Product details
WHO Product ID
WHOAPI-071
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Efavirenz
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/EFD/AP/004/05, August 2021
MLL/EFD/RP/004/04, August 2021
MLL/EFD/AP/004/05, August 2021/Amend 01-Apr 2022
MLL/EFD/RP/004/04, August 2021/Amend 01-Apr 2022
MLL/EFD/AP/004/05, August 2021/Amend 02-Jun 2022
MLL/EFD/RP/004/04, August 2021/Amend 02-Jun 2022
MLL/EFD/AP/004/05, August 2021/Amend 03-December 2023
MLL/EFD/RP/004/04, August 2021/Amend 03-December 2023
MLL/EFD/RP/004/04, August 2021/Amend 04-March 2024
MLL/EFD/RP/004/04, August 2021
MLL/EFD/AP/004/05, August 2021/Amend 01-Apr 2022
MLL/EFD/RP/004/04, August 2021/Amend 01-Apr 2022
MLL/EFD/AP/004/05, August 2021/Amend 02-Jun 2022
MLL/EFD/RP/004/04, August 2021/Amend 02-Jun 2022
MLL/EFD/AP/004/05, August 2021/Amend 03-December 2023
MLL/EFD/RP/004/04, August 2021/Amend 03-December 2023
MLL/EFD/RP/004/04, August 2021/Amend 04-March 2024
Product Grades
API specification number
CQA/STP/API/029/07
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Efavirenz is first packed in white low-density polyethylene (LDPE) bag, twist-tied, which is placed in a black polyethylene bag, twist-tied and put into HDPE drum, closed and sealed.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Plot No. 86, Ramky Pharma City (India) Ltd, Parawada Mandal, Anakapalli District
Jawaharlal Nehru Pharma City,
Andhra Pradesh
531019
India
Tianish Laboratories Private Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India