Product details
WHO Product ID
WHOAPI-387
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
Laurus Labs Limited
2nd Floor, Serene Chambers, Road No. 7, Banjara Hills
Hyderabad,
Telangana
500 034
India
APIMF Version Number
LL/Dolutegravir Sodium/OP/01/June-2020
LL/Dolutegravir Sodium/RP/01/June-2020
LL/Dolutegravir Sodium/OP/01/June-2020/ Amend-01 April-2023
LL/Dolutegravir Sodium/RP/01/June-2020/ Amend-01 April-2023
LL/Dolutegravir Sodium/OP/01/June-2020 Amend-02 October-2023
LL/Dolutegravir Sodium/RP/01/June-2020 Amend-02 October-2023
LL/Dolutegravir Sodium/RP/01/June-2020/Amend-03 February-2024
LL/Dolutegravir Sodium/RP/01/June-2020
LL/Dolutegravir Sodium/OP/01/June-2020/ Amend-01 April-2023
LL/Dolutegravir Sodium/RP/01/June-2020/ Amend-01 April-2023
LL/Dolutegravir Sodium/OP/01/June-2020 Amend-02 October-2023
LL/Dolutegravir Sodium/RP/01/June-2020 Amend-02 October-2023
LL/Dolutegravir Sodium/RP/01/June-2020/Amend-03 February-2024
Product Grades
API specification number
FS/DDTGS/02 (version 2.0)
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
60
Duration type
Shelf life
Packaging
double transparent low-density polyethylene (LDPE) bags
API Manufacturing Site(s)
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India