Product details
WHO Product ID
WHOAPI-481b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Covid-19
Type
None
Grade
Micronized
INN
Nirmatrelvir
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/NIR/AP/001/01, March 2024
MLL/NIR/RP/001/01, March 2024
MLL/NIR/AP/001/01, March 2024; Amend-01, June 2024
MLL/NIR/RP/001/01, March 2024; Amend-01, June 2024
MLL/NIR/RP/001/01, March 2024
MLL/NIR/AP/001/01, March 2024; Amend-01, June 2024
MLL/NIR/RP/001/01, March 2024; Amend-01, June 2024
Product Grades
API specification number
STP/FPR/NIR/001/02
Storage condition
Do not store above 30°C
Storage period (months)
24
Duration type
Retest period
Packaging
Nirmatrelvir is first packed in Transparent Polyethylene bag (LDPE) flushed with nitrogen, twisted and tied with a plastic fastener. It is then inserted in Transparent Polyethylene bag (HMLDPE) and heat sealed. Both these bags are then put into the outer bag of Triple laminated aluminum bag and heat sealed. These bags are further packed in HDPE drums and tightly 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