Product details
WHO Product ID
WHOAPI-203
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Levofloxacin
Confirmation of WHO API prequalification document (version date)
Applicant organization
Zhejiang Langhua Pharmaceutical Co Ltd
No 7, Donghai 3rd Avenue, Zhejiang Provincial Chemical & Medical Materials Base Linhai Zone
Linhai City,
Zhejiang
317 016
China
APIMF Version Number
DMF-ZF00W00A-05/October-2020
DMF-ZF00W00A-05/October-2020
DMF-ZF00W00A-05/October-2020
Product Grades
API specification number
QS-ZF00W-10
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Colorless transparent polyethylene plastic bags in fibre drum
API Manufacturing Site(s)
Zhejiang Langhua Pharmaceutical Co Ltd
No 7, Donghai 3rd Avenue, Zhejiang Provincial Chemical & Medical Materials Base Linhai Zone
Linhai City,
Zhejiang
317 016
China