Product details
WHO Product ID
WHOAPI-038
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
Tianish Laboratories Private Limited
Plot No. 564/A/22, Road No. 92, Jubilee Hills, Filmnagar, Shaikpet
Hyderabad,
Telangana
500096
India
APIMF Version Number
MLL/TCF/AP/010/04, May 2021;
MLL/TCF/RP/010/05, May 2021
MLL/TCF/RP/010/05, May 2021
Product Grades
API specification number
CQA/STP/API/014/04
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Antistatic white low-density polyethylene (LDPE) bag under nitrogen atmosphere, placed in an another antistatic black polyethylene bag, sealed and placed in to triple polylaminated aluminium bag and sealed, then placed in an HDPE drum.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Plot No. 86, Ramky Pharma City (India) Ltd, Parawada Mandal, Anakapalli District
Jawaharlal Nehru Pharma City,
Andhra Pradesh
531019
India
Tianish Laboratories Private Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India