Product details
WHO Product ID
WHOAPI-467
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Covid-19
Type
None
Grade
Standard
INN
Nirmatrelvir
Confirmation of WHO API prequalification document (version date)
Applicant organization
Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd
333 Jiangnan Road, Hengdian
Dongyang,
Zhejiang
322 118
China
APIMF Version Number
KYP-NMT-AP-01/202306
KYP-NMT-RP-01/202306
KYP-NMT-RP-01/202306
Product Grades
API specification number
SOP-QC-1008Z-02-S
Storage condition
Do not store above 30°C
Storage period (months)
12
Duration type
Retest period
Packaging
Primary packaging: double colorless/transparent polyethylene bags (LDPE), closed tightly with bag ties.
Secondary packaging: fiberboard drum.
Secondary packaging: fiberboard drum.
API Manufacturing Site(s)
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd
333, Second Jiangnan Road, Hengdian
Dongyang,
Zhejiang
China