Product details
WHO Product ID
WHOAPI-303
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Atazanavir (sulfate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Macleods Pharmaceuticals Ltd
G-2 Mahakali Caves Road, Shanti Nagar, Andheri (E)
Mumbai,
Maharashtra
400 093
India
APIMF Version Number
PQC-APIMF-2022-0137 Macleods/Atazanavir Sulfate/APIMF/AP/28-09-2022/003-Amendment-01
Macleods/Atazanavir Sulfate/APIMF/RP/28-09-2022/003
Macleods/Atazanavir Sulfate/APIMF/RP/28-09-2022/003
Product Grades
API specification number
CO/SPC/ARD/RM003339A-004
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
60
Duration type
Shelf life
Packaging
Transparent LDPE bag inside black LDPE bag, placed in single triple laminated bag, in HDPE container.
API Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India