Artemether + Lumefantrine Tablet Generics - Manufacturers & Suppliers
Coartem(EU)
| Product/Composition:- | Artemether + Lumefantrine tablet |
|---|---|
| Strength:- | 20 mg/120 mg per tablet |
| Form:- | Tablet |
| Reference Brands:- | Coartem(EU) |
| MOQ | As per the manufacturer batch size |
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Artemether–Lumefantrine inhibits Plasmodium falciparum by disrupting parasite DNA and calcium homeostasis, leading to parasite death. It effectively treats uncomplicated malaria, offering rapid symptom relief, high cure rates, and convenient oral dosing. Its combination prevents resistance development, making it a preferred first-line therapy in endemic regions.
Artemether + Lumefantrine tablets, marketed as Coartem, are approved in some EU countries for uncomplicated Plasmodium falciparum malaria. In the EU, brands are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards, though approval status varies. In the US, the combination is not approved for malaria treatment, but importation for travel use is permitted. Both regions require detailed dossiers, clinical trial data, quality assurance, and pharmacovigilance plans for approval and ongoing safety monitoring. For expert regulatory support, dossier preparation, and compliance, visit PharmaTradz. We facilitate seamless market access, ensuring adherence to European and US standards for safe, effective malaria therapy.