Medicines/finished pharmaceutical products

Reference Number: 
TB319

Date of prequalification: 
11 May 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Amikacin (sulfate)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Solution for injection 500mg
Storage condition: 
Do not store above 30°C, avoid excursions above 30°C
Shelf life (months): 
18
Packaging: 
Ampoule, Type I glass 2ml 10x1
Applicant: 
Qilu Pharmaceutical Co.,Ltd, No. 243 Gong Ye Bei Road, Jinan, Shandong, 250100, China (People's Republic of)
FPP Manufacturing Site: 

Qilu Pharmaceutical Co., Ltd., No. 317, Xinluo Road, High-tech Zone, Jinan, Shandong, 250101, China (People's Republic of)

API Manufacturing Site: 

(Amikacin (sulfate)) Qilu Tianhe Pharmaceuticals Co Ltd, No 849 Dongjia Town, Licheng District, Jinan, Shandong, 250 105, China (People's Republic of)