Product details
WHO Product ID
WHOAPI-271
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Reproductive health
Grade
Standard
INN
Medroxyprogesterone acetate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Jiangsu Grand Xianle Pharmaceutical Co Ltd
No 1 Zhongshan Seven Road, Coastal Industrial Park, Economic Development Zone, Binhai County
Yancheng,
Jiangsu
224555
China
APIMF Version Number
GXP/MPA/OP/03/May-2019
GXP/MPA/RP/03/May-2019
GXP/MPA/RP/03/May-2019
Product Grades
API specification number
QA/ST040/3
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Double-layered low density polyethylene (LDPE) bags, placed in an aluminium tin
API Manufacturing Site(s)
Jiangsu Grand Xianle Pharmaceutical Co Ltd
No 1 Zhongshan Seven Road, Coastal Industrial Park, Economic Development Zone, Binhai County
Yancheng,
Jiangsu
224555
China