Product details
WHO Product ID
WHOAPI-065
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Ritonavir
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/RIV/AP/008/03 – September 2020
MLL/RIV/RP/008/03 – September 2020
MLL/RIV/AP/008/03 – September 2020 / Amend 01- July 2021
MLL/RIV/RP/008/03 – September 2020 Amend 01- July 2021
MLL/RIV/AP/008/03/September 2020/ Amend 02 - April 2022
MLL/RIV/RP/008/03/September 2020/ Amend 02 - April 2022
MLL/RIV/AP/008/03 – September 2020 Amend 03- June 2023
MLL/RIV/RP/008/03 – September 2020 Amend 03- June 2023
MLL/RIV/AP/008/03/September 2020 / Amend 04 - October 2023
MLL/RIV/RP/008/03/September 2020 / Amend 04 - October 2023
MLL/RIV/AP/008/03/September 2020 / Amend 05 -December 2023
MLL/RIV/RP/008/03/September 2020 / Amend 05 - December 2023
MLL/RIV/AP/008/03/September 2020 /Amend 06, June 2024
MLL/RIV/RP/008/03/September 2020 /Amend 06, June 2024
MLL/RIV/AP/008/03/September 2020 / Amend 07 - September 2025
MLL/RIV/RP/008/03/September 2020 / Amend 07 - September 2025
MLL/RIV/RP/008/03 – September 2020
MLL/RIV/AP/008/03 – September 2020 / Amend 01- July 2021
MLL/RIV/RP/008/03 – September 2020 Amend 01- July 2021
MLL/RIV/AP/008/03/September 2020/ Amend 02 - April 2022
MLL/RIV/RP/008/03/September 2020/ Amend 02 - April 2022
MLL/RIV/AP/008/03 – September 2020 Amend 03- June 2023
MLL/RIV/RP/008/03 – September 2020 Amend 03- June 2023
MLL/RIV/AP/008/03/September 2020 / Amend 04 - October 2023
MLL/RIV/RP/008/03/September 2020 / Amend 04 - October 2023
MLL/RIV/AP/008/03/September 2020 / Amend 05 -December 2023
MLL/RIV/RP/008/03/September 2020 / Amend 05 - December 2023
MLL/RIV/AP/008/03/September 2020 /Amend 06, June 2024
MLL/RIV/RP/008/03/September 2020 /Amend 06, June 2024
MLL/RIV/AP/008/03/September 2020 / Amend 07 - September 2025
MLL/RIV/RP/008/03/September 2020 / Amend 07 - September 2025
Product Grades
API specification number
STP/FPR/RIW/001/00
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Ritonavir is packaged in (from inner layer to outer layer): Antistatic LDPE bag under nitrogen, tied with PP seal / antistatic black polyethylene bag / triple polylaminated aluminium bag sealed with a hot sealer / HDPE drum closed by a clamp.
API Manufacturing Site(s)
Matrix Pharmacorp Private Limited
Unit 8, Gaitula Chodavaram, Poosapatirega Mandal, Vizianagaram
Andhra Pradesh
535 204
India