Product details
WHO Product ID
WHOAPI-484
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Reproductive health
Type
None
Grade
Standard
INN
Levonorgestrel
Confirmation of WHO API prequalification document (version date)
Applicant organization
Jiangsu Lianhuan Pharmaceutical Co., Ltd.
No. 9 Jiankangyi Road, Biological Health Industry Park Hanjiang
Yangzhou,
Jiangsu
225127
China
APIMF Version Number
DMF-ZX(WHO)-OP-04
DMF-ZX(WHO)-RP-04
DMF-ZX(WHO)-RP-04
Product Grades
API specification number
SMPLQA-CY045-02
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Double polyethylene bags sealed with an individual tie placed in an aluminium drum and further in a slotted double corrugated carton.
API Manufacturing Site(s)
Jiangsu Lianhuan Pharmaceutical Co., Ltd.
No. 9 Jiankangyi Road, Biological Health Industry Park Hanjiang
Yangzhou,
Jiangsu
225127
China