Product details
WHO Product ID
WHOAPI-202
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Emtricitabine
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/Emtricitabine/OP/0004/2020-10
Desano-B/Emtricitabine/RP/0004/2020-10
Amendment 01
Amendment 02
Amendment 03
Amendment 04
Desano-B/Emtricitabine/RP/0004/2020-10
Amendment 01
Amendment 02
Amendment 03
Amendment 04
Product Grades
API specification number
SOP-B-QC-165-22
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Emtricitabine is packed by two pharmaceutical grade low density polyethylene(LDPE) bags, which are tied separately with plastic slide fastener, and placed in aluminum foil bag and closed with heat-seal; then enclosed 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