Product details
WHO Product ID
WHOAPI-108
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Efavirenz
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/Efavirenz/OP/0004/2021-10
Desano-B/Efavirenz/RP/0004/2021-10
Desano-B/Efavirenz/RP/0004/2021-10
Product Grades
API specification number
SOP-B-QC-170-19
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
The primary package of Efavirenz consists of two bags: inner bag and outer bag. The inner bag is pharmaceutical grade low-density transparent polyethylene (LDPE) bag which is placed in the pharmaceutical grade LDPE bag (outer bag). Both bags are tied separately with LDPE fastener and placed in a fibre drum.
API Manufacturing Site(s)
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China