Artesunate & Amodiaquine Tablets

Artesunate & Amodiaquine Tablets (ACT Combination)

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 & Amodiaquine Tablets in our WHO–GMP certified, high-capacity solid dosage manufacturing facilities. This frontline Artemisinin-based Combination Therapy (ACT) serves as a high-volume strategic export to National Malaria Control Programs, humanitarian relief agencies (UNICEF, Global Fund), and international B2B wholesale distributors across malaria-endemic zones globally.

Product Overview

This formulation operates as a “Dual-Action Schizontocidal System.” It ensures patient safety and prevents the development of drug-resistant strains by combining a fast-acting artemisinin derivative with a long-acting 4-aminoquinoline partner.

• Mechanism 1 (Rapid Oxidative Stress – Artesunate): Artesunate physically reacts with intra-parasitic heme iron inside the infected red blood cells. This chemically generates highly reactive free radicals that physically disrupt the parasite’s food vacuole and cell membranes, halting replication within hours.

• Mechanism 2 (Heme Polymerization Inhibition – Amodiaquine): Amodiaquine physically accumulates within the acidic food vacuole of the malaria parasite. It chemically binds to toxic free heme, physically preventing its conversion into harmless hemozoin blocks. The resulting accumulation of free heme is chemically toxic, destroying the parasite from within.

• Mechanism 3 (Synchronized Clearance): Artesunate handles the rapid physical reduction of the initial parasitic biomass, while Amodiaquine maintains a chemically active therapeutic window over several days to ensure complete parasitic elimination.

Product Composition & Available Strengths

We supply this product in both modern co-formulated Fixed-Dose Combination (FDC) single tablets and customized co-blistered kits, accurately titrated for adult and pediatric compliance.

Technical & Logistics Specifications

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

• CAS Numbers: 88495-63-0 (Artesunate) / 86-42-0 (Amodiaquine)

• Dosage Form: Oral Fixed-Dose Combination (FDC) Tablet

• Packaging: 3-Day Compliance Blisters sealed in high-barrier Alu-Alu (Cold-Form Foil). Our premium packaging configurations protect the moisture-sensitive artemisinin structure, ensuring a 36-month shelf life in Zone IVb tropical environments.

Manufacturing Authority & Compliance

• Dehumidified Multi-API Granulation: Artesunate is highly physically sensitive to moisture-driven hydrolytic degradation, while Amodiaquine exhibits high chemical stability. We run our processing lines in specialized Dehumidified Cleanrooms (Relative Humidity less than 30%) to physically ensure zero moisture entrapment during compression.

• Precision Dose Uniformity: Because under-dosing directly breeds global parasitic resistance, our automated high-speed compression matrices physically verify that the exact micro-gram balance of Artesunate to Amodiaquine is chemically maintained across every single batch.

• Comparative Dissolution Verification: Every export batch physically undergoes Automated Dissolution Profiling, chemically ensuring that both active pharmaceutical ingredients (APIs) dissolve rapidly for immediate absorption during an acute malarial crisis.

Primary Indications

• Tropical Medicine: First-line treatment of acute, uncomplicated malaria infections caused by Plasmodium falciparum (including multi-drug resistant strains).

• Public Health: Large-scale institutional distribution for regional malaria eradication and epidemic management.

Usage Instructions

• The 3-Day Protocol: The medication must be taken physically once daily for 3 consecutive days.

• Administration: Swallow tablets physically whole with a glass of water. Taking the dose with food can chemically reduce the incidence of mild, transient nausea associated with amodiaquine.

• Strict Adherence: It is physically vital that the patient completes the entire 3-day regimen, even if clinical symptoms disappear on Day 2, to chemically prevent a recrudescence (relapse) of the parasite.

• Vomiting Rule: If the patient physically vomits within 30 minutes of consumption, the entire daily dose must be chemically repeated immediately.

Safety Warning: CRITICAL ANTICIPATED MALARIA THERAPY. For Confirmed Parasitic Diagnosis Only. Hepatic Note: Amodiaquine can rarely chemically cause transient liver enzyme elevation; monitor physically if used repeatedly. Neurological Note: Use with physical caution in patients with a history of seizures or severe neurological disorders. Contraindication: Do not use in patients with severe hepatic impairment, history of agranulocytosis, or known hypersensitivity to artemisinin or aminoquinoline derivatives.

Global Export & Contract Manufacturing (CDMO Services)

Healthy Life Pharma Private Limited provides comprehensive, fully validated Third-Party Contract Manufacturing (CDMO) for Artesunate & Amodiaquine FDC Tablets. Whether you are bidding for a National Ministry of Health Tender in West Africa, executing an emergency relief pipeline in SE Asia, or stocking an international B2B Pharma Marketplace, we prepare all required international registration dossiers (COA, COPP, CTD Format Dossiers) for rapid customs clearance.

Commercial & Bulk Inquiries:

WhatsApp/Call: +91 7710003340

Email: info@healthyinc.co.in