Product details
WHO Product ID
WHOAPI-471
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
Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.
Room 350, No.25 Kangshi Road, Kangqiao Town Pudong New District (Kangqiao)
Shanghai
201315
China
APIMF Version Number
Fosun Pharma./Nirmatrelvir /OP/01/March-2024
Fosun Pharma./Nirmatrelvir /RP/01/March-2024
Fosun Pharma./Nirmatrelvir /RP/01/March-2024
Product Grades
API specification number
TS-QA-B52-001-9
Storage condition
Do not store above 30°C
Storage period (months)
24
Duration type
Retest period
Packaging
The material is primarily placed into double PE bag, heat seal; then placed into an aluminium foil bag and heat seal, finally place into the fiber drum.
API Manufacturing Site(s)
Chongqing Carelife Pharmaceutical Co., Ltd.
No. 2, The Third Branch Road, Huanan Road
Yan Jia, Changshou District,
Chongqing
401221
China