Medicines/finished pharmaceutical products

Reference Number: 
MA062

Date of prequalification: 
15 December 2009
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 20mg/120mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
24
Packaging: 
Blister Alu/PVdC/PVC: 6x1, 6x2, 6x3, 6x4, 6x30, 12x30, 18x30, 24x30
Applicant: 
Ipca Laboratories Ltd, Plot No 142, Kandivli Industrial Estate, Kandivli (W), 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
(Artemether) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India
(Artemether) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Lumefantrine) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India