Product details
WHO Product ID
WHOAPI-338a
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
Jiangsu Chengxin Pharmaceutical Co Ltd
No.338, Shanghai Road, Binjiang Pharm-Chem Industry Park
Qidong,
Jiangsu
226221
China
APIMF Version Number
Praziquantel-APIMF-M3-OP, Version 02, 18 Dec. 2020
Praziquantel-APIMF-M3-RP, Version 02, 18 Dec. 2020
Praziquantel-APIMF-M3-OP, Version 02, 18 Dec. 2020, Amend 01, Jan 2021
Praziquantel-APIMF-M3-RP, Version 02, 18 Dec. 2020, Amend 01, Jan 2021
Praziquantel-APIMF-M3-OP, Version 02, 18 Dec 2020, Amend 02, Mar 2022
Praziquantel-APIMF-M3-RP, Version 02, 18 Dec 2020, Amend 02, Mar 2022
Praziquantel-APIMF-M3-OP, Version 02, 18 Dec 2020, Amend 03, Mar 2023
Praziquantel-APIMF-M3-RP, Version 02, 18 Dec 2020, Amend 03, Mar 2023
Praziquantel-APIMF-M3-RP, Version 02, 18 Dec. 2020
Praziquantel-APIMF-M3-OP, Version 02, 18 Dec. 2020, Amend 01, Jan 2021
Praziquantel-APIMF-M3-RP, Version 02, 18 Dec. 2020, Amend 01, Jan 2021
Praziquantel-APIMF-M3-OP, Version 02, 18 Dec 2020, Amend 02, Mar 2022
Praziquantel-APIMF-M3-RP, Version 02, 18 Dec 2020, Amend 02, Mar 2022
Praziquantel-APIMF-M3-OP, Version 02, 18 Dec 2020, Amend 03, Mar 2023
Praziquantel-APIMF-M3-RP, Version 02, 18 Dec 2020, Amend 03, Mar 2023
Product Grades
API specification number
QS-QC-0103, version 10 (non-micronized)
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 polyethylene (LDPE) bag, placed into a fiber drum.
API Manufacturing Site(s)
Jiangsu Chengxin Pharmaceutical Co Ltd
No.338, Shanghai Road, Binjiang Pharm-Chem Industry Park
Qidong,
Jiangsu
226221
China