Product details
WHO Product ID
WHOAPI-038
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Tenofovir disoproxil fumarate
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/TCF/AP/010/04, May 2021
MLL/TCF/AP/010/04, May 2021-Amend-01, Dec 2022
MLL/TCF/RP/010/05, May 2021-Amend-01, Dec 2022
MLL/TCF/AP/010/04, May 2021-Amend-02, Feb 2023
MLL/TCF/AP/010/04, May 2021/Amend 03, Mar 2024
MLL/TCF/RP/010/05, May 2021/Amend 02, Mar 2024
MLL/TCF/AP/010/04, May 2021/Amend 04, June 2024
MLL/TCF/RP/010/05, May 2021/Amend 03, June 2024
MLL/TCF/AP/010/04, May 2021/Amend 05, July 2024
MLL/TCF/RP/010/05, May 2021/Amend 04, July 2024
MLL/TCF/AP/010/04, May 2021/Amend 06, Nov 2024
MLL/TCF/RP/010/05, May 2021/Amend 05, Nov 2024
MLL/TCF/AP/010/04, May 2021/Amend 07, March 2025
MLL/TCF/RP/010/05, May 2021/Amend 06, March 2025
MLL/TCF/AP/010/04, May 2021/Amend 08, May 2025
MLL/TCF/RP/010/05, May 2021/Amend 07, May 2025
MLL/TCF/AP/010/04, May 2021/Amend 09, Sep 2025
MLL/TCF/RP/010/05, May 2021/Amend 08, Sep 2025
MLL/TCF/AP/010/04, May 2021-Amend-01, Dec 2022
MLL/TCF/RP/010/05, May 2021-Amend-01, Dec 2022
MLL/TCF/AP/010/04, May 2021-Amend-02, Feb 2023
MLL/TCF/AP/010/04, May 2021/Amend 03, Mar 2024
MLL/TCF/RP/010/05, May 2021/Amend 02, Mar 2024
MLL/TCF/AP/010/04, May 2021/Amend 04, June 2024
MLL/TCF/RP/010/05, May 2021/Amend 03, June 2024
MLL/TCF/AP/010/04, May 2021/Amend 05, July 2024
MLL/TCF/RP/010/05, May 2021/Amend 04, July 2024
MLL/TCF/AP/010/04, May 2021/Amend 06, Nov 2024
MLL/TCF/RP/010/05, May 2021/Amend 05, Nov 2024
MLL/TCF/AP/010/04, May 2021/Amend 07, March 2025
MLL/TCF/RP/010/05, May 2021/Amend 06, March 2025
MLL/TCF/AP/010/04, May 2021/Amend 08, May 2025
MLL/TCF/RP/010/05, May 2021/Amend 07, May 2025
MLL/TCF/AP/010/04, May 2021/Amend 09, Sep 2025
MLL/TCF/RP/010/05, May 2021/Amend 08, Sep 2025
Product Grades
API specification number
CQA/STP/API/058/04
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Antistatic white low-density polyethylene (LDPE) bag under nitrogen atmosphere, placed in an another antistatic black polyethylene bag, sealed and placed in to triple polylaminated aluminium bag and sealed, then placed in an HDPE drum.
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