Product details
WHO Product ID
WHOAPI-389
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Atazanavir (sulfate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Sun Pharmaceutical Industries Limited
Sun House, 201 B/1, Western Express Highway, Goregaon (East)
Mumbai,
400063
India
APIMF Version Number
Atazanavir Sulfate/OP/01/October 08, 2021
Atazanavir Sulfate/OP/01/October 08, 2021
Atazanavir Sulfate/OP/01/October 08, 2021
Product Grades
API specification number
BD1279O0DB Revision 8.0
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Inner bag: Low density polyethylene transparent antistatic bag; Middle bag: Low density polyethylene black antistatic bag; Outer bag: Aluminium polyethylene laminated bag
API Manufacturing Site(s)
Sun Pharmaceutical Industries Limited
Plot No. 24/2, 25, GIDC, Phase IV, Panoli, Bharuch
Gujarat
394 116
India