Medicines/finished pharmaceutical products

Reference Number: 
MA046

Date of prequalification: 
30 August 2007
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Amodiaquine (hydrochloride) + Artesunate
Therapeutic area: 
Malaria
Dosage form & strength: 
Amodiaquine (Hydrochloride) Tablet + Artesunate Tablet 150mg + 50mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Alu/PVC Co-Blister: (3+3)x1, (6+6)x1, (12+12)x1, (4+4)x3
Applicant: 
Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, 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)) 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)