Description
Artesunate & Sulphadoxine-Pyrimethamine Tablets (ACT Combo)
Healthy Inc is a premier global supplier of high-efficacy antimalarial therapies. We provide premium Artesunate + Sulphadoxine + Pyrimethamine combination packs, manufactured in WHO–GMP certified specialized anti-infective units. As a first-line treatment for uncomplicated Plasmodium falciparum malaria, this product is a critical export for tropical medicine clinics, NGO health missions, and Ministry of Health (MOH) tenders in Africa and Southeast Asia.
Product Overview
This therapeutic regimen combines the rapid schizonticidal action of Artesunate with the sustained parasitic clearance of the Sulphadoxine-Pyrimethamine (SP) duo. It is specifically engineered to achieve rapid clinical cure and delay the development of drug resistance.
The “Resistance-Busting” Antimalarial Specialist:
- Synergistic Mechanism: Artesunate (an Artemisinin derivative) produces free radicals upon reacting with parasite heme, causing rapid reduction of the parasite biomass. Sulphadoxine and Pyrimethamine then act as antifolates, inhibiting the dihydropteroate synthase and dihydrofolate reductase enzymes respectively, ensuring the elimination of residual parasites.
- WHO Recommended Protocol: This combination follows the World Health Organization’s guidelines for Artemisinin-based Combination Therapy (ACT), providing a 3-day treatment course for maximum efficacy.
- Gameticidal Activity: Artesunate possesses potent activity against the sexual stages (gametocytes) of the parasite, thereby reducing the transmission potential of malaria within the community.
Technical & Manufacturing Specifications
Formulated for absolute stability and patient-friendly compliance (Co-blistered or FDC).
| Technical Metric | Specification Standard |
|---|---|
| Active Ingredients | Artesunate (AS) + Sulphadoxine (S) + Pyrimethamine (P) |
| Dosage Form | Co-blistered Tablets / Fixed-Dose Combination (FDC) |
| Standard Strengths | AS 50/100/200 mg + (S 500 mg / P 25 mg) |
| HS Code | 3004.20.91 (Antimalarials) / 3004.90.99 |
| Packaging | Tropical Grade Alu-Alu Blister (Imperative for Artesunate stability) |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified facilities.
- Moisture Sensitivity Control: Artesunate is highly unstable in humid conditions. Our manufacturing process involves low-humidity (RH < 30%) containment and the use of specialized moisture-scavenging excipients to prevent degradation.
- Patient Compliance Engineering: We utilize color-coded blisters and clear iconography to ensure patients correctly follow the 3-day dosing schedule, which is critical for preventing treatment failure and resistance.
- Stability Validation: Validated for Climatic Zone IVb. Our formulation ensures that the labile endoperoxide bridge of Artesunate remains intact for 24–36 months in sub-Saharan and tropical Asian environments.
Therapeutic Indications & Clinical Symptoms
- Uncomplicated P. falciparum Malaria: Treatment of patients exhibiting fever, chills, and headache with confirmed parasitic presence.
- Malarial Crisis Management: Rapid reduction of parasite load in areas with known resistance to chloroquine or SP monotherapy.
- Epidemic Control: Used in mass drug administration (MDA) programs during malarial outbreaks.
Dosage & Administration
- Artesunate: Typically administered once daily for 3 consecutive days.
- Sulphadoxine-Pyrimethamine: Usually administered as a single dose on the first day of treatment.
- Administration: Should be taken with food (preferably containing fats) to enhance absorption.
- Safety Note: Contraindicated in patients with severe sulfonamide allergy. Not recommended for use in the first trimester of pregnancy unless no other alternative is available.
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Global Health NGOs and National Malaria Control Programs. We offer Third Party Manufacturing for AS+SP with full CTD Dossier and COPP support. Our logistics network ensures secure transit to Nigeria, Ghana, Vietnam, and the DRC, providing WHO-GMP quality at competitive B2B prices.
