WHO Product ID
MA210
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet 80mg/480mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Velvet Med-Healthcare Solutions S.A
Estrada Nacional 118, Km 38.8, Edifício Mulemba
Benavente,
2130-073
Portugal
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PE/PVdC
Configuration
6x1, 6x30, 15x10
Shelf life (months)
36
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
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)
Oxalis Labs
Vill. Theda, Baddi, Distt. Solan
P.O.lodhimajra,
174101
India
