Product details
WHO Product ID
WHOAPI-172
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Reproductive health
Grade
Standard
INN
Levonorgestrel
Confirmation of WHO API prequalification document (version date)
Applicant organization
Qinhuangdao Zizhu Pharmaceutical Co Ltd
No 27 Chaoyang North Road, Chaoyang
Beijing,
100 024
China
APIMF Version Number
QZP/LNG/OP/06/2021-04-28
QZP/LNG/RP/06/2021-04-28
QZP/LNG/OP/06/2021-04-28/Amend 01-2022-07-05
QZP/LNG/RP/06/2021-04-28/Amend 01-2022-07-05
QZP/LNG/OP/06/2021-04-28/ Amend 02-2022-09-02
QZP/LNG/RP/06/2021-04-28
QZP/LNG/OP/06/2021-04-28/Amend 01-2022-07-05
QZP/LNG/RP/06/2021-04-28/Amend 01-2022-07-05
QZP/LNG/OP/06/2021-04-28/ Amend 02-2022-09-02
Product Grades
API specification number
QZ01-STP01-005-9
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Double LDPE bag in aluminium drum
API Manufacturing Site(s)
Qinhuangdao Zizhu Pharmaceutical Co Ltd
No. 10 Longhai Road, Economic & Technological Development Zone
Qinhuangdao City,
Hebei
066 004
China