Description
Sulfadoxine & Pyrimethamine Tablets (500 mg / 25 mg)
Healthy Inc is a specialized global supplier of high-stability antimalarial therapies. We provide premium Sulfadoxine & Pyrimethamine Tablets, manufactured in WHO–GMP certified facilities. As a primary tool for the prevention and treatment of malaria, this product is a cornerstone export for National Malaria Control Programs (NMCP), maternal health clinics, and Ministry of Health (MOH) tenders across Sub-Saharan Africa and Southeast Asia.
Product Overview
Sulfadoxine & Pyrimethamine (SP) is a fixed-dose combination of two antifolate agents. It is specifically engineered to provide a sequential blockade of the folic acid synthesis pathway in malaria parasites, leading to a potent synergistic effect.
The “Antifolate Synergy” Specialist:
- Mechanism of Action: Sulfadoxine acts as a competitive inhibitor of dihydropteroate synthase (DHPS), while Pyrimethamine inhibits dihydrofolate reductase (DHFR). By blocking these two consecutive steps, the combination prevents the parasite from synthesizing the folates required for DNA and RNA production.
- Long-Acting Protection: Due to the exceptionally long half-lives of both components (Sulfadoxine ~150-200 hours; Pyrimethamine ~80-100 hours), a single dose provides several weeks of therapeutic coverage, making it ideal for preventative strategies.
- Maternal & Child Health: SP is the WHO-recommended standard for Intermittent Preventive Treatment in pregnancy (IPTp) and Seasonal Malaria Chemoprevention (SMC) in infants, significantly reducing the incidence of low birth weight and maternal anemia.
Technical & Manufacturing Specifications
Formulated for rapid bioavailability and stability in tropical environments.
| Technical Metric | Specification Standard |
|---|---|
| Active Composition | Sulfadoxine (500 mg) + Pyrimethamine (25 mg) |
| Dosage Form | Uncoated or Film-Coated Tablets |
| HS Code | 3004.20.19 (Antimalarial Medicaments) / 3004.90.99 |
| Packaging | Alu-Alu Blister (Crucial for high-humidity protection) |
| Regulatory Status | WHO-GMP, CTD Dossier, COPP Available for NGO Tenders |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from specialized ISO 9001:2015 units.
- Tropical Zone Stability: Manufactured and validated for Climatic Zone IVb (40°C / 75% RH). Our formulation utilizes specialized moisture-barrier excipients to prevent degradation in extreme heat and humidity.
- Precision Dosing: Given the low dose of Pyrimethamine (25 mg) relative to Sulfadoxine (500 mg), we utilize validated high-precision blending to ensure perfect content uniformity across every tablet.
- Bioequivalence: Every batch is tested against the innovator brand (Fansidar) using multi-point dissolution profiles to ensure consistent clinical outcomes.
Therapeutic Indications & Clinical Symptoms
- Treatment of Uncomplicated Malaria: Management of P. falciparum malaria in areas where the parasite remains susceptible.
- IPTp (Intermittent Preventive Treatment): Prevention of malaria in pregnant women to protect both maternal and fetal health.
- SMC (Seasonal Malaria Chemoprevention): Used in combination with Amodiaquine for the prevention of malaria in children during high-transmission seasons.
Dosage & Administration
- Standard Adult Dose: 3 tablets taken as a single dose.
- Administration: Should be taken with plenty of water. It can be taken with or without food.
- Safety Note: Contraindicated in patients with severe renal or hepatic insufficiency or known hypersensitivity to sulfonamides.
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to The Global Fund, UNICEF, and Ministry of Health Tenders. We offer Third Party Manufacturing for Sulfadoxine & Pyrimethamine with full CTD Dossier support. Our logistics network ensures secure, high-volume supply to Nigeria, Ghana, Kenya, and the Democratic Republic of Congo, providing WHO-GMP quality at competitive B2B prices.
Commercial Inquiries
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
