Product details
WHO Product ID
WHOAPI-412
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Covid-19
Grade
Standard
INN
Dexamethasone (sodium phosphate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Tianjin Tianyao Pharmaceuticals Co., Ltd
No.19 Xin Ye 9th street
Tianjin
300462
China
APIMF Version Number
Tianjin Tianyao/Dexamethasone sodium phosphate/OP/01/2020-12-14
Tianjin Tianyao/Dexamethasone sodium phosphate/RP/01/2020-12-14
Tianjin Tianyao/Dexamethasone sodium phosphate/RP/01/2020-12-14
Product Grades
API specification number
SP-QCDNa22 Version 03
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Polyethylene bag sealed by a plastic locking tie, then put in an aluminium can, sealed mechanically.
API Manufacturing Site(s)
Tianjin Tianyao Pharmaceuticals Co., Ltd
No.19 Xin Ye 9th street
Tianjin
300462
China