Product details
WHO Product ID
WHOAPI-267
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Zidovudine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Shanghai Shyndec Pharmaceutical (Haimen) Co Ltd
No 1 Linjiang Avenue, Linjiang Town
Haimen,
Jiangsu
226133
China
APIMF Version Number
Shyndec Haimen/ZI /OP/V2.1/date in 2018-07-31
Shyndec Haimen/ZI/RP/V2.1/date in 2018-07-31
Amendment dated May 2021
Shyndec Haimen/ZI/RP/V2.1/date in 2018-07-31
Amendment dated May 2021
Product Grades
API specification number
HM-STP-QA-001-04-08 version No. 04
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Double polyethylene bag inside a cardboard drum
API Manufacturing Site(s)
Shanghai Shyndec Pharmaceutical (Haimen) Co Ltd
No 1 Linjiang Avenue, Linjiang Town
Haimen,
Jiangsu
226133
China