Product Details
WHO Product ID
MA091
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
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Blister, Al/PVC/Aclar
Configuration
6x1, 6x2, 6x3, 6x4, 6x30, 8x3, 12x1, 12x2, 12x30, 18x1, 18x30, 24x1, 24x30
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
Packaging Type
Blister, Al/PVC/PE/PVdC
Configuration
6x1, 6x2, 6x3, 6x4, 6x30, 8x3, 12x1, 12x2, 12x30, 18x1, 18x30, 24x1, 24x30
Shelf life (months)
48
Storage conditions
Do not store above 30°C, protect from light
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 & Organics Ltd
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