk back later.
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.
Histamine analogue: weak H1 receptor partial agonist and H3 receptor antagonist, classified therapeutically as an anti-vertigo/vestibular agent, sourced and documented for export.
Betahistine dihydrochloride is an oral anti-vertigo agent used almost worldwide for Ménière's disease, but it carries an unusual regulatory footprint that procurement teams need to know before they source it. It is registered and prescribed in the UK, across the EU, in the Gulf, in most of Africa, in Southeast Asia and in Latin America, typically as 8 mg, 16 mg and 24 mg tablets dosed two to three times daily. It has never held FDA approval in the United States: the original 1966 approval was withdrawn in 1972, and no branded or generic betahistine product is currently FDA-cleared, so US buyers are legally out of scope for this listing. Core clinical use is Ménière's disease (vertigo, tinnitus, aural fullness, fluctuating hearing loss) and, in several markets, peripheral vestibular vertigo more broadly. Contraindicated in phaeochromocytoma; caution required in peptic ulcer history and bronchial asthma; not generally recommended in children or adolescents due to limited paediatric safety data; pregnancy and lactation data are limited, so use is restricted to situations where clinical benefit is judged to outweigh unknowns.
Active ingredient
Betahistine dihydrochloride (marketed in some countries as betahistine mesilate/mesylate, a different salt of the same active moiety). Histamine analogue: weak H1 receptor partial agonist and H3 receptor antagonist, classified therapeutically as an anti-vertigo/vestibular agent.
Forms and strengths
8 mg; 16 mg; 24 mg.
Indications
An orally administered histamine analogue used first-line for Ménière's disease, acting on inner-ear microcirculation and central vestibular compensation pathways to reduce the frequency and severity of vertigo attacks and associated tinnitus and aural fullness.
Administration
Oral. Tablets (immediate-release).
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.
This page is written for licensed importers, hospital and retail pharmacy wholesalers, and institutional or tender procurement desks in markets where betahistine is actually registered and prescribed: the UK, the EU, GCC states across the Gulf, Sub-Saharan and North African markets, Southeast Asia, and Latin America. India is excluded as a destination market in every case, in line with M Care's export-only model; we source from India and ship outward, we do not sell into the Indian domestic market. Because betahistine has no current US marketing authorization, US-based buyers are also out of scope for this specific listing regardless of intended use, and we would flag that mismatch rather than take an order we cannot legally fulfil. If your procurement need is for one of our served markets, we ask for the destination country, required strength, and the salt form your registration dossier specifies (dihydrochloride is the form most widely supplied; mesilate/mesylate appears in some national dossiers) so we can match the offer to a manufacturer actually registered for that market.
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 betahistine.
From a pharmacovigilance and dispensing standpoint, betahistine's risk profile is modest but not trivial, and it is worth stating the awkward points plainly rather than only the favourable ones. The absolute contraindication is phaeochromocytoma: betahistine's histamine-analogue activity can theoretically trigger catecholamine release from the tumour, and this is treated as a hard stop in every SmPC we have reviewed for this molecule, not a relative caution. Peptic ulcer history requires monitoring rather than avoidance, since histaminergic mechanisms can influence gastric acid secretion and there are post-marketing reports of ulcer symptom exacerbation. Bronchial asthma patients have shown clinical intolerance to betahistine in a minority of documented cases, so initiation in an asthmatic patient should be monitored rather than assumed safe by default. On drug interactions, the one that actually matters for a dispensing pharmacist is concurrent MAO inhibitor therapy, including the MAO-B selective agent selegiline used in Parkinson's disease, which reduces betahistine's metabolic clearance and can raise systemic exposure; a pharmacokinetic study specifically examined this combination given how often the same elderly patient population is prescribed both. Paediatric use is not well supported by safety data and most labels either restrict or advise against use in children and adolescents. Pregnancy and breastfeeding data remain limited rather than reassuring, so this is a benefit-versus-unknown-risk decision for the prescriber, not a settled safe-in-pregnancy molecule. None of this is a reason to avoid stocking betahistine, since it is a genuinely established, low-abuse-liability therapy; it is a reason to make sure the receiving pharmacy's product information matches these cautions and that batch documentation supports the destination country's own labelling requirements.
The documentation pack a regulator actually asks for.
