Medicines/finished pharmaceutical products

Reference Number: 
MA116

Date of prequalification: 
21 August 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride)
Therapeutic area: 
Malaria
Dosage form & strength: 
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) dispersible tablets 12.5mg/250mg + 76.5mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
24
Packaging: 
Blister Alu/PVC (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)) 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
(Pyrimethamine) Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of)
(Sulfadoxine) Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of)