Sulfadoxine & Pyrimethamine Tablets

Anti-Malarial · Tablets · 500mg / 25mg

Trade Information

Minimum Order Qty	1,000,000 tablets
Capacity	100 Million Tablets per month
Strength	500mg / 25mg
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 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	Sulfadoxine 500mg + Pyrimethamine 25mg
Dosage Form	Tablets
Pack Size	1x3, 10x3, Blister of 3 / Custom packing available
Storage	Store below 30°C in a dry place, protected from light
Shelf Life	36 months from date of manufacture

Description

Sulfadoxine-Pyrimethamine (SP) is a fixed-dose antimalarial combination widely used for Intermittent Preventive Treatment in pregnancy (IPTp) and Seasonal Malaria Chemoprevention (SMC) in children. It is listed on the WHO Model List of Essential Medicines.

SP works by inhibiting two enzymes in the folate synthesis pathway of the malaria parasite, providing a synergistic antimalarial effect. It remains a cornerstone of malaria prevention programmes across Sub-Saharan Africa, where it is distributed through antenatal care clinics and community health programmes.

BioGalen manufactures Sulfadoxine 500mg & Pyrimethamine 25mg Tablets for bulk export. Our SP tablets are widely procured by government health ministries, NGOs, and international health organisations for malaria prevention programmes.

Mechanism of Action

Sulfadoxine and Pyrimethamine act synergistically by sequentially blocking two different enzymes in the folate biosynthesis pathway of the Plasmodium parasite. Sulfadoxine is a structural analogue of para-aminobenzoic acid (PABA) that competitively inhibits dihydropteroate synthase (DHPS), the enzyme that catalyses the first step of folate synthesis. Pyrimethamine inhibits dihydrofolate reductase (DHFR), the enzyme responsible for the second step — converting dihydrofolate to tetrahydrofolate. By blocking two sequential steps in the same metabolic pathway, the combination produces a synergistic antiparasitic effect that is far more potent than either drug alone. Both drugs have long half-lives (Sulfadoxine ~7–9 days, Pyrimethamine ~3–4 days), which enables single-dose treatment and makes SP uniquely suited for intermittent preventive therapy programmes.

Indications

Intermittent Preventive Treatment in pregnancy (IPTp)
Seasonal Malaria Chemoprevention (SMC) in children
Treatment of uncomplicated P. falciparum malaria (in combination with other antimalarials)
Malaria prophylaxis in endemic areas

Available Variants

Sulfadoxine 500mg & Pyrimethamine 25mg Tablets

Frequently Asked Questions

Why is SP the standard drug for malaria prevention in pregnancy?

The WHO recommends SP for Intermittent Preventive Treatment in pregnancy (IPTp) because its long half-life allows single-dose administration at each antenatal care visit, eliminating the need for multi-day courses. SP has an established safety profile in the second and third trimesters and is the only antimalarial currently recommended by WHO for routine preventive use in pregnancy. It is administered at every scheduled antenatal visit from the second trimester onwards.

What is the role of SP in Seasonal Malaria Chemoprevention (SMC)?

In the Sahel and sub-Sahel regions of Africa, SP is combined with Amodiaquine for SMC — a WHO-recommended strategy where children aged 3–59 months receive monthly treatment courses during the peak malaria transmission season. SP provides long-acting prophylaxis while Amodiaquine provides rapid parasite clearance. This is one of the highest-volume procurement programmes for SP globally.

What pack configurations are used for government malaria programmes?

For IPTp programmes, SP is typically supplied in blister packs of 3 tablets (single treatment dose). For SMC programmes, it is packed alongside Amodiaquine in age-specific co-blister packs. BioGalen supplies both standard blister packs (1x3, 10x3) and can produce custom co-blister configurations for programme-specific requirements.

Is there growing resistance to SP and does it affect procurement demand?

DHFR/DHPS mutations have reduced SP efficacy for malaria treatment in parts of East Africa, which is why SP is no longer recommended as a first-line treatment in most countries. However, WHO continues to strongly recommend SP for IPTp and SMC prevention programmes even in areas with moderate resistance, as it retains protective efficacy in these preventive contexts. Procurement demand for SP remains high and stable across Sub-Saharan Africa.

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