Product details
WHO Product ID
WHOAPI-264
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
Anhui Biochem Bio-Pharmaceutical Co Ltd
30 Hongfeng Road, Hi-Tech Development Zone
Hefei City,
Anhui
230088
China
APIMF Version Number
ABCP/ZDV/OP/05/Feb-2021
ABCP/ZDV/RP/05/Feb-2021
ABCP/ZDV/OP/05/Feb-2021/Amendment 01-Oct-2021
ABCP/ZDV/RP/05/Feb-2021/Amendment 01-Oct-2021
ABCP/ZDV/OP/05/Feb-2021/Amendment 02-July-2023
ABCP/ZDV/RP/05/Feb-2021/Amendment 02-July-2023
ABCP/ZDV/RP/05/Feb-2021/Amendment 02-Oct-2023
ABCP/ZDV/OP/05/Feb-2021/Amendment 02-Oct-2023
ABCP/ZDV/RP/05/Feb-2021
ABCP/ZDV/OP/05/Feb-2021/Amendment 01-Oct-2021
ABCP/ZDV/RP/05/Feb-2021/Amendment 01-Oct-2021
ABCP/ZDV/OP/05/Feb-2021/Amendment 02-July-2023
ABCP/ZDV/RP/05/Feb-2021/Amendment 02-July-2023
ABCP/ZDV/RP/05/Feb-2021/Amendment 02-Oct-2023
ABCP/ZDV/OP/05/Feb-2021/Amendment 02-Oct-2023
Product Grades
API specification number
QC-4053 Version 13
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Double layer polyethylene bags, the inner bag is transparent and second bag is black. The bags are sealed and placed in paper drum, and lead seal.
API Manufacturing Site(s)
Anhui Biochem Pharmaceutical Co Ltd
Zone B, Innovation Avenue, Taihe Industrial Park
Anhui
China