Medicines/finished pharmaceutical products

Reference Number: 
MA098

Date of prequalification: 
20 October 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride)
Therapeutic area: 
Malaria
Dosage form & strength: 
Pyrimethamine/Sulfadoxine Tablets + Amodiaquine (hydrochloride) Film coated Tablets 25mg/500mg + 150mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Alu/PVC Co-blister: (1+3)x25, (1+3)x50
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
(Pyrimethamine) Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of)