Medicines/finished pharmaceutical products

Reference Number: 
MA084

Date of prequalification: 
16 November 2012
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Amodiaquine (hydrochloride)/Artesunate
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 135mg/50mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister Alu/PA/Alu/PVC: 3x1
Applicant: 
Guilin Pharmaceutical Co Ltd, No 17 Shanghai Road, Guilin, Guangxi, 541 002, China (People's Republic of)
FPP Manufacturing Site: 

Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of)

API Manufacturing Site: 

(Amodiaquine (hydrochloride)) Ipca Laboratories Ltd, 89A-B, 90/91 Industrial Estate, Pologround, Indore, Madhya Pradesh, India
(Amodiaquine (hydrochloride)) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Artesunate) Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of)