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
Matrix Pharmacorp Private Limited
Plot No. 14, 99 and 100, IDA Pashamylaram Phase-II
Patancheru, Sangareddy District,
Telangana
502307
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/Amend 05-June 2024
MLL/EFD/AP/004/04, August 2021/Amend 04-June 2024
MLL/EFD/RP/004/04, August 2021/Amend 06-Sept 2025
MLL/EFD/AP/004/05, Aug 2021/Amend 05-Sept 2025
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/Amend 05-June 2024
MLL/EFD/AP/004/04, August 2021/Amend 04-June 2024
MLL/EFD/RP/004/04, August 2021/Amend 06-Sept 2025
MLL/EFD/AP/004/05, Aug 2021/Amend 05-Sept 2025
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)
Matrix Pharmacorp Private Limited
Unit 8, Gaitula Chodavaram, Poosapatirega Mandal, Vizianagaram
Andhra Pradesh
535 204
India
Matrix Pharmacorp Private Limited
Unit 10, Plot No. 86, SEZ, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District
Visakhapatnam,
Andhra Pradesh
531019
India