Product details
WHO Product ID
WHOAPI-449
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Covid-19
Grade
Standard
INN
Molnupiravir
Confirmation of WHO API prequalification document (version date)
Applicant organization
Shanghai Desano Chemical Pharmaceutical Co Ltd
1479 Zhangheng Road, Zhangjiang Hi-Tech Park, Pudong
Shanghai,
201 203
China
APIMF Version Number
Desano-B/Molnupiravir/APIMF/OP/0001/2023-07
Desano-B/Molnupiravir/APIMF/RP/0001/2023-07
Desano-B/Molnupiravir/APIMF/RP/0001/2023-07
Product Grades
API specification number
SOP-B-QC-1408-06
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
24
Duration type
Retest period
Packaging
The product is packed in a pharmaceutical grade low density polyethylene (LDPE) bag (inner bag), contained in a second pharmaceutical grade low density polyethylene (LDPE) bag. Both the inner bags and outer bags are tied separately with a LDPE fastener. Then the product in double layer LDPE bags is packed with aluminum foil bag, heat sealed. Finally, the product is packed in a fibre drum.