Product details
WHO Product ID
WHOAPI-457
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
Aurobindo Pharma Ltd
Plot No 2, Maitrivihar, Ameerpet
Hyderabad,
Telangana
500 038
India
APIMF Version Number
Molnupiravir/OP-00/April-2022
Molnupiravir/RP-00/April-2022
Molnupiravir/OP-00/April-2022 Update/08-2022
Molnupiravir/RP-00/April-2022 Update/08-2022
Molnupiravir/OP-00/April-2022 Update/02-2023
Molnupiravir/RP-00/April-2022 Update/02-2023
Molnupiravir/OP-00/April-2022 Update/05-2023
Molnupiravir/RP-00/April-2022 Update/05-2023
Molnupiravir/RP-00/April-2022
Molnupiravir/OP-00/April-2022 Update/08-2022
Molnupiravir/RP-00/April-2022 Update/08-2022
Molnupiravir/OP-00/April-2022 Update/02-2023
Molnupiravir/RP-00/April-2022 Update/02-2023
Molnupiravir/OP-00/April-2022 Update/05-2023
Molnupiravir/RP-00/April-2022 Update/05-2023
Product Grades
API specification number
NSFP01710A-06
Storage condition
Do not store above 30°C
Storage period (months)
12
Duration type
Retest period
Packaging
Molnupiravir packed under nitrogen atmosphere, is placed in a transparent low-density polyethylene (LDPE) bag, which is closed with a twist tie with a plastic fastener. This bag is inserted in a second transparent LDPE bag, which is heat sealed after nitrogen purge, and further placed in a triple laminate (Polyethylene terephthalate/Aluminum foil/ linear LDPE) bag, which is also heat sealed after nitrogen purge. This pack is finally placed in a well-closed high-density polyethylene (HDPE) container after nitrogene purge.
API Manufacturing Site(s)
Aurobindo Pharma Limited
Unit-XIV Plot No. 17, Jawaharlal Nehru Pharma City, E-Bonangi Village
Parawada Mandal, Anakapalli District,
Andhra Pradesh
531019
India