Product details
WHO Product ID
WHOAPI-287
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Tenofovir disoproxil fumarate
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/TENOFOVIR DISOPROXIL FUMARATE/OP/02/JUL-2021
LONZEAL/TENOFOVIR DISOPROXIL FUMARATE/RP/02/JUL-2021
LONZEAL/TENOFOVIR DISOPROXIL FUMARATE/OP/02/JUL-2021/AMEND 02-FEB-2022
LONZEAL/TENOFOVIR DISOPROXIL FUMARATE/RP/02/JUL-2021/AMEND 03- NOV.-2022
LONZEAL/TENOFOVIR DISOPROXIL FUMARATE/OP/02/JUL-2021/AMEND 03- NOV.-2022
LONZEAL/TENOFOVIR DISOPROXIL FUMARATE/RP/02/JUL-2021
LONZEAL/TENOFOVIR DISOPROXIL FUMARATE/OP/02/JUL-2021/AMEND 02-FEB-2022
LONZEAL/TENOFOVIR DISOPROXIL FUMARATE/RP/02/JUL-2021/AMEND 03- NOV.-2022
LONZEAL/TENOFOVIR DISOPROXIL FUMARATE/OP/02/JUL-2021/AMEND 03- NOV.-2022
Product Grades
API specification number
TS05-094-02
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Double low-density polyethylene (LDPE) placed in all-paper barrel.
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