Medicines/finished pharmaceutical products

Reference Number: 
TB344

Date of prequalification: 
24 January 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Kanamycin (sulfate)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Solution for injection 1000mg/3ml
Storage condition: 
Do not store above 30°C, avoid excursions above 30°C
Shelf life (months): 
18
Packaging: 
Vial, Type I glass 3mlx10
Applicant: 
Mylan Laboratories Limited, Speciality Formulation Facility, No. 19A, Plot No.284-B/1, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, 560105, India
FPP Manufacturing Site: 

Mylan Laboratories Limited, Speciality Formulation Facility, No. 19A, Plot No.284-B/1, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, 560105, India

API Manufacturing Site: 

(Kanamycin (sulfate)) Livzon Group Fuzhou Fuxing Pharmaceutical Co Ltd, Jiangyin Industrial Concentration Zone Fuqing, Fuzhou, Fujian, China (People's Republic of)