Product details
WHO Product ID
WHOAPI-551
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
Resonance Specialities Limited
54-D Kandivli Industrial Estate, Charkop Kandivli West
Mumbai,
Maharashtra
400067
India
APIMF Version Number
Resonance/Pyrazinamide/OP/00/2025-12-10
Resonance/Pyrazinamide/RP/00/2025-12-10
Resonance/Pyrazinamide/RP/00/2025-12-10
Product Grades
API specification number
FP/S/038-R07
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
30
Duration type
Retest period
Packaging
Primary packing: transparent Low-density polyethylene (LDPE)
Secondary packing: transparent Low-density polyethylene (LDPE)
Outer pack: HMHDPE-drum
Secondary packing: transparent Low-density polyethylene (LDPE)
Outer pack: HMHDPE-drum
API Manufacturing Site(s)
Kaygee Laboratories Private Limited
Plot No. 06, Block No. - III Phase II, New Industrial Area
Mandideep, Raisen,
Madhya Pradesh
462046
India