Artemether & Lumefantrine Tablets

Anti-Malarial · Tablets / Dispersible Tablets · 20/120mg, 40/240mg, 80/480mg

Trade Information

Minimum Order Qty	10,000 tablets
Capacity	100 Million Tablets per month
Strength	20/120mg, 40/240mg, 80/480mg
Private Labelling	Custom branding, artwork & market-specific labelling
Lead Time	45–60 days from order confirmation
Payment Terms	LC at sight, TT (advance / against documents)
Shipping	FOB / CIF to major international ports including Mombasa, Dar es Salaam, Lagos, Douala, Maputo
Pharmacopoeia	BP, USP, IP compliant

Packing Options

Blister (Alu-Alu / Alu-PVC)
Strip pack
Hospital pack
Age-specific colour-coded packs
Custom packing as per buyer requirement

Regulatory & Quality

Registration Status	Registered in multiple African markets. Dossier available for new market registration.
Regulatory Dossiers	CTD / ACTD format dossiers available for submission to national drug authorities.
Stability Data	Zone IVa & IVb stability data available (tropical climate conditions, 30°C/65% RH & 30°C/75% RH)
WHO Prequalification	WHO-GMP Certified

Product Details

Composition	Artemether + Lumefantrine
Dosage Form	Tablets / Dispersible Tablets
Pack Size	1x6, 1x12, 1x18, 1x24 / Custom packing available
Storage	Store below 30°C in a dry place, protected from light and moisture
Shelf Life	24 months from date of manufacture

Description

Artemether-Lumefantrine is a fixed-dose combination antimalarial medicine recommended by the World Health Organization (WHO) as a first-line treatment for uncomplicated Plasmodium falciparum malaria. It is one of the most widely used Artemisinin-based Combination Therapies (ACTs) globally.

BioGalen manufactures Artemether & Lumefantrine Tablets in three strength combinations (20/120mg, 40/240mg, 80/480mg) in both standard and dispersible tablet formulations. The dispersible variants are specifically designed for paediatric use, ensuring accurate dosing and improved compliance in children.

Our AL tablets are a critical product for malaria-endemic regions across Sub-Saharan Africa, Southeast Asia, and Latin America. They are widely procured through government tender programmes, NGO health initiatives, and private sector distribution channels.

Mechanism of Action

Artemether and Lumefantrine act through complementary mechanisms to eliminate Plasmodium parasites. Artemether, a derivative of artemisinin, is rapidly absorbed and converted to its active metabolite dihydroartemisinin (DHA). DHA generates free radicals through interaction with the iron-containing heme molecule inside the parasite, causing oxidative damage to parasite membranes and proteins, leading to rapid parasite clearance within the first 3 days. Lumefantrine works more slowly by interfering with the detoxification of heme within the parasite food vacuole, preventing the conversion of toxic heme into non-toxic hemozoin. This dual mechanism — rapid initial kill by Artemether followed by sustained clearance by Lumefantrine — reduces the risk of recrudescence and delays the development of drug resistance.

Indications

Treatment of uncomplicated Plasmodium falciparum malaria
Mixed malarial infections involving P. falciparum
WHO-recommended first-line ACT therapy
Suitable for adults and children (dispersible tablets for paediatric use)

Available Variants

Artemether 20mg & Lumefantrine 120mg Tablets
Artemether 20mg & Lumefantrine 120mg Dispersible Tablets
Artemether 40mg & Lumefantrine 240mg Tablets
Artemether 40mg & Lumefantrine 240mg Dispersible Tablets
Artemether 80mg & Lumefantrine 480mg Tablets
Artemether 80mg & Lumefantrine 480mg Dispersible Tablets

Frequently Asked Questions

Why is Artemether-Lumefantrine preferred over monotherapy for malaria?

The WHO recommends Artemisinin-based Combination Therapies (ACTs) like Artemether-Lumefantrine over monotherapy to reduce the risk of drug resistance. Artemether provides rapid parasite clearance while Lumefantrine eliminates remaining parasites over a longer period. This two-pronged approach makes it much harder for the Plasmodium parasite to develop resistance compared to single-drug treatment.

What is the difference between standard and dispersible tablet formulations?

Standard tablets are designed for adults and older children who can swallow whole tablets. Dispersible tablets dissolve quickly in a small amount of water to form a suspension, making them ideal for infants and young children (typically 5–25 kg body weight). BioGalen manufactures both formulations across all three strength combinations to serve the full patient population.

How should Artemether-Lumefantrine be administered for best efficacy?

Artemether-Lumefantrine should be taken with food or milk, as Lumefantrine absorption increases significantly (up to 16-fold) with fat intake. The standard regimen is 6 doses over 3 days (at 0, 8, 24, 36, 48, and 60 hours). Completing the full course is critical even if symptoms improve after the first dose.

Is this product suitable for government tender and institutional procurement?

Yes. BioGalen's Artemether-Lumefantrine Tablets are manufactured in a WHO-GMP certified facility with full CTD/ACTD dossiers available. We supply to government malaria control programmes, NGO health initiatives, and institutional buyers across Sub-Saharan Africa and Southeast Asia. Age-specific colour-coded packaging is available for national malaria programmes.

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