Product details
WHO Product ID
WHOAPI-195a
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
Laurus Labs Limited
2nd Floor, Serene Chambers, Road No. 7, Banjara Hills
Hyderabad,
Telangana
500 034
India
APIMF Version Number
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/OP/03/JANUARY-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/RP/03/JANUARY-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/OP/03/JANUARY-2020/Amend 01-July-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/RP/03/JANUARY-2020/Amend 01-July-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/RP/03/JANUARY-2020/Amend 02-September 2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/OP/03/JANUARY-2020/Amend 03-October-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/RP/03/JANUARY-2020/ Amend 03-October-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 04-June-2021
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/ Amend 03-June-2021
LL/TENOFOVIR DISOPROXIL FUMARATE(P-2)/OP/03/January 2020/Amend 05-November-2021
LL/TENOFOVIR DISOPROXIL FUMARATE(P-2)/RP/03/January 2020/Amend 05-November-2021
LL/TENOFOVIR DISOPROXIL FUMARATE(P-2)/OP/03/January 2020/Amend 06-February 2022
LL/TENOFOVIR DISOPROXIL FUMARATE(P-2)/RP/03/January 2020/Amend 06-February 2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 07-June-2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/ Amend 07-June-2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 08-November-2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/Amend 08-November-2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 09-June-2023
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/Amend 09-June-2023
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 10-March-2024
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/ Amend 10-March-2024
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/RP/03/JANUARY-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/OP/03/JANUARY-2020/Amend 01-July-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/RP/03/JANUARY-2020/Amend 01-July-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/RP/03/JANUARY-2020/Amend 02-September 2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/OP/03/JANUARY-2020/Amend 03-October-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2)/RP/03/JANUARY-2020/ Amend 03-October-2020
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 04-June-2021
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/ Amend 03-June-2021
LL/TENOFOVIR DISOPROXIL FUMARATE(P-2)/OP/03/January 2020/Amend 05-November-2021
LL/TENOFOVIR DISOPROXIL FUMARATE(P-2)/RP/03/January 2020/Amend 05-November-2021
LL/TENOFOVIR DISOPROXIL FUMARATE(P-2)/OP/03/January 2020/Amend 06-February 2022
LL/TENOFOVIR DISOPROXIL FUMARATE(P-2)/RP/03/January 2020/Amend 06-February 2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 07-June-2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/ Amend 07-June-2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 08-November-2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/Amend 08-November-2022
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 09-June-2023
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/Amend 09-June-2023
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /OP/03/JANUARY-2020/Amend 10-March-2024
LL/TENOFOVIR DISOPROXIL FUMARATE (P-2) /RP/03/JANUARY-2020/ Amend 10-March-2024
Product Grades
API specification number
FS/DTDF/02 version No. 1
Storage condition
Store in a refrigerator (2 °C to 8 °C)
Storage period (months)
60
Duration type
Retest period
Packaging
Transparent double low density polyethylene bag tied with nylon strip seal, housed within a triple laminated sunlight barrier (TLSB) bag and is heat sealed and finally kept in High Density polyethylene drums.
API Manufacturing Site(s)
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
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