Product details
WHO Product ID
WHOAPI-458
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Covid-19
Grade
Standard
INN
Nirmatrelvir
Confirmation of WHO API prequalification document (version date)
Applicant organization
Zhejiang Jiuzhou Pharmaceutical Co, Ltd
99 Waisha Road Jiaojiang District
Taizhou City,
Zhejiang
318000
China
APIMF Version Number
Nirmatrelvir/OP/04/Apr-2023
Nirmatrelvir/RP/03/Apr-2023
Nirmatrelvir/OP/04/Apr-2023/Amend 01 – Jun-2023
Nirmatrelvir/RP/03/Apr-2023
Nirmatrelvir/OP/04/Apr-2023/Amend 01 – Jun-2023
Product Grades
API specification number
WQTP-SPR-2571-02, Version No. 4.0
Storage condition
Do not store above 30°C
Storage period (months)
24
Duration type
Retest period
Packaging
Primary packaging: double low-density polyethylene (LDPE) bags.
Secondary packaging: high density polyethylene (HDPE) drum.
Secondary packaging: high density polyethylene (HDPE) drum.
API Manufacturing Site(s)
Zhejiang Jiuzhou Pharmaceutical Co, Ltd
99 Waisha Road Jiaojiang District
Taizhou City,
Zhejiang
318000
China