Product details
WHO Product ID
WHOAPI-483
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
DongBang Future Tech & Life Co., Ltd.
78, Jeyakgongdan 4-gil, Hyangnam-eup
Hwaseong-si, Gyeonggi-do,
18622
Republic of Korea
APIMF Version Number
Nirmatrelvir/OP/00/Feb-2023
Nirmatrelvir/RP/00/Feb-2023
Nirmatrelvir/RP/00/Feb-2023
Product Grades
API specification number
Version No. 5.0
Storage condition
Do not store above 30°C
Storage period (months)
24
Duration type
Retest period
Packaging
Primary packaging: Double transparent polyethylene bags.
Secondary packaging: Fiber drum.
Secondary packaging: Fiber drum.
API Manufacturing Site(s)
DongBang Future Tech & Life Co., Ltd.
78, Jeyakgongdan 4-gil, Hyangnam-eup
Hwaseong-si, Gyeonggi-do,
18622
Republic of Korea