Product details
WHO Product ID
WHOAPI-078
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
Calyx Chemicals & Pharmaceuticals Ltd
A-37, 38 Kalyan Shill Road, MIDC Phase-I, Golvali, Thane District
Dombivli,
Maharashtra
421 203
India
APIMF Version Number
Calyx/Pyrazinamide/OP/03/Oct-2018
Calyx/Pyrazinamide/RP/03/Oct-2018
Calyx/Pyrazinamide/RP/03/Oct-2018
Product Grades
API specification number
SP/FP/68 rev 12
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Dual HMHDPE/LDPE translucent bags within a HPDE drum.
API Manufacturing Site(s)
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India