Artemether-Lumefantrine Exporter and Supplier from India
You are sourcing an ACT antimalarial that will clear a Global Fund or national malaria programme audit, and you need it shipped from a manufacturing line that already carries WHO prequalification. M Care Exports supplies Artemether-Lumefantrine as the 20/120mg adult tablet, the weight-banded paediatric dispersible tablet and the 80/480mg high-strength tablet, sourced from WHO-PQ-listed Indian manufacturing lines. We are a merchant-exporter trading since 2003, not the manufacturer, so we sit alongside your procurement team on dossier, CoPP and tender compliance rather than in place of the marketing authorisation holder.
Bulk Artemether-Lumefantrine for malaria-programme procurement
Artemether-Lumefantrine moves in volumes almost no other molecule matches, because it sits at the centre of donor-funded malaria treatment across sub-Saharan Africa. Demand is structured, seasonal and tender-driven: Global Fund grant recipients, national malaria control programmes and central medical stores buy by weight-band pack rather than by single unit. M Care aggregates that requirement against the batch-release schedules of WHO-prequalified Indian lines, so a distributor bidding into a Ministry of Health framework, or a wholesaler holding pre-season buffer stock, works with one export desk instead of chasing individual factories. We are honest about our role: the WHO-PQ listing and the marketing authorisation belong to the source manufacturer, M Care's own credential is ISO 9001:2015, and we supply from those prequalified lines under a transparent chain of custody.
Weight-band pack configurations
Adult 6x4 (24-tablet) packs down to the 6x1 paediatric pack, matched to the WHO under-15, 15-25, 25-35 and 35kg-plus dosing bands that tender specifications call out by name.
Source manufacturer batch minimums
Order quantities follow the source manufacturer's batch-release minimum rather than an arbitrary figure we invent. We confirm the live minimum against the specific line before you commit to a bid.
Season-aligned scheduling
Malaria transmission peaks after the rains, so we phase despatch against your programme's pre-season buffer window instead of shipping a single lump that ages on the shelf.
Reference-brand equivalence
Reference brands buyers benchmark against include the Novartis originator Coartem (marketed as Riamet in some markets) and Indian generic equivalents such as Lumerax. We supply generic Artemether-Lumefantrine from prequalified Indian manufacturers.
Artemether-Lumefantrine at a glance: fixed-dose ACT, weight-banded 6-dose course
Active combination
Artemether (fast-acting artemisinin schizonticide, roughly 2-hour half-life) with lumefantrine (long half-life partner, 3 to 6 days) in a single fixed-dose tablet. The dual mechanism protects the artemisinin component against resistance.
Strengths stocked
20/120mg adult tablet, 20/120mg dispersible paediatric tablet, and the 80/480mg high-strength tablet (bioequivalent to four standard tablets) that cuts pill burden at the top weight band.
Dosing schedule (reference)
Twice-daily 6-dose course over three days at 0, 8, 24, 36, 48 and 60 hours, with 1 to 4 tablets per dose set by patient weight band. Shown as context, not patient instruction.
Formulation and handling
Absorption of lumefantrine rises sharply when taken with a fat-containing meal or milk feed. Store below 30C, protect from moisture; the dispersible tablet disperses in a small volume of water for infants.
Regulatory class
WHO Model List of Essential Medicines since 2002 and Essential Medicines for Children since 2007. ATC P01BF01. Prescription antimalarial in importing markets.
Scope boundary
Indicated for uncomplicated P. falciparum only. Severe or complicated malaria is a separate protocol treated with injectable artesunate, which is a different product line.
Buyers we supply Artemether-Lumefantrine to
The buyer profile for this molecule is unusually concentrated on the public and donor-funded channel, which shapes the paperwork and the packaging we prepare for you.
Tender and framework distributors
Importers bidding into Global Fund principal-recipient or national malaria control programme tenders, who need WHO-PQ provenance and a CoPP that survives technical evaluation.
Central medical stores and government buyers
Public procurement agencies and central medical stores across Africa, GCC and SE Asia buying weight-band packs against annual malaria-season forecasts.
Regional wholesalers and stockists
Distributors holding pre-season buffer stock for private clinics and pharmacy chains in endemic markets, who value phased despatch over a single large drop.
NGO and faith-based health networks
Mission hospital groups and NGO supply hubs treating uncomplicated malaria at community level, often needing the paediatric dispersible presentation in quantity.
Safety-critical facts buyers should brief their downstream on
Artemether-Lumefantrine is a prescription antimalarial and the notes below are reference context for procurement and regulatory teams, not clinical advice for any individual patient. It is indicated only for uncomplicated P. falciparum malaria. Patients with signs of severe or complicated malaria require a different protocol built on injectable artesunate, and mixing up the two lines at facility level is a genuine risk worth flagging in your product training.
