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WHOAPI-413: Levofloxacin

Product details
WHO Product ID
WHOAPI-413
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
Zhejiang East-Asia Pharmaceutical Co Ltd
Coastal Industrial City
Pubagang town, Sanmen county,
Zhejiang
317 100
China
APIMF Version Number
Levofloxacin/OP/01/April-2022
Levofloxacin/RP/01/April-2022
Product Grades
API specification number
SOP-QC-8121 (02)
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Double low-density polyethylene bags individually sealed with plastic clips placed in round fiber drums.
API Manufacturing Site(s)
Zhejiang East-Asia Pharmaceutical Co Ltd
Coastal Industrial City
Pubagang town, Sanmen county,
Zhejiang
317 100
China

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