WHOAPI-058: Tenofovir disoproxil fumarate | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)

Product details

WHO Product ID

WHOAPI-058

Status

Prequalified

Date of prequalification

23 Aug, 2018

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)

27 May, 2024

Applicant organization

Sun Pharmaceutical Industries Limited

Sun House, 201 B/1, Western Express Highway, Goregaon (East)

Mumbai,

400063

India

APIMF Version Number

Tenofovir Disoproxil Fumarate/OP/05/Oct-2020
Tenofovir Disoproxil Fumarate/RP/05/Oct-2020
Tenofovir Disoproxil Fumarate/RP/005/Oct-2020/Amend 07-Apr-2021
Tenofovir Disoproxil Fumarate/OP/005/Oct-2020/Amend 25-Nov-2021
Tenofovir Disoproxil Fumarate/RP/005/Oct-2020/Amend 25-Nov-2021
Tenofovir Disoproxil Fumarate/OP/005/Oct-2020/Amend 23-May-2023
Tenofovir Disoproxil Fumarate/RP/005/Oct-2020/Amend 23-May-2023
Tenofovir Disoproxil Fumarate/RP/005/Oct-2020/Amend 10-August-2023
Tenofovir Disoproxil Fumarate/OP/005/Oct-2020/Amend 18-Mar-2024
Tenofovir Disoproxil Fumarate/RP/005/Oct-2020/Amend 18-Mar-2024

Product Grades

API specification number

AS007151 version 5.0

Storage condition

Store in a refrigerator (2 °C to 8 °C), protect from moisture, protect from ligh

Storage period (months)

Duration type

Retest period

Packaging

Primary packaging: LDPE bag; Middle bag: HMHDPE/LDPE/LLDPE; Outer bag: polyester film/Alu/LDPE placed in a HDPE drum

API Manufacturing Site(s)

Sun Pharmaceutical Industries Limited

Village Toansa, P.O. Rail Majra, Dist. S.B.S. Nagar (Nawanshahar)

Punjab

144 533

India