Product details
WHO Product ID
WHOAPI-167
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Zidovudine
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
AP/DMF-AT00N00-04/October 2020
RP/DMF-AT00N00-04/October 2020
AP/DMF-AT00N00-04/May 2021/Amendment 01-May-2021
RP/DMF-AT00N00-04/October 2020
AP/DMF-AT00N00-04/May 2021/Amendment 01-May-2021
Product Grades
API specification number
QS-AT00W-07
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Primary packaging: double layer polyethylene plastic bags; secondary packaging is a fiber drum closed with metallic lid and tightened with the metallic ring.
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