Artesunate Tablets

Anti-Malarial · Tablets · 50mg / 100mg

Trade Information

Minimum Order Qty	1,000,000 tablets
Capacity	100 Million Tablets per month
Strength	50mg / 100mg
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, Durban, Manila, Phnom Penh
Pharmacopoeia	BP, USP, IP compliant

Packing Options

Blister (Alu-Alu / Alu-PVC)
Strip pack
Hospital bulk pack
Custom packing as per buyer requirement

Regulatory & Quality

Registration Status	Registered in multiple African and Asian 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	Artesunate
Dosage Form	Tablets
Pack Size	1x6, 1x12, 10x6 / 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

Artesunate is a fast-acting artemisinin derivative used in the treatment of malaria. It is recommended by the WHO as a key component of Artemisinin-based Combination Therapies (ACTs) and is listed on the WHO Model List of Essential Medicines.

Artesunate acts rapidly to reduce parasite load, making it critical in the early treatment of both uncomplicated and severe malaria. It is widely used across Sub-Saharan Africa and Southeast Asia where P. falciparum malaria is endemic.

BioGalen manufactures Artesunate Tablets in 50mg and 100mg strengths, as well as injectable formulations (60mg, 120mg, 180mg) for severe malaria cases. Our products are available for government tender procurement, NGO health programmes, and private sector distribution.

Mechanism of Action

Artesunate is a water-soluble hemisuccinate derivative of artemisinin that is rapidly hydrolysed in vivo to its active metabolite dihydroartemisinin (DHA). DHA contains an endoperoxide bridge that reacts with intracellular iron (Fe²⁺) — particularly the iron released from haemoglobin digestion inside the parasite food vacuole — to generate highly reactive carbon-centred free radicals. These free radicals alkylate and damage multiple parasite proteins, lipids, and membranes, causing rapid and irreversible parasite death. Artesunate has the fastest parasite clearance time of any antimalarial drug, reducing parasite biomass by approximately 10,000-fold per 48-hour asexual cycle. It is active against all erythrocytic stages of P. falciparum including young ring-stage parasites, which is critical for preventing progression to severe disease.

Indications

Treatment of uncomplicated Plasmodium falciparum malaria (as part of ACT)
Initial treatment of severe malaria (oral follow-up after injectable artesunate)
Mixed malarial infections
Malaria in endemic regions of Africa, Asia, and Latin America

Available Variants

Artesunate Tablets 50mg
Artesunate Tablets 100mg
Artesunate 60mg Injection
Artesunate 120mg Injection
Artesunate 180mg Injection

Frequently Asked Questions

Why is Artesunate never used as monotherapy?

The WHO strictly recommends against artemisinin monotherapy to prevent the development of drug resistance. Artesunate clears parasites rapidly but has a very short half-life (approximately 1 hour). If used alone, residual parasites surviving after drug clearance can develop resistance. In combination with a longer-acting partner drug (Amodiaquine, Lumefantrine, or Mefloquine), the partner drug eliminates remaining parasites. Oral Artesunate monotherapy is reserved only for initial treatment before a full ACT course.

What is the difference between oral and injectable Artesunate?

Oral Artesunate (50mg/100mg tablets) is used as a component of ACT for uncomplicated malaria. Injectable Artesunate (60mg, 120mg, 180mg) is the WHO-recommended first-line treatment for severe malaria, replacing injectable Quinine. BioGalen manufactures both formulations, allowing health systems to source their complete Artesunate supply chain from a single manufacturer.

What are the key procurement considerations for Artesunate?

Artesunate is a WHO Essential Medicine with strong demand from government malaria programmes, Global Fund-supported procurement, and NGO health initiatives. Key buyer considerations include WHO-GMP certification, Zone IVa/IVb stability data (critical for tropical supply chains), availability of multiple strengths, and the ability to supply both oral and injectable forms. BioGalen meets all these requirements.

How should Artesunate Tablets be stored in tropical climates?

Artesunate Tablets should be stored below 30°C, protected from light and moisture. BioGalen provides Zone IVa and IVb stability data demonstrating product integrity under accelerated tropical conditions (30°C/65% RH and 30°C/75% RH). Our Alu-Alu blister packaging provides superior moisture protection compared to PVC blisters, which is particularly important for markets with high ambient humidity.

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