Product details
WHO Product ID
WHOAPI-393
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Lopinavir
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/LOPINAVIR/OP/01/JULY-2020
LL/LOPINAVIR/RP/01/JULY-2020
LL/LOPINAVIR/OP/01/JULY-2020/Amend 03- July-2022
LL/LOPINAVIR/RP/01/JULY-2020/Amend 03- July-2022
LL/LOPINAVIR/OP/01/JULY-2020/Amend 04 - January-2023
LL/LOPINAVIR/RP/01/JULY-2020/Amend 04 - January-2023
LL/LOPINAVIR/OP/01/JULY-2020/Amend 05 – July-2023
LL/LOPINAVIR/OP/01/JULY-2020/Amend 06 – August-2023
LL/LOPINAVIR/OP/01/JULY-2020/Amend 07 – October-2023
LL/LOPINAVIR/RP/01/JULY-2020/Amend 07 - October-2023
LL/LOPINAVIR/RP/01/JULY-2020
LL/LOPINAVIR/OP/01/JULY-2020/Amend 03- July-2022
LL/LOPINAVIR/RP/01/JULY-2020/Amend 03- July-2022
LL/LOPINAVIR/OP/01/JULY-2020/Amend 04 - January-2023
LL/LOPINAVIR/RP/01/JULY-2020/Amend 04 - January-2023
LL/LOPINAVIR/OP/01/JULY-2020/Amend 05 – July-2023
LL/LOPINAVIR/OP/01/JULY-2020/Amend 06 – August-2023
LL/LOPINAVIR/OP/01/JULY-2020/Amend 07 – October-2023
LL/LOPINAVIR/RP/01/JULY-2020/Amend 07 - October-2023
Product Grades
API specification number
FS/ALVR/03 Version 0.0
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
24
Duration type
Retest period
Packaging
Double low-density polyethylene (LDPE) bag (a silica packet and a molecular sieve sachet is placed between the first and second LDPE bag). The API is then packed in a triple laminated aluminum bag and lastly placed in high density polyethylene (HDPE) container.
API Manufacturing Site(s)
Laurus Labs Limited
Unit-4, Plot No.25, 25A to 25K, APSEZ De-Notified Area, Lalamkoduru Village, Rambilli Mandal
Anakapalli,
Andhra Pradesh
531011
India