Medicines/finished pharmaceutical products

Reference Number: 
MA051

Date of prequalification: 
05 November 2010
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artesunate + Sodium Bicarbonate + Sodium Chloride
Therapeutic area: 
Malaria
Dosage form & strength: 
- (Vial + Ampoule) ; 60mg/vial + 50mg/ml + 45mg/5ml
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Glass Vial (Artesunate powder for Injection) + Glass Ampoule (Sodium bicarbonate Injection): 1x7ml +1x50mg/ml
Applicant: 
Guilin Pharmaceutical Co Ltd, Room 701, N° 780, Cailun Road, Shanghai, 201 203, China (People's Republic of)
FPP Manufacturing Site: 

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

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

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