Product details
WHO Product ID
WHOAPI-112
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Lamivudine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Shijiazhuang Lonzeal Pharmaceuticals Co Ltd
Workshop No.303, 104, 101 and 102, No.16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
China
APIMF Version Number
LONZEAL/LAMIVUDINE/OP/09/MAY-2019
LONZEAL/LAMIVUDINE/RP/09/ MAY-2019
Amend 01-DEC 2019 Amend 02-APR-2020
Amend 04-JAN-2021 Amend 03-SEP-2020
LONZEAL/LAMIVUDINE/RP/09/ MAY-2019
Amend 01-DEC 2019 Amend 02-APR-2020
Amend 04-JAN-2021 Amend 03-SEP-2020
Product Grades
API specification number
TS05-096-D01
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Double LDPE bags in all paper barrels
API Manufacturing Site(s)
Shijiazhuang Lonzeal Pharmaceuticals Co Ltd
Workshop No.303, 104, 101 and 102, No.16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
China