Medicines/finished pharmaceutical products

Reference Number: 
MA089

Date of prequalification: 
23 May 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artesunate + Sodium Bicarbonate + Sodium Chloride
Therapeutic area: 
Malaria
Dosage form & strength: 
Artesunate Powder for Injection + Sodium bicarbonate Solvent solution for Injection + Sodium Chloride Solvent Solution for Injection 30mg/vial + 5%m/v + 0.9%m/v
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Glass vial (Artesunate Injection powder) + Glass ampoule (Sodium bicarbonate) + Glass ampoule (Sodium chloride): 30mg/7ml + 0.5ml/ml + 2.5ml/5ml
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, 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)