Product details
WHO Product ID
WHOAPI-046
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
Shanghai Desano Chemical Pharmaceutical Co Ltd
1479 Zhangheng Road, Zhangjiang Hi-Tech Park, Pudong
Shanghai,
201 203
China
APIMF Version Number
Desano/Lamivudine/OP/0004/2020-09-04;
Desano/Lamivudine/RP/0004/2020-09-04;
0004-Amendment 01 –November 2020;
0004-Amendment 02-August 2022;
Desano/Lamivudine/RP/0004/2020-09-04/Amen03-Apr-2023
Desano/Lamivudine/OP/0004/2020-09-04/ Amen03-Apr-2023
Desano/Lamivudine/RP/0004/2020-09-04;
0004-Amendment 01 –November 2020;
0004-Amendment 02-August 2022;
Desano/Lamivudine/RP/0004/2020-09-04/Amen03-Apr-2023
Desano/Lamivudine/OP/0004/2020-09-04/ Amen03-Apr-2023
Product Grades
API specification number
SOP-B-QC-108-07
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Inner packaging material: clear double pharmaceutical grade low density polythylene bags separately tied; Outer packaging material: fibre drum
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China