Product details
WHO Product ID
WHOAPI-464b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Covid-19
Type
None
Grade
Micronized
INN
Nirmatrelvir
Confirmation of WHO API prequalification document (version date)
Applicant organization
Zhejiang Huahai Pharmaceutical Co. Ltd.
Xunqiao
Linhai,
Zhejiang
317 024
China
APIMF Version Number
WHO-01.5, Date: 2023-08-01
WHO-01.5, Date: 2023-08-01
WHO-01.5, Date: 2023-08-01
Product Grades
API specification number
QS-A859-01.06
Storage condition
Do not store above 30°C
Storage period (months)
12
Duration type
Retest period
Packaging
Nirmatrelvir drug substance is packed in a polyethylene bag (colorless & translucent), sealed using a polyethylene tie, then put into a complex aluminum film (aluminum foil and polyethylene), vacuumed and then flushed with nitrogen between polyethylene bag and complex aluminum film, finally placed in fiber drum.
API Manufacturing Site(s)
Zhejiang Huahai Pharmaceutical Co. Ltd.
Costal Industrial Zone, Duqiao
Linhai,
Zhejiang
317 016
China