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, Boisar Tarapur Taluka-Palghar, Thane