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
Tianish Laboratories Private Limited
Plot No. 564/A/22, Road No. 92, Jubilee Hills, Filmnagar, Shaikpet
Hyderabad,
Telangana
500096
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)
Tianish Laboratories Private Limited
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India
Tianish Laboratories Private Limited
Unit 2, Survey 10/42, Gaddapotharam, Sangareddy District
Kazipally Industrial Area,
Telangana
502 319
India