Medicines/finished pharmaceutical products

Reference Number: 
MA100

Date of prequalification: 
16 May 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 40mg/240mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24; 36 (for Alu/Alu blister)
Packaging: 
Alu/PVC/PE/PVdC 12x1; Blister Alu/Alu (desiccant embedded) 12x1; Blister Alu/Alu 12x1; Blister Alu/PVC/Aclar 12x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, 422 113, India

API Manufacturing Site: 

(Lumefantrine) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Artemether) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Artemether) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India
(Lumefantrine) Mylan Laboratories Ltd, Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Parawada (M), Visakhapatnam District, Andhra Pradesh, 531 021, India