Product details
WHO Product ID
WHOAPI-040
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Pyrazinamide
Confirmation of WHO API prequalification document (version date)
Applicant organization
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
APIMF Version Number
LL/PYRAZINAMIDE/AP/06/2010-04-07
LL/PYRAZINAMIDE/RP/05/2010-04-07
Amendment 01-March 2022
Amendment 01-October 2023
Amendment 02-November 2023
Amendment 01-February 2025
LL/PYRAZINAMIDE/RP/05/2010-04-07
Amendment 01-March 2022
Amendment 01-October 2023
Amendment 02-November 2023
Amendment 01-February 2025
Product Grades
API specification number
API 319779-01-05
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
48
Duration type
Retest period
Packaging
The material is packed in inner LDPE polybag which is strap sealed and is placed in outer LDPE polybag which is further heat sealed. It is then packed in HMHDPE.
API Manufacturing Site(s)
Lupin Manufacturing Solutions Ltd.
Plot No. 130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli
Andhra Pradesh
531019
India