Product Details
WHO Product ID
MA136
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
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
6x1, 12x1, 6x30, 12x30
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Blister, PVC/PCTFE/PVC/Alu
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
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India
Artemether, Lumefantrine
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Lumefantrine
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Lumefantrine
FPP Manufacturing Site(s)
Ipca Laboratories Limited
1 Pharma Zone, SEZ Indore
Pithampur,
Madhya Pradesh
454775
India
Ipca Laboratories Ltd
Plot No 255/1, Village Athal
Silvassa,
Dadra and Nagar Haveli
Daman and Diu 396230
India