Product details
WHO Product ID
WHOAPI-039
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Emtricitabine
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/EMB/AP/001/02, December 2020
MLL/EMB/RP/001/02, December 2020
MLL/EMB/AP/001/02/December 2020/Amend 01 – February 2024
MLL/EMB/RP/001/02/ December 2020/Amend 01 – February 2024
MLL/EMB/AP/001/02, December 2020/ Amend 03- August 2024
MLL/EMB/RP/001/02, December 2020/ Amend 03- August 2024
MLL/EMB/AP/001/02, December 2020/ Amend 04- February 2025
MLL/EMB/RP/001/02, December 2020/ Amend 04- February 2025
MLL/EMB/RP/001/02, December 2020/ Amend 05- June 2025
MLL/EMB/AP/001/02, December 2020/ Amend 05- August 2025
MLL/EMB/AP/001/02, December 2020/ Amend 07- September 2025
MLL/EMB/AP/001/02/December 2020/Amend 02 – June 2024
MLL/EMB/RP/001/02/ December 2020/Amend 02 – June 2024
MLL/EMB/AP/001/02, December 2020/ Amend 03- August 2024
MLL/EMB/RP/001/02, December 2020/ Amend 03- August 2024
MLL/EMB/AP/001/02, December 2020/ Amend 04- February 2025
MLL/EMB/RP/001/02, December 2020/ Amend 04- February 2025
MLL/EMB/RP/001/02, December 2020/ Amend 05- June 2025
MLL/EMB/AP/001/02, December 2020/ Amend 05- August 2025
MLL/EMB/AP/001/02, December 2020/ Amend 06- September 2025
MLL/EMB/RP/001/02, December 2020/ Amend 06- September 2025
MLL/EMB/AP/001/02, December 2020/ Amend 07- September 2025
MLL/EMB/RP/001/02, December 2020
MLL/EMB/AP/001/02/December 2020/Amend 01 – February 2024
MLL/EMB/RP/001/02/ December 2020/Amend 01 – February 2024
MLL/EMB/AP/001/02, December 2020/ Amend 03- August 2024
MLL/EMB/RP/001/02, December 2020/ Amend 03- August 2024
MLL/EMB/AP/001/02, December 2020/ Amend 04- February 2025
MLL/EMB/RP/001/02, December 2020/ Amend 04- February 2025
MLL/EMB/RP/001/02, December 2020/ Amend 05- June 2025
MLL/EMB/AP/001/02, December 2020/ Amend 05- August 2025
MLL/EMB/AP/001/02, December 2020/ Amend 07- September 2025
MLL/EMB/AP/001/02/December 2020/Amend 02 – June 2024
MLL/EMB/RP/001/02/ December 2020/Amend 02 – June 2024
MLL/EMB/AP/001/02, December 2020/ Amend 03- August 2024
MLL/EMB/RP/001/02, December 2020/ Amend 03- August 2024
MLL/EMB/AP/001/02, December 2020/ Amend 04- February 2025
MLL/EMB/RP/001/02, December 2020/ Amend 04- February 2025
MLL/EMB/RP/001/02, December 2020/ Amend 05- June 2025
MLL/EMB/AP/001/02, December 2020/ Amend 05- August 2025
MLL/EMB/AP/001/02, December 2020/ Amend 06- September 2025
MLL/EMB/RP/001/02, December 2020/ Amend 06- September 2025
MLL/EMB/AP/001/02, December 2020/ Amend 07- September 2025
Product Grades
API specification number
STP/FPR/EMF/006/02
Storage condition
Do not store above 30°C
Storage period (months)
36
Duration type
Retest period
Packaging
PE bag (translucent) in black PE bag with HDPE container (sealed)
API Manufacturing Site(s)
Matrix Pharmacorp Private Limited
Unit 1, Survey 10, Kazipally Industrial Area Gaddapotharam, Sangareddy District
Hyderabad,
Telangana
502 319
India