Product details
WHO Product ID
WHOAPI-429
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
Styrax Pharma Pvt Ltd
Plot No. 27B, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531021
India
APIMF Version Number
STYRAX/TDF/OP/00/2026-01-10/Amend06-Jan-25
STYRAX/TDF/RP/01/2025-07-10/Amend04-July-25
STYRAX/TDF/RP/01/2025-07-10/Amend04-July-25
Product Grades
API specification number
FPSTDF-I001/10 Rev. No. 10
Storage condition
Store in a refrigerator (2°C to 8°C), protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Primary packing: White low-density polyethylene bag.
Secondary packing: Black low-density polyethylene bag.
Tertiary: Triple laminated aluminium bag/foil.
Quaternary: High density polyethylene drum.
Secondary packing: Black low-density polyethylene bag.
Tertiary: Triple laminated aluminium bag/foil.
Quaternary: High density polyethylene drum.
API Manufacturing Site(s)
Styrax Pharma Pvt Ltd
Plot No. 27B, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531021
India