Product details
WHO Product ID
WHOAPI-363
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Lopinavir
Confirmation of WHO API prequalification document (version date)
Applicant organization
Shanghai Desano Chemical Pharmaceutical Co Ltd
1479 Zhangheng Road, Zhangjiang Hi-Tech Park, Pudong
Shanghai,
201 203
China
APIMF Version Number
Desano-B/Lopinavir/OP/0002/Aug-2021
Desano-B/Lopinavir/RP/0002/Aug-2021
Desano-B/Lopinavir/RP/0002/Aug-2021
Product Grades
API specification number
SOP-B-QC-1117-07
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
24
Duration type
Retest period
Packaging
Lopinavir is packed in double low-density polyethylene (LDPE) bag of pharmaceutical grade, then packed in an aluminum foil bag with vacuum heat-sealed and nitrogen protection, lastly placed in a fiber drum and well-closed.
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China