Product details
WHO Product ID
WHOAPI-193
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Abacavir (sulfate)
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/ABACAVIR SULFATE/OP/04/SEPTEMBER-2020
LL/ABACAVIR SULFATE/RP/04/SEPTEMBER-2020
LL/ABACAVIR SULFATE/OP/04/SEPTEMBER-2020/Amend 01-February-2021
LL/ABACAVIR SULFATE/RP/04/SEPTEMBER-2020/Amend 01-February-2021
LL/ABACAVIR SULFATE/OP/04/SEPTEMBER-2020/Amend 02-December-2022
LL/ABACAVIR SULFATE/RP/04/SEPTEMBER-2020/Amend 02-December-2022
LL/ABACAVIR SULFATE/OP/04/September-2020/Amend-03-March-2023
LL/ABACAVIR SULFATE/RP/04/September-2020/Amend-03-March-2023
LL/ABACAVIR SULFATE/RP/04/SEPTEMBER-2020
LL/ABACAVIR SULFATE/OP/04/SEPTEMBER-2020/Amend 01-February-2021
LL/ABACAVIR SULFATE/RP/04/SEPTEMBER-2020/Amend 01-February-2021
LL/ABACAVIR SULFATE/OP/04/SEPTEMBER-2020/Amend 02-December-2022
LL/ABACAVIR SULFATE/RP/04/SEPTEMBER-2020/Amend 02-December-2022
LL/ABACAVIR SULFATE/OP/04/September-2020/Amend-03-March-2023
LL/ABACAVIR SULFATE/RP/04/September-2020/Amend-03-March-2023
Product Grades
API specification number
FS/CABS/02 version 5.0
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
60
Duration type
Shelf life
Packaging
Double transparent LDPE bag placed in a HDPE container
API Manufacturing Site(s)
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India