Description
Artemether & Lumefantrine Tablets (20mg/120mg & 80mg/480mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Artemether and Lumefantrine Tablets in India. This fixed-dose combination is the World Health Organization (WHO) recommended “Gold Standard” Artemisinin-based Combination Therapy (ACT) for treating uncomplicated P. falciparum malaria. We produce the full range, from Pediatric Dispersible Tablets to the convenient Adult Forte (80/480mg) strength. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and NGO tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Artemether & Lumefantrine Tablets | | Generic Name | Artemether + Lumefantrine USP / IP | | Strength | 20mg/120mg (Standard) / 40mg/240mg / 80mg/480mg (Forte) | | Dosage Form | Uncoated Tablet / Dispersible Tablet (Yellow) | | Standard | USP / IP / WHO Guidelines | | Therapeutic Class | Antimalarial (ACT) | | Shelf Life | 24 – 36 Months | | Packaging | 1×6, 1×12, 1×24 Blister Packs (Course Kits) |
3. Manufacturing Artemether & Lumefantrine Tablets We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Lumefantrine is notoriously difficult to dissolve. To solve this, we use Micronization Technology to reduce the particle size of Lumefantrine, ensuring it can be absorbed even if the patient cannot eat a full fatty meal. For our Pediatric Dispersible Tablets, we use sweetening agents and super-disintegrants to ensure the tablet breaks down in a teaspoon of water in under 60 seconds, making it easy for children to take.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Artemether and Lumefantrine Tablets. We supply National Malaria Control Programs across Africa and Southeast Asia. We provide “Course-of-Therapy” packaging (e.g., 24 tablets for a 3-day adult course) with clear pictorial instructions to ensure patients take the full dose.
4. Quality Assurance We test every batch rigorously.
Dissolution of Lumefantrine: We strictly test that the Lumefantrine releases effectively in simulated gastric fluid.
Related Substances: Artemether is unstable; we monitor for degradation products to ensure the drug remains potent in hot climates.
Assay Ratio: We ensure the precise 1:6 ratio (Artemether to Lumefantrine) is maintained in every tablet for synergistic action.
5. Why Use Artemether & Lumefantrine Tablets? This combination prevents drug resistance and ensures a cure.
Artemether (The Fast Killer): Rapidly reduces the parasite biomass (clears symptoms quickly).
Lumefantrine (The Long Killer): Has a long half-life and eliminates the remaining residual parasites to prevent recurrence (recrudescence).
Key Indications:
Treatment of acute uncomplicated Plasmodium falciparum malaria.
Treatment of malaria in infants, children, and adults.
Effective against Chloroquine-resistant strains.
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF.
7. Frequently Asked Questions
Q: Who manufactures Artemether Lumefantrine Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Do you have the “Forte” strength? A: Yes, we manufacture the 80mg/480mg tablet, which reduces the pill burden for adults (1 tablet instead of 4).
Q: Are the pediatric tablets dispersible? A: Yes, our 20/120mg pediatric tablets are dispersible, sweet-tasting, and easy to mix with water.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Standard Regimen: A 3-day course (total of 6 doses).
Timing: The second dose is taken 8 hours after the first dose. Then, twice daily (morning and evening) for the next 2 days.
Food Effect (Critical): Absorption is significantly improved by food, especially fat (milk, peanut butter, oil). Patients should be encouraged to eat or drink milk with the medication.
9. Side Effects and Precautions
Common Side Effects: Headache, dizziness, anorexia, and palpitations (often similar to malaria symptoms).
QT Prolongation: Lumefantrine can slightly prolong the QT interval. Use caution in patients with cardiac conditions.
Drug Interactions: Avoid use with other drugs that prolong QT interval or CYP3A4 inhibitors (like Ketoconazole).
10. Storage Instructions
Store below 30°C in a dry place.
Protect from light.
Keep out of reach of children.
