Product details
WHO Product ID
WHOAPI-245
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Levofloxacin
Confirmation of WHO API prequalification document (version date)
Applicant organization
Shaoxing Jingxin Pharmaceutical Co Ltd
Shangyu,
Zhejiang
312369
China
APIMF Version Number
Levofloxacin/AP/06/2022-04-28
Levofloxacin/RP/05/2022-04-28
Amend 04-2023-11-16
Amend 05-2024-02-05
Levofloxacin/RP/05/2022-04-28
Amend 04-2023-11-16
Amend 05-2024-02-05
Product Grades
API specification number
D-QA533-R07
Storage condition
Do not store above 30°C
Storage period (months)
48
Duration type
Retest period
Packaging
In a colorless LDPE bag in a black LDPE bag placed in a cardboard drum
API Manufacturing Site(s)
Shaoxing Jingxin Pharmaceutical Co Ltd
Shangyu,
Zhejiang
312369
China