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/RP/006/03, April 2021
Product Grades
API specification number
STP/FPR/SVL/002/00
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
There are two alternative container systems: 1. PE bag/black PE bag/HDPE drum or 2.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