Product details
WHO Product ID
WHOAPI-065
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Ritonavir
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/RIV/AP/008/04, September 2022
MLL/RIV/RP/008/04, September 2022
MLL/RIV/RP/008/04, September 2022
Product Grades
API specification number
STP/FPR/RIW/001/00
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Ritonavir is packaged in (from inner layer to outer layer): Antistatic LDPE bag under nitrogen, tied with PP seal / antistatic black polyethylene bag / triple polylaminated aluminium bag sealed with a hot sealer / HDPE drum closed by a clamp.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India