Motilium (domperidone) is licensed only for short-term relief of nausea and vomiting in adults and adolescents from 12 years and 35 kg upward, and licensed generic domperidone tablets and oral suspension are available in the UK and EU alongside the originator brand, though the molecule has never been approved by the FDA for any use in the United States.
M Care Exports supplies Motilium (domperidone), a peripherally acting dopamine D2-receptor antagonist marketed in the UK under the Zentiva label, alongside MHRA-licensed generic domperidone tablets and oral suspension sold under the INN name. It is authorised strictly short-term, up to seven days, for nausea and vomiting in adults and adolescents. M Care is a merchant exporter: we source Motilium and generic domperidone through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Domperidone exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and tender-desk orders, M Care quotes domperidone against buyer specification: brand (Motilium) or generic, 10 mg film-coated tablets or 1 mg/ml oral suspension, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because domperidone's 2014 MHRA/EMA safety review narrowed its licence to short-course use with cardiac contraindications and a maximum 30 mg daily dose, we confirm the buyer's intended formulary placement and patient information leaflet wording before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
Peripherally acting dopamine D2-receptor antagonist, antiemetic and prokinetic, sourced and documented for export.
Domperidone is a peripherally acting dopamine D2-receptor antagonist with antiemetic and prokinetic activity. It blocks dopamine receptors in the chemoreceptor trigger zone, outside the blood-brain barrier, and increases gastroduodenal motility, which is why it controls nausea and vomiting without the central sedative or extrapyramidal effects seen with centrally acting antiemetics. Since the EU's 2014 Article 31 safety review, the only licensed indication is short-term relief of nausea and vomiting in adults and adolescents aged 12 years and over weighing 35 kg or more; the older, broader dyspepsia and gastroparesis-type licences were withdrawn across UK and EU labelling. It is dosed orally as 10 mg film-coated tablets, up to three times daily, or as a 1 mg/ml oral suspension, and needs no reconstitution or cold-chain handling.
Active ingredient
Domperidone maleate. Peripherally acting dopamine D2-receptor antagonist, antiemetic and prokinetic.
Forms and strengths
10 mg film-coated tablet; 1 mg/ml oral suspension.
Indications
Domperidone, marketed as Motilium, is a peripherally acting dopamine D2-receptor antagonist licensed for short-term relief of nausea and vomiting in adults and adolescents. Supplied from Indian WHO-GMP facilities to regulated and semi-regulated markets outside the United States, where it holds no FDA approval.
Administration
Oral. Film-coated tablet and oral suspension.
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 domperidone are mainly hospital and retail pharmacy chains, licensed importers and wholesalers stocking a short-course antiemetic for adult and adolescent patients, plus MoH tender desks replenishing essential-antiemetic formulary lines. Because the licensed indication is narrow and short-term, procurement volumes track retail and hospital-pharmacy dispensing rather than chronic-therapy tender cycles. Domperidone is not on the WHO Model List of Essential Medicines, which names metoclopramide as its reference antiemetic, and the WHO AWaRe antibiotic classification does not apply to it, so formulary placement is set by each destination regulator rather than a WHO listing. It is not a controlled drug and needs no cold-chain lane. India is our origin. We do not sell into the Indian market. Domperidone is exported only.
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 domperidone.
The dosing detail that actually matters for domperidone is duration, not titration: both UK/EU labelling caps treatment at seven days without medical review, because the 2014 MHRA/EMA safety review found a small but real increase in ventricular arrhythmia and sudden cardiac death, concentrated in patients over 60, those on more than 30 mg a day, and anyone on concomitant CYP3A4 inhibitors or other QT-prolonging medicines. Dispensing checks should exclude patients with known cardiac conduction disease, electrolyte disturbance, moderate-to-severe hepatic impairment, or phaeochromocytoma, all contraindications listed in current UK/EU labelling. No reconstitution or premedication is required; it is a straightforward oral tablet or suspension, room-temperature stable, with no PVC-set or infusion-line considerations. The suspension's 1 mg/ml concentration matters for accurate paediatric-weight-band dosing where a country's labelling permits use below 12 years; check the destination SmPC before quoting that population, as UK/EU labelling itself restricts routine use to 12 years and 35 kg upward.
The documentation pack a regulator actually asks for.
Every domperidone shipment carries batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration, along with destination-language patient information leaflet artwork carrying the current cardiac and phaeochromocytoma contraindication wording mandated since the 2014 EU safety review.
How a licensed importer actually brings a consignment like this in is covered once, in the licensed import route guide, rather than repeated on every molecule 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 domperidone.
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 domperidone.
- 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.
Domperidone supply, the specific questions.
Does a generic version of Motilium exist?
Yes. MHRA-licensed generic domperidone 10 mg tablets and 1 mg/ml oral suspension are registered and marketed in the UK alongside the originator brand Motilium. Registration status for generic domperidone varies by destination country, so M Care checks local approval before quoting brand or generic against a specific order.
Can M Care supply Motilium to our market?
Yes, on an import basis. We source Motilium through licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
Is domperidone approved in the United States?
No. Domperidone has never been approved by the FDA for any indication in the US. It is accessible there only through an expanded-access investigational new drug application for specific gastrointestinal conditions in patients who have failed standard therapy. M Care does not supply into the US market on the strength of this molecule; our domperidone trade is with UK, EU, GCC and African buyers where it holds a standard marketing authorisation.
Why is domperidone only licensed for short-term use?
A 2014 EU-wide safety review (Article 31) found domperidone carries a small increased risk of serious ventricular arrhythmia and sudden cardiac death, higher in patients over 60, those taking more than 30 mg a day, or those on concomitant QT-prolonging medicines. UK and EU labelling responded by narrowing the licence to short-term relief of nausea and vomiting, capped at seven days without medical review, and adding cardiac and phaeochromocytoma contraindications.
What strengths and dosage forms of domperidone are available?
10 mg film-coated tablets and 1 mg/ml oral suspension, both dosed up to three times daily to a maximum of 30 mg per day in adults and adolescents aged 12 years and over weighing 35 kg or more. Tell us your required split between tablets and suspension and we quote accordingly.
Who should not take domperidone?
Patients with heart failure, prolonged QT interval, significant electrolyte disturbance, moderate-to-severe hepatic impairment, or phaeochromocytoma should not be dispensed domperidone, per current UK/EU labelling. These contraindications should appear on the patient information leaflet packed with every shipment.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.
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