M Care Exports is a merchant exporter, not a manufacturer: betahistine dihydrochloride tablets supplied through us are sourced from WHO-GMP certified Indian manufacturing partners, and M Care's own operating credential is ISO 9001:2015 for our export and quality-management processes. We do not hold, and do not claim, WHO-GMP or WHO-Prequalification certification ourselves; those certifications sit with the manufacturing facility, and we pass through the manufacturer's current WHO-GMP status, CoA and regulatory dossier with every offer rather than asserting our own manufacturing credential. For betahistine specifically, the regulatory point that matters most to a buyer is destination-country registration status: the molecule is well-established across the UK, EU, Gulf, Africa, Southeast Asia and Latin America, but it is not FDA-approved and cannot be legally supplied into the US retail or institutional pharmaceutical market, so US-market requests are outside what we can responsibly fulfil for this product. We confirm the manufacturer's registration status in your specific destination country, along with current CoA, stability data and any country-specific labelling requirement, before finalising any offer.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Not approved by the US FDA: original 1966 approval was withdrawn in 1972 and no betahistine product currently holds US marketing authorization; M Care does not supply this molecule for the US market.
Contraindicated in patients with phaeochromocytoma.
Use with caution and monitoring in patients with a history of peptic ulcer disease or bronchial asthma.
Not generally recommended for children and adolescents; paediatric safety data are limited.
Pregnancy and lactation data are limited; use restricted to cases where clinical benefit is judged to outweigh unknowns.
Not a controlled or scheduled substance; prescription-only status applies in markets where it is registered.
Adjacent lines procurement desks order alongside betahistine.
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 betahistine.
- 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.
Betahistine supply, the specific questions.
Why is betahistine not on your list of molecules available for the US market?
Betahistine (branded historically as Serc) received a limited FDA approval in 1966 that was withdrawn in 1972 after the agency found the supporting clinical evidence inadequate. No betahistine product currently holds FDA approval, and it is not legally marketable as a prescription drug in the United States. US patients who use it typically do so through compounding pharmacies, which is a different regulatory channel entirely and not one M Care Exports supplies into. If your requirement is for the US, we would need to discuss a different vertigo therapy rather than betahistine.
Which markets can M Care actually supply betahistine into?
Betahistine is registered and in routine clinical use across the UK, the EU, the Gulf Cooperation Council states, most of Sub-Saharan and North Africa, Southeast Asia, and Latin America, generally as a first-line Ménière's disease treatment. We supply into licensed-importer markets within that footprint. Each destination has its own registration and labelling requirements, so we confirm the specific country's regulatory status before quoting rather than assuming coverage.
What is betahistine actually prescribed for, and is it a general vertigo drug?
Its core, best-evidenced indication is Ménière's disease: recurrent spontaneous vertigo attacks with fluctuating hearing loss, tinnitus and a sensation of aural fullness. In several of our served markets the approved label extends to peripheral vestibular vertigo more broadly, but it is not indicated for central causes of dizziness (stroke, migraine-associated vertigo, or vertebrobasilar insufficiency), and prescribers are expected to confirm a peripheral vestibular diagnosis before initiating it.
What contraindications and monitoring points should a distributor's pharmacovigilance file flag?
Betahistine is contraindicated in patients with phaeochromocytoma, since the histamine-analogue mechanism can theoretically provoke catecholamine release from the tumour. It should be used cautiously and under monitoring in patients with a history of peptic ulcer disease, because histaminergic activity can influence gastric acid secretion, and in patients with bronchial asthma, where clinical intolerance has been reported in a minority of cases. It is not generally recommended for children and adolescents given the limited paediatric safety dataset, and pregnancy or lactation use is restricted to cases where the prescriber judges clinical benefit to outweigh the absence of robust human safety data.
Does betahistine interact with common co-prescribed medicines?
The interaction most frequently flagged in product literature is with monoamine oxidase inhibitors (including the MAO-B selective agent selegiline), which can reduce betahistine's metabolic clearance and raise systemic exposure; combined use warrants dose review. Because betahistine is a histamine analogue, it can theoretically blunt the effect of antihistamines taken for unrelated indications, though this is a pharmacodynamic caution rather than a documented major interaction. As with any Ménière's disease patient, co-prescribed vestibular sedatives (like prochlorperazine or cinnarizine used for acute attacks) are typically tapered off once betahistine maintenance therapy is established, since sedating agents work against the drug's central vestibular-compensation goal.
What dosage forms and strengths does M Care source, and how is betahistine typically dosed?
We source immediate-release oral tablets in 8 mg, 16 mg and 24 mg strengths, matching the presentations most widely registered across our export markets. Typical adult maintenance dosing in product labelling runs from 24 mg to 48 mg per day in divided doses, usually starting at a higher initial dose (commonly 16 mg three times daily) and titrating to the lowest effective maintenance dose, taken with food to reduce gastrointestinal discomfort. We do not set or quote a dosing regimen ourselves; that is a matter for the prescriber and the destination country's approved label, and pack sizes/regimens must match the importer's own registration dossier.
Is betahistine a controlled or scheduled substance?
No. Betahistine is a prescription-only medicine in the markets where it is registered, but it is not a controlled or scheduled substance under international narcotics or psychotropic conventions, and it carries no abuse-liability restrictions. The only substantive legal-status flag for exporters is the US non-approval described above, not a scheduling issue.
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.