Medicines/finished pharmaceutical products

Reference Number: 
MA136

Date of prequalification: 
19 June 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet, Dispersible 20mg/120mg
Storage condition: 
Alu/Alu blister: Do not store above 30°C; PVC/PCTFE/PVC/Alu blister: Do not store above 30°C. Protect from light. Store tablets in blisters in the provided cartons
Shelf life (months): 
24
Packaging: 
Blister, PVC/PCTFE/PVC/Alu 6x1, 12x1, 6x30, 12x30; Blister, Alu/Alu 6x1, 12x1, 6x30, 12x30,
Applicant: 
Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India
FPP Manufacturing Site: 

Ipca Laboratories Ltd, Plot No 255/1, Village Athal, Silvassa, Dadra & Nagar Haveli (Union Territory), 396 230, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Artemether) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India
(Lumefantrine) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India