Product details
WHO Product ID
WHOAPI-158
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
Anuh Pharma Ltd
E17/3 & 17/4 & E-18 MIDC, Boisar Tarapur Taluka-Palghar, Thane District
Maharashtra
401 506
India
APIMF Version Number
ANUH/PYRAZINAMIDE/APPLICANT PART/26/10-21
ANUH/PYRAZINAMIDE/RESTRICTED PART/26/10-21
ANUH/PYRAZINAMIDE/RESTRICTED PART/26/10-21
Product Grades
API specification number
STP/WHOPZ/003-02
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Double colourless polyethylene bags placed in HDPE/fibre drums
API Manufacturing Site(s)
Anuh Pharma Ltd
E17/3 & 17/4 & E-18 MIDC, Boisar Tarapur Taluka-Palghar, Thane District
Maharashtra
401 506
India