Product details
WHO Product ID
WHOAPI-419
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Reproductive health
Type
None
Grade
micronised
INN
Medroxyprogesterone acetate - Sterile
Confirmation of WHO API prequalification document (version date)
Applicant organization
Zhejiang Xianju Pharmaceutical Co., Ltd.
No. 1 Xianyao Road
Xianju,
Zhejiang
317300
China
APIMF Version Number
Xianju Pharma/MPA/OP/02/Nov-2023
Xianju Pharma/MPA/RP/02/Nov-2023
Xianju Pharma/MPA/RP/02/Nov-2023
Product Grades
API specification number
SOP-AOP-473, version 03
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
The product is placed in three-layers of LDPE bag. The first layer is closed by cable ties and the other two layers are thermally sealed. The primary packaging is placed in aluminium tin for structural support.
API Manufacturing Site(s)
Zhejiang Xianju Pharmaceutical Co., Ltd. (Taizhou Xianju Site)
No. 3 Donghai Fourth Avenue,, Zhejiang Toumen Port Economic Development Zone, Linhai
Taizhou,
Zhejiang
317016
China