Product Details
WHO Product ID
MA092
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Applicant organization
Ajanta Pharma Ltd
Ajanta House, Charkop, Kandivli (W)
Mumbai,
400 067
India
Packaging details and storage conditions
Packaging Type
Blister, Al/PVdC/PVC
Configuration
6x1, 12x1; 6x30, 12x30
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
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
Solara Active Pharma Sciences Ltd
120 A & B, 36, 120P & 121 Industrial Area, Baikampady
New Mangalore,
Karnataka
575 011
India
Artemether, Lumefantrine
FPP Manufacturing Site(s)
Ajanta Pharma Limited
Z/103/A, Dahej SEZ-II, Bharuch
Gujarat
392130
India
Ajanta Pharma Ltd
B4/5/6 MIDC Industrial Area, Paithan District
Chhatrapati Sambhajinagar,
Maharashtra
431 148
India