WHO-GMP Certified Commercial Pack · Product Code: AKP-030-MAL
Artemether 80 mg & Lumefantrine 480 mg Tablets
Formulation Overview: WHO-recommended 3-day fixed-dose artemisinin-based combination therapy (ACT) pairing fast-acting artemether 80 mg parasite clearance with long-acting lumefantrine 480 mg recrudescence prevention. Formulated with Artemether 80 mg + Lumefantrine 480 mg (80 mg + 480 mg) in Film-Coated Tablets dosage form under Antimalarials Medication, manufactured to IP / BP / USP Compendial standards and supplied in 10 x 6 Alu-Alu / Blister Pack with complete eCTD/ACTD regulatory dossiers, Zone IVb stability, and batch CoA for African NRAs (NAFDAC, PPB, SAHPRA, TMDA, FDA Ghana) and global tenders.
| Item Code (SKU) | AKP-030-MAL |
|---|---|
| Catalog Reference | AKP-030-MAL · SN 30 |
| Therapeutic Sector | Antimalarials Medication |
| Dosage Form | Film-Coated Tablets |
| Active Ingredient | Artemether 80 mg + Lumefantrine 480 mg |
| Strength / Purity | 80 mg + 480 mg |
| Clinical Indication | First-line oral treatment of acute uncomplicated Plasmodium falciparum malaria (including multidrug-resistant strains) |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 10 x 6 Alu-Alu / Blister Pack |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C in a dry place, protect from light and moisture |
| Minimum Order Quantity | 1000 Packs |
| Regulatory / Analytical Docs | Full eCTD / ACTD Modules 1–5 + Zone IVb Stability Available |
| African & Global NRA Readiness | NAFDAC (Nigeria), PPB (Kenya), SAHPRA (SA), TMDA (Tanzania), FDA Ghana, AIRP, ARP, EFDA |
| Stock Availability | In Stock · Immediate Commercial Dispatch |
| Supply Status | Commercial Export Ready |