Product details
WHO Product ID
WHOAPI-362
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Dolutegravir (sodium)
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/DGS/AP/001/03, April 2022
MLL/DGS/RP/001/03, April 2022
MLL/DGS/AP/001/03, April 2022/Amend-01, September 2022
MLL/DGS/RP/001/03, April 2022/Amend-01, September 2022
MLL/DGS/AP/001/03, April 2022/Amend-01, September 2022; Amend-02, February 2024
MLL/DGS/RP/001/03, April 2022/Amend-01, September 2022; Amend-02, February 2024
MLL/DGS/AP/001/03, April 2022/Amend-01, September 2022; Amend-02, February 2024; Amend-03, April 2024
MLL/DGS/RP/001/03, April 2022
MLL/DGS/AP/001/03, April 2022/Amend-01, September 2022
MLL/DGS/RP/001/03, April 2022/Amend-01, September 2022
MLL/DGS/AP/001/03, April 2022/Amend-01, September 2022; Amend-02, February 2024
MLL/DGS/RP/001/03, April 2022/Amend-01, September 2022; Amend-02, February 2024
MLL/DGS/AP/001/03, April 2022/Amend-01, September 2022; Amend-02, February 2024; Amend-03, April 2024
Product Grades
API specification number
STP/DGS/FPR/004/04
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
White polyethylene bag (LDPE), placed in a HMLDPE bag. Both bags are placed in triple laminated aluminium bag and packed in HDPE drums.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India