WHO Product ID
MA211
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
Quality Chemical Industries Limited
Plot 1-7, 1st Ring Road, Luzira Industrial Park, P.O. Box 34871
Kampala,
Hebei
52560
Uganda
Packaging details and storage conditions
Packaging Type
Blister, Alu/Aclar PVC
Configuration
6x1, 6x30, 12x1, 12x30, 18x1,18x30, 24x1, 24x30
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
Condition
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mangalam Drugs and Organics Limited
Unit 1, Plot No 187, 2nd Phase, GIDC
Vapi, Valsad,
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
Shanghai Desano Chemical Pharmaceutical Co., Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Artemether, Lumefantrine
FPP Manufacturing Site(s)
Quality Chemical Industries Limited
Plot 1-7, 1st Ring Road, Luzira Industrial Park, P.O. Box 34871
Kampala,
Uganda