Product details
WHO Product ID
WHOAPI-418
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Isoniazid
Confirmation of WHO API prequalification document (version date)
Applicant organization
Anuh Pharma Ltd.
E17/3 & 17/4 & E-18 MIDC, Tarapur Boisar Dist. Palghar
Maharashtra
401 506
India
APIMF Version Number
Anuh/Isoniazid/Applicant part/00/11-20/Amend-02-December-2024
Anuh/Isoniazid/Restricted part/00/11-20/Amend-02-December-2024
Anuh/Isoniazid/Restricted part/00/11-20/Amend-02-December-2024
Product Grades
API specification number
FPS/WHOIZ/094 - Version 00
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Primary packaging material: double polyethylene bag
Secondary packaging material: Opaque HDPE drum or fibre drum
Secondary packaging material: Opaque HDPE drum or fibre drum
API Manufacturing Site(s)
Anuh Pharma Ltd.
E17/3 & 17/4 & E-18 MIDC, Tarapur Boisar Dist. Palghar
Maharashtra
401 506
India