Description
Artesunate and Amodiaquine Tablets (ACT)
Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)
1. Product Introduction
Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Artesunate and Amodiaquine Tablets in India. This Artemisinin-based Combination Therapy (ACT) is a vital antimalarial medication recommended by the World Health Organization (WHO) for the treatment of uncomplicated Plasmodium falciparum malaria. It is particularly widely used in West and Central Africa.
We offer Contract Manufacturing (Third Party) services for this chemically complex formulation. Because Artesunate and Amodiaquine are chemically incompatible if mixed directly (leading to rapid degradation), we utilize advanced Bilayer Tablet Technology or Co-Blistered Combi-Packs to ensure stability. Our WHO-GMP certified facility in Mumbai supplies National Malaria Control Programs (NMCP) and NGOs with high-stability formulations suited for tropical climates.
2. Product Specifications
| Parameter | Specification |
| Product Name | Artesunate and Amodiaquine Tablets |
| Generic Name | Artesunate & Amodiaquine Hydrochloride Tablets USP / BP / IP |
| CAS Number | 88495-63-0 (Artesunate) / 6398-98-7 (Amodiaquine) |
| Strength | Infant: Artesunate 25mg + Amodiaquine 67.5mg
Toddler: Artesunate 50mg + Amodiaquine 135mg
Adult: Artesunate 100mg + Amodiaquine 270mg |
| Dosage Form | Bilayer Tablet (FDC) / Co-Blistered Tablets |
| Standard | USP / BP / IP / WHO Compliant |
| Therapeutic Class | Antimalarial / ACT |
| Shelf Life | 24 to 36 Months |
| Packaging | 1×3, 1×6, or 25×3 Blisters (Alu-Alu) |
3. Manufacturing Technology
Overcoming chemical incompatibility is the key to a quality ACT.
The Manufacturer: Healthy Life Pharma Pvt. Ltd.
Bilayer Technology: We frequently manufacture this as a Bilayer Tablet. One layer contains Artesunate and the other contains Amodiaquine. This physical separation within the same tablet prevents the acidic Amodiaquine from degrading the acid-sensitive Artesunate, ensuring a shelf-stable product.
Moisture Protection: Artesunate is highly susceptible to hydrolysis (breakdown by water). We manufacture in Low-Humidity Suites (< 30% RH) and use moisture-protective coating agents.
Taste Masking: Amodiaquine is bitter. We use sweetening agents and flavors in pediatric dispersible formulations to improve compliance in children.
The Exporter: Healthy Inc
Tropical Packaging: We use Alu-Alu Cold Form Blisters exclusively for this product. This provides a near-perfect barrier against humidity and light, which is essential for preserving the potency of Artesunate during transport to malaria-endemic regions.
4. Quality Assurance
We adhere to strict Pharmacopoeial and WHO protocols:
Dissolution: We test the release rate of both drugs. Artesunate must release immediately to lower the parasite load, while Amodiaquine releases to clear residual parasites.
Degradation Products: We strictly monitor for Dihydroartemisinin (an impurity of Artesunate) and Amodiaquine impurities to ensure the drug remains safe and effective.
Microbial Limits: Strict bioburden testing ensures patient safety.
5. Why Use Artesunate + Amodiaquine?
It is a potent weapon against drug-resistant malaria.
Mechanism:
Artesunate: Rapidly reduces the parasite biomass (kills 99% of parasites within 24 hours).
Amodiaquine: Has a longer half-life and eliminates remaining parasites to prevent recrudescence (return of the infection).
Key Indications:
Uncomplicated Malaria: First-line treatment for P. falciparum malaria in many countries.
Seasonal Malaria Chemoprevention (SMC): Used in combination with SP for prevention in children during rainy seasons.
6. Export and Regulatory Support
We streamline the registration process for our B2B partners:
Dossier Support: We offer CTD and ACTD Dossiers for quick registration.
Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.
Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).
7. Frequently Asked Questions
Q: Who manufactures Artesunate Amodiaquine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using stability-enhanced bilayer technology.
Q: Is this better than Artemether-Lumefantrine?
A: Both are excellent ACTs. The choice depends on the specific resistance patterns in the local area (National Malaria Treatment Guidelines).
Q: Can I take this on an empty stomach?
A: It is generally recommended to take it with food or milk to increase absorption and reduce stomach upset.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION
(For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Standard Course: Taken once daily for 3 days.
Dosing by Weight:
4.5 to <9 kg: 1 tablet (25/67.5mg) daily.
9 to <18 kg: 1 tablet (50/135mg) daily.
18 to <36 kg: 1 tablet (100/270mg) daily.
36 kg (Adult): 2 tablets (100/270mg) daily.
Administration: Tablets for children can be crushed and mixed with water or milk just before administration.
9. Side Effects and Precautions
Common Side Effects: Abdominal pain, nausea, vomiting, weakness, and dizziness.
Liver Function: Rare cases of hepatotoxicity have been reported; monitor if jaundice appears.
Neurological: Amodiaquine can cause involuntary movements (extrapyramidal effects) in rare cases.
Pregnancy: Generally considered safe in the 2nd and 3rd trimesters; benefit usually outweighs risk in the 1st trimester if no other option is available.
10. Storage Instructions
Store below 30°C in a dry place.
Keep strictly protected from light and moisture.
