Product details
WHO Product ID
WHOAPI-072
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Zidovudine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Tianish Laboratories Private Limited
Plot No. 564/A/22, Road No. 92, Jubilee Hills, Filmnagar, Shaikpet
Hyderabad,
Telangana
500096
India
APIMF Version Number
MLL/ZDU/AP/006/03, July 2020
MLL/ZDU/RP/006/03, July-2020
MLL/ZDU/AP/006/03, July 2020 / Amend 01-Apr 2021
MLL/ZDU/AP/006/03, July 2020/Amend 03-Jul 2022
MLL/ZDU/RP/006/03, July 2020/Amend 01-Jul 2022
MLL/ZDU/AP/006/03, July 2020/Amend 04-Jan 2023
MLL/ZDU/RP/006/03, July 2020/Amend 02-Jan 2023
MLL/ZDU/RP/006/03, July-2020
MLL/ZDU/AP/006/03, July 2020 / Amend 01-Apr 2021
MLL/ZDU/AP/006/03, July 2020/Amend 03-Jul 2022
MLL/ZDU/RP/006/03, July 2020/Amend 01-Jul 2022
MLL/ZDU/AP/006/03, July 2020/Amend 04-Jan 2023
MLL/ZDU/RP/006/03, July 2020/Amend 02-Jan 2023
Product Grades
API specification number
STP/ZDU/FPR/013/02
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
There are two alternative container systems: 1. White PE bag / black PE bag / HDPE drum or 2. PE bag / black PE bag / cardboard box
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India
Tianish Laboratories Private Limited
Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India
Tianish Laboratories Private Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India