The most important labelled warning is cardiac: lumefantrine can prolong the QT interval. The combination is contraindicated in patients with congenital or acquired QT prolongation, a family history of sudden death, symptomatic cardiac arrhythmia, clinically relevant bradycardia, or electrolyte disturbance such as hypokalaemia or hypomagnesaemia, and where other QT-prolonging medicines are co-administered. Efficacy also depends on absorption, so the standard counselling is that each dose is taken with food or milk, because lumefantrine bioavailability rises many-fold in the presence of dietary fat. The full 6-dose course must be completed to prevent recrudescence and to protect the artemisinin component against resistance.
Written for professional buyers and importers, not as medical advice. Prescribing decisions sit with the treating clinician and the approved label in your market.
Export and registration documents we compile with you
Antimalarial tenders are won or lost on the dossier. Here is what M Care genuinely provides alongside your registration or bid, drawn from the source manufacturer's records plus our own export documentation.
CTD dossier support
We compile the Common Technical Document alongside you, drawing the quality and stability data from the WHO-PQ-listed source manufacturer for your national registration filing.
CoPP and WHO-PQ evidence
Certificate of Pharmaceutical Product plus the manufacturer's WHO prequalification listing reference, the two documents technical evaluators check first on a malaria tender.
Batch and quality records
Certificate of Analysis and manufacturer batch-release documentation per consignment, with the GMP certificate of the source manufacturing line.
Shipment and origin paperwork
Certificate of Origin, packing list, commercial invoice and export-market-specific labelling, coordinated so the consignment clears at destination without a documentation hold.
Stability and storage data
Zone IVb stability data supporting hot-and-humid climate shelf life, relevant to African and SE Asian storage conditions.
Molecules buyers source alongside Artemether-Lumefantrine.
Doxycycline
Tetracycline used for malaria prophylaxis in travellers, a complementary antimalarial line.
Azithromycin
Macrolide deployed in mass drug administration and atypical-pathogen cover in endemic settings.
Ciprofloxacin
Broad-spectrum fluoroquinolone for febrile co-infection management in the same buyer basket.
How ordering works.
- Send your specification Tell us the strength mix (20/120 adult, paediatric dispersible, 80/480), pack configuration, destination market and whether this is a tender bid or open stock.
- We confirm source line and pricing We match the requirement to a WHO-PQ-listed Indian manufacturing line, confirm the current batch-release minimum, and return pricing on request with lead time.
- Dossier and sampling We compile the CTD, CoPP and CoA package with you and arrange registration samples where the destination regulator requires them.
- Production slot and despatch On confirmation we book the batch slot, phase despatch against your malaria-season window, and hand over full shipment and origin documentation.
Artemether-Lumefantrine supply, the specific questions.
Is M Care the manufacturer of Artemether-Lumefantrine, and do you hold WHO prequalification?
No. M Care Exports is a merchant-exporter and wholesaler trading since 2003, not a manufacturer. The WHO prequalification and marketing authorisation belong to the source manufacturer. We supply from WHO-PQ-listed Indian manufacturing lines and compile the CTD dossier and CoPP alongside your team. Our own quality credential is ISO 9001:2015.
Which strengths and presentations can you supply?
The 20/120mg adult tablet, the 20/120mg paediatric dispersible tablet for children of 5 kg and above, and the 80/480mg high-strength tablet (bioequivalent to four standard tablets) that reduces pill burden at the top weight band. Pack configurations follow the WHO weight-band 6-dose course. Generic brands buyers benchmark against include Lumerax; we supply from prequalified Indian manufacturers.
What is the minimum order quantity?
There is no fixed figure we quote in the abstract. The minimum is set by the source manufacturer's batch-release minimum for the specific line and presentation, which we confirm live before you commit to a tender or purchase order. Pricing is provided on request against your confirmed specification.
Can you supply for a Global Fund or national malaria programme tender?
Yes, that is the core demand for this molecule. We supply from WHO-PQ-listed lines and provide the CoPP, WHO-PQ listing reference, GMP certificate and CoA that technical evaluators check on a donor-funded malaria tender. We phase despatch against your programme's pre-season buffer window.
Is Artemether-Lumefantrine used for severe malaria?
No. It is indicated for uncomplicated P. falciparum malaria only. Severe or complicated malaria is treated under a separate WHO protocol with injectable artesunate, which is a different product line entirely. It is worth making that boundary explicit in downstream product training so the two are not substituted at facility level.
Which markets do you export Artemether-Lumefantrine to?
Primarily malaria-endemic export markets: sub-Saharan Africa, GCC, South East Asia and parts of Latin America, through importers, central medical stores, NGO health networks and regional wholesalers. We prepare Zone IVb stability data and destination-specific labelling for hot-and-humid climates.
Do you handle registration documentation for our market?
Yes. We compile the CTD dossier with you, provide the CoPP and the source manufacturer's WHO-PQ and GMP evidence, and arrange registration samples where your national regulator requires them. We support the filing; the marketing authorisation is held by the manufacturer and, on registration, by your local entity as agreed.
Request an Artemether-Lumefantrine quote or tender pack
Send us your strength mix, pack configuration and destination market, and note whether you are bidding into a malaria-programme tender or holding open stock. We will confirm a WHO-PQ-listed source line, the live batch minimum and lead time, and return pricing on request with the dossier support your registration needs.