Product details
WHO Product ID
WHOAPI-010
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Abacavir (sulfate)
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/ABC/AP/008/03, February 2021
MLL/ABC/RP/008/03, February 2021
MLL/ABC/AP/008/03, February 2021/Amend 01- January 2024
MLL/ABC/RP/008/03, February 2021/Amend 01- January 2024
MLL/ABC/AP/008/03, February 2021/Amend-02, June 2024
MLL/ABC/RP/008/03, February 2021/Amend 02- June 2024
MLL/ABC/AP/008/03, February 2021/Amend-03, September – 2025
MLL/ABC/RP/008/03, February 2021/Amend-03, September - 2025
MLL/ABC/RP/008/03, February 2021
MLL/ABC/AP/008/03, February 2021/Amend 01- January 2024
MLL/ABC/RP/008/03, February 2021/Amend 01- January 2024
MLL/ABC/AP/008/03, February 2021/Amend-02, June 2024
MLL/ABC/RP/008/03, February 2021/Amend 02- June 2024
MLL/ABC/AP/008/03, February 2021/Amend-03, September – 2025
MLL/ABC/RP/008/03, February 2021/Amend-03, September - 2025
Product Grades
API specification number
STP/FPR/ABC/001/02 (Unit-8) & STP/ABC/FPR/008/00 (Unit-10)
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
White LDPE bag closed and placed in a second PE bag which is black closed and placed in HDPE drums
API Manufacturing Site(s)
Matrix Pharmacorp Private Limited
Unit 10, Plot No. 86, SEZ, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District
Visakhapatnam,
Andhra Pradesh
531019
India
Matrix Pharmacorp Private Limited
Unit 8, Gaitula Chodavaram, Poosapatirega Mandal, Vizianagaram
Andhra Pradesh
535 204
India