Medicines/finished pharmaceutical products

Reference Number: 
TB354

Date of prequalification: 
22 February 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Levofloxacin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 500mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
24
Packaging: 
Strip, Alu/Alu 10x3
Applicant: 
PT. Kalbe Farma Tbk., Line 8A, Kawasan Industri Delta Silicon, Jl.M.H.Thamrin Blok A3-1, Lippo Cikarang, Bekasi, 17550, Indonesia
FPP Manufacturing Site: 

PT. Kalbe Farma Tbk., Line 8A, Kawasan Industri Delta Silicon, Jl.M.H.Thamrin Blok A3-1, Lippo Cikarang, Bekasi, 17550, Indonesia

API Manufacturing Site: 

(Levofloxacin) Zhejiang Langhua Pharmaceutical Co Ltd, No 7, Donghai 3rd Avenue, Zhejiang Provincial Chemical & Medical Materials Base Linhai Zone, Linhai City, Zhejiang Province, 317 016, China (People's Republic of)