Product details
WHO Product ID
WHOAPI-301
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Neglected tropical diseases
Grade
Standard
INN
Praziquantel
Confirmation of WHO API prequalification document (version date)
Applicant organization
Hisun Pharmaceutical (Nantong) Co Ltd
No.18, 4th Haibin Road, Rudong Coastal Economic Development Zone
Nantong City,
Jiangsu
226407
China
APIMF Version Number
HISUN/PZQT/WHO/AP/003/Dec-2020
HISUN/PZQT/WHO/RP/003/Dec-2020
Amendment 01-December 2022
HISUN/PZQT/WHO/RP/003/Dec-2020
Amendment 01-December 2022
Product Grades
API specification number
H8-QS-10001(12)
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Double polyethylene bag sealed. Shipped in an aluminum container, carton, flange bucket or fiber drum.
API Manufacturing Site(s)
Hisun Pharmaceutical (Nantong) Co Ltd
No.18, 4th Haibin Road, Rudong Coastal Economic Development Zone
Nantong City,
Jiangsu
226407
China