Product details
WHO Product ID
WHOAPI-437
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
Aurore Life Sciences Private Limited
Plot No. 68, 69, 2nd Floor, Jubilee Heights, Hitech City, Near Shilparamam
Madhapur, Hyderabad,
Telangana
500081
India
APIMF Version Number
Aurore/Molnupiravir/OP/01/January-2023
Aurore/Molnupiravir/RP/01/January-2023
ALSPL/APLU/AP-CTD/01/2023-January/AM01/2024-May
ALSPL/APLU/RP-CTD/01/2023-January/AM01/2024-May
Aurore/Molnupiravir/RP/01/January-2023
ALSPL/APLU/AP-CTD/01/2023-January/AM01/2024-May
ALSPL/APLU/RP-CTD/01/2023-January/AM01/2024-May
Product Grades
API specification number
APLU/STP/FP/005/07
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
36
Duration type
Retest period
Packaging
Clear translucent polythene bag (HDPE) twist and tied with plastic fastener under nitrogen atmosphere, placed in black color low-density polyethylene bag and twist and tied with plastic fastener. This double polyethylene bag is placed inside a triple laminated bag and then this triple laminated bag is heat sealed and kept this bag inside a HDPE container, sealed and label the container.
API Manufacturing Site(s)
Aurore Life Sciences Private Limited
Plot No. 180/2 & 3 Khazipally (V), Jinnaram (M) Sangareddy District
Telangana
502319
India