Product details
WHO Product ID
WHOAPI-346b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Micronised
INN
Lamivudine
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/Lamivudine/OP/01/DECEMBER-2021
LL/Lamivudine/RP/01/DECEMBER-2021
LL/LAMIVUDINE/OP/01/DECEMBER-2021/ Amend 01-June-2022
LL/LAMIVUDINE/RP/01/DECEMBER-2021/ Amend 01-June-2022
LL/LAMIVUDINE/OP/01/DECEMBER-2021/ Amend 02-September-2022
LL/LAMIVUDINE/RP/01/DECEMBER-2021/ Amend 02-September-2022
LL/Lamivudine/OP/01/DECEMBER-2021/Amend 04-September-2023
LL/LAMIVUDINE/RP/01/DECEMBER-2021/Amend 04- September-2023
LL/Lamivudine/RP/01/DECEMBER-2021
LL/LAMIVUDINE/OP/01/DECEMBER-2021/ Amend 01-June-2022
LL/LAMIVUDINE/RP/01/DECEMBER-2021/ Amend 01-June-2022
LL/LAMIVUDINE/OP/01/DECEMBER-2021/ Amend 02-September-2022
LL/LAMIVUDINE/RP/01/DECEMBER-2021/ Amend 02-September-2022
LL/Lamivudine/OP/01/DECEMBER-2021/Amend 04-September-2023
LL/LAMIVUDINE/RP/01/DECEMBER-2021/Amend 04- September-2023
Product Grades
API specification number
FS/ ALMD/ 02 version 9 (micronised)
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Shelf life
Packaging
Transparent low density polyethylene bag with strip seal, followed by secondary black low density polyethylene bag with strip seal and finally kept in high density polyethylene container.
API Manufacturing Site(s)
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Laurus Labs Limited
Unit-4, Plot No.25, 25A to 25K, APSEZ De-Notified Area, Lalamkoduru Village, Rambilli Mandal
Anakapalli,
Andhra Pradesh
531011
India