Product Details
WHO Product ID
MA167
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet 20mg/120mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Laboratorios Basi - Industria Farmaceutica SA
Parque Industrial de Mortagua, Lotes 8, 15, 16
Mortagua,
3450-232
Portugal
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVDC
Configuration
1x6, 2x6, 3x6, 4x6, 30x1x6, 30x1x12, 30x1x18, 30x1x24, 30x6, 30x12, 30x18, 30x24
Shelf life (months)
24
Storage conditions
Do not store above 30°C, store in the original container, protect from light
Packaging Type
Blister, Alu/PVDC/PVC
Configuration
1x6, 2x6, 3x6, 4x6, 30x1x6, 30x1x12, 30x1x18, 30x1x24, 30x6, 30x12, 30x18, 30x24
Shelf life (months)
24
Storage conditions
Do not store above 30°C, store in the original container, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India
Artemether, Lumefantrine
Mangalam Drugs and Organics Limited
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Artemether, Lumefantrine
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Artemether, Lumefantrine
FPP Manufacturing Site(s)
Ipca Laboratories Ltd
Plot No 255/1, Village Athal
Silvassa,
Dadra and Nagar Haveli
Daman and Diu 396230
India