Product details
WHO Product ID
WHOAPI-040
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
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
LL / PYRAZINAMIDE / RP/ 05 / 2010-04-07 Amendment 01-March 2022
Product Grades
API specification number
API 300942-02-14 (Tarapur) and API 319779-01-05 (Visakhapatnam)
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 poly-bag which is strap sealed and is placed in outer LDPE poly-bag which is further heat sealed. It is then packed in HMHDPE.
API Manufacturing Site(s)
Lupin Ltd
T-142, M.I.D.C, Thane District
Tarapur, Via Boisar,
Maharashtra
401 506
India
Lupin Limited
Plot No. 130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli
Andhra Pradesh
531019
India