Product details
WHO Product ID
WHOAPI-069
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Lamivudine
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/SVL/AP/006/03, April 2021
MLL/SVL/RP/006/03, April 2021
MLL/SVL/AP/006/03, April 2021;Amend 01, June 2024
MLL/SVL/RP/006/03, April 2021; Amend 01, June 2024
MLL/SVL/AP/006/03, April 2021; Amend-02, July 2024
MLL/SVL/RP/006/03, April 2021; Amend-02, July 2024
MLL/SVL/AP/006/03, April 2021; Amend-03, September 2024
MLL/SVL/RP/006/03, April 2021; Amend-03, September 2024
MLL/SVL/RP/006/03, April 2021/Amend-04, February 2025
MLL/SVL/RP/006/03, April 2021
MLL/SVL/AP/006/03, April 2021;Amend 01, June 2024
MLL/SVL/RP/006/03, April 2021; Amend 01, June 2024
MLL/SVL/AP/006/03, April 2021; Amend-02, July 2024
MLL/SVL/RP/006/03, April 2021; Amend-02, July 2024
MLL/SVL/AP/006/03, April 2021; Amend-03, September 2024
MLL/SVL/RP/006/03, April 2021; Amend-03, September 2024
MLL/SVL/RP/006/03, April 2021/Amend-04, February 2025
Product Grades
API specification number
STP/FPR/SVL/002/01 (Unit-1) & STP/FPR/SVN/013/00 (Unit-2)
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
There are two alternative container systems: 1. White PE bag/black PE bag/HDPE drum, or 2. White PE bag/black PE bag/cardboard box
API Manufacturing Site(s)
Matrix Pharmacorp Private Limited
Unit 1, Survey 10, Kazipally Industrial Area Gaddapotharam, Sangareddy District
Hyderabad,
Telangana
502 319
India
Matrix Pharmacorp Private Limited
Unit 2, Survey 10 and 42, Kazipally Industrial Area, Gaddapotharam, Sangareddy District
Hyderabad,
Telangana
502 319
India