Description

Artesunate & Sulfadoxine-Pyrimethamine Tablets

Artesunate & Sulfadoxine-Pyrimethamine Tablets (ACT Combination Kit)

Healthy Life Pharma Private Limited, alongside our specialized global marketing and export division Healthy Inc, is a premier manufacturer, supplier, and exporter of advanced anti-malarial, infectious disease, and public health therapeutics. We manufacture ultra-high-purity, kinetically stable Artesunate & Sulfadoxine-Pyrimethamine ACT Combination Kits in our WHO–GMP certified, high-capacity solid dosage manufacturing facilities. This World Health Organization (WHO) recommended frontline anti-malarial therapy acts as a massive-volume strategic export to National Malaria Control Programs, global humanitarian relief organizations (UNICEF, UNDP, Global Fund), and international B2B distributors across malaria-endemic zones worldwide.

Product Overview

This combination therapy operates as a “Dual-Phase Parasitic Eradication System.” It ensures patient safety and prevents the development of drug resistance by utilizing two completely distinct chemical pathways to clear malaria parasites from the blood.

• Mechanism 1 (Rapid Parasitic Cleavage – Artesunate): Artesunate is an artemisinin derivative that physically reacts with intra-parasitic iron (heme) in the red blood cell. This chemically generates highly reactive free radicals that physically destroy the parasite’s proteins and cell membranes within hours.

• Mechanism 2 (Folate Pathway Blockade – Sulfadoxine): Sulfadoxine physically competes with para-aminobenzoic acid (PABA). This chemically inhibits the enzyme Dihydropteroate Synthetase (DHPS), stopping the first stage of parasitic folate synthesis.

• Mechanism 3 (Nucleic Acid Inhibition – Pyrimethamine): Pyrimethamine physically and chemically blocks Dihydrofolate Reductase (DHFR), the secondary step in folate synthesis. Together with Sulfadoxine, it completely cuts off the parasite’s ability to produce DNA, ensuring the eradication of any remaining biomass.

Product Composition & Kit Configuration

We supply this product in standardized, age-titrated Fixed-Dose Combination (FDC) Blister Strips, commonly containing a 3-day course of Artesunate tablets alongside a single-dose treatment of Sulfadoxine-Pyrimethamine.

Technical & Logistics Specifications

• HS Code: 3004.90.99 (Medicaments acting on parasitic diseases / Anti-malarials)

• CAS Numbers: 88495-63-0 (Artesunate) / 2447-57-6 (Sulfadoxine) / 58-14-0 (Pyrimethamine)

• Dosage Form: Co-packaged Oral Tablets in a Single Blister Strip (ACT Combo Kit)

• Packaging: Customized Patient-Compliance Blisters in high-barrier Alu-Alu (Cold-Form Foil). Our premium packaging configurations protect the moisture-sensitive Artesunate molecules, guaranteeing a 36-month shelf life in Zone IVb high-humidity tropical climates.

Manufacturing Authority & Compliance

• Co-Packaged Compliance Engineering: Malarial recovery fails if patients drop compliance. Our manufacturing lines utilize Specialized Multi-Tablet Blistering Machinery, physically sealing the distinct daily doses of Artesunate and Sulfadoxine-Pyrimethamine into a single, intuitive strip.

• Moisture-Controlled Synthesis Environment: Artesunate is highly physically sensitive to hydrolytic degradation. We maintain strict Dehumidified Production Suites (RH less than 30%), physically ensuring zero moisture uptake during blending, compression, and final foil sealing.

• Validated Dissolution Kinetics: Every batch is chemically verified via Comparative Dissolution Profiling, physically ensuring that the tablets dissolve rapidly in the gastrointestinal tract for fast systemic bioavailability during an acute malarial crisis.

Primary Indications

• Tropical Medicine: First-line treatment of acute, uncomplicated malaria infections caused by Mycobacterium falciparum (or mixed infections).

• Public Health: Deployment in regional mass-treatment health programs where high-efficacy, multi-target anti-malarial therapies are physically required.

Usage Instructions

• The 3-Day Course: Artesunate tablets must be taken physically daily for 3 consecutive days. The Sulfadoxine-Pyrimethamine tablets are typically taken as a single dose on Day 1 alongside the first dose of Artesunate.

• Administration: Swallow tablets physically whole with a glass of water. It is physically ideal to take them with a meal or a milky drink to chemically improve absorption.

• Vomiting Protocol: If the patient physically vomits within 30 minutes of taking a dose, the entire dose must be chemically repeated immediately.

• Adherence Warning: Patients must physically complete the entire 3-day therapy, even if symptoms vanish on Day 2, to chemically prevent a fatal parasitic relapse.

Safety Warning: CRITICAL PUBLIC HEALTH THERAPY. For Confirmed Malaria Diagnosis Only. Sulfonamide Allergy Note: Sulfadoxine is a sulfa drug; it can physically cause severe skin reactions (Stevens-Johnson Syndrome) in sensitive individuals; discontinue immediately if a rash occurs. Pregnancy Note: Avoid use during the first trimester of pregnancy unless alternative treatments are unavailable. Contraindication: Do not use in patients with severe liver or kidney disease, blood dyscrasias, or known hypersensitivity to artemisinin or sulfonamide derivatives.

Global Export & Contract Manufacturing (CDMO Services)

Healthy Life Pharma Private Limited provides fully validated, WHO-GMP compliant Third-Party Contract Manufacturing (CDMO) for Artesunate & Sulfadoxine-Pyrimethamine ACT Combo Kits. Whether you are executing a National Ministry of Health Tender in Sub-Saharan Africa, a humanitarian relief pipeline in SE Asia, or supplying a B2B Pharma Marketplace in South America, we handle all international documentation (COA, COPP, CTD Dossiers) for rapid customs clearance.

Commercial & Bulk Inquiries:

WhatsApp/Call: +91 7710003340

Email: info@healthyinc.co.in