Product details
WHO Product ID
WHOAPI-477
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
Tianish Laboratories Private Limited
Plot No. 564/A/22, Road No. 92, Jubilee Hills, Filmnagar, Shaikpet
Hyderabad,
Telangana
500096
India
APIMF Version Number
MLL/MOL/AP/001/01, March 2024
MLL/MOL/RP/001/01, March 2024
MLL/MOL/AP/001/01, March 2024; Amend-02, June 2024
MLL/MOL/RP/001/01, March 2024; Amend-02, June 2024
MLL/MOL/RP/001/01, March 2024
MLL/MOL/AP/001/01, March 2024; Amend-02, June 2024
MLL/MOL/RP/001/01, March 2024; Amend-02, June 2024
Product Grades
API specification number
STP/FPR/MOL/002/02
Storage condition
Do not store above 30°C
Storage period (months)
24
Duration type
Retest period
Packaging
Molnupiravir is packed in Transparent polyethylene bags (LDPE) bag flushed with nitrogen, twist and tied with plastic fastener. It is then inserted in HMLDPE Bag (Transparent) and Heat sealing. Both these bags are then put into the outer bag of Triple laminated aluminum bag (inside black color) and Heat sealing. Such poly bags are further packed in HDPE drums, closed with plastic lids having rubber gasket followed by locking ring, seal and labelled.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India