Product details
WHO Product ID
WHOAPI-439
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Covid-19
Type
None
Grade
Standard
INN
Molnupiravir
Confirmation of WHO API prequalification document (version date)
Applicant organization
Emcure Pharmaceuticals Limited
Plot No. P1 & P2, I.T.B.T. Park Phase II., M.I.D.C., Hinjawadi
Pune,
Maharashtra
411057
India
APIMF Version Number
Emcure/Molnupiravir/OP/01/NOV-2022
Emcure/Molnupiravir/RP/01/NOV-2022
Emcure/Molnupiravir/OP/01/NOV-2022/Amend-01-JAN-2023
Emcure/Molnupiravir/RP/01/NOV-2022/Amend-01-JAN-2023
Emcure/Molnupiravir/OP/01/NOV-2022/Amend-02-APR-2023
Emcure/Molnupiravir/OP/01/NOV-2022/Amend-03-JUN-2024
Emcure/Molnupiravir/RP/01/NOV-2022/Amend-02-JUN-2024
Emcure/Molnupiravir/RP/01/NOV-2022
Emcure/Molnupiravir/OP/01/NOV-2022/Amend-01-JAN-2023
Emcure/Molnupiravir/RP/01/NOV-2022/Amend-01-JAN-2023
Emcure/Molnupiravir/OP/01/NOV-2022/Amend-02-APR-2023
Emcure/Molnupiravir/OP/01/NOV-2022/Amend-03-JUN-2024
Emcure/Molnupiravir/RP/01/NOV-2022/Amend-02-JUN-2024
Product Grades
API specification number
SC-DS-632/01
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
6
Duration type
Retest period
Packaging
antistatic LDPE transparent bag in black LDPE bag + aluminium polylaminated bag
API Manufacturing Site(s)
Emcure Pharmaceuticals Ltd
Plot no. D-24 &D24/1, MIDC Kurkumbh Industrial Area, Daund, Pune District
Maharashtra
413802
India