Product details
WHO Product ID
WHOAPI-428
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Lamivudine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Styrax Life Sciences Pvt Ltd
Plot no. 5g, Atchuthapuram, Rambili Mandal, Anakapalli
Andhra Pradesh
531061
India
APIMF Version Number
SLS/LVS-II/OP/01/NOV-24
SLS/LVS-II/RP/01/NOV-24
SLS/LVS-II/RP/01/NOV-24
Product Grades
API specification number
FPSLVS-II002/10
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Primary packaging: White/transparent LDPE bag.
Secondary packaging: Black LDPE bag.
Tertiary packaging: HDPE drum.
Secondary packaging: Black LDPE bag.
Tertiary packaging: HDPE drum.
API Manufacturing Site(s)
Styrax Life Sciences Pvt Ltd
Plot no. 5g, Atchuthapuram, Rambili Mandal, Anakapalli
Andhra Pradesh
531061
India