WHO Product ID
MA205
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
Velvet Med-Healthcare Solution S.A
Estrada Nacional 118, Km 38.8, Edifício Mulemba
Benavente,
2130-073
Portugal
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/Aclar
Configuration
6x1, 6x2, 6x3, 6x4, 6x30, 8x3, 12x1, 12x2, 12x30, 18x1, 18x30, 24x1, 24x30
Shelf life (months)
36
Packaging Type
Blister, Alu/PVC/PE/PVdC
Configuration
6x1, 6x2, 6x3, 6x4, 6x30, 8x3, 12x1, 12x2, 12x30, 18x1, 18x30, 24x1, 24x30
Shelf life (months)
48
API Manufacturing Site(s)
By Organization
By Active Ingredient
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India
Artemether, Lumefantrine
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
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)
Macleods Pharmaceuticals Ltd
Unit 2, Phase II, III and IV, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India
Oxalis Labs
Vill. Theda, Baddi, Distt. Solan
P.O.lodhimajra,
174101
India
