Product details
WHO Product ID
WHOAPI-210
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Reproductive health
Grade
Sterile-Micronized
INN
Medroxyprogesterone acetate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Farmabios S.p.A
Via Pavia 1, Gropello Cairoli
Pavia
27027
Italy
APIMF Version Number
Applicant Part: 062010 Rev. 04 (Sept 2014)
Restricted Part: 062010 Rev. 04 (Sept 2014)
Restricted Part: 062010 Rev. 04 (Sept 2014)
Product Grades
API specification number
SOP-QC-1083 Rel 09
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
High density polyethylene HDPE drum lined with black low density polyethylene (LDPE) bag followed by transparent low density polyethylene (LDPE) bag.
API Manufacturing Site(s)
Farmabios S.p.A
Via Pavia 1, Gropello Cairoli
27027
Italy