Product details
WHO Product ID
WHOAPI-214
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Darunavir (ethanolate)
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/DRE/AP/001/04, April 2022
MLL/DRE/RP/001/04, April 2022
MLL/DRE/RP/001/04, April 2022
Product Grades
API specification number
STP/FPR/DRF/002/03
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
36
Duration type
Retest period
Packaging
Translucent polyethylene bag (LDPE), securely folded and twist-tied with a plastic rope, which is placed in another translucent polyethylene bag (HMLDPE)nitrogen flushed and surrounds silica gel, molecular sieves and heat sealed. The Translucent polyethylene bag (HMLDPE) is placed in a triple laminated aluminum bag, nitrogen flushed and surrounds silica gel, molecular sieves and heat sealed. The triple laminated bag is put into HDPE drum
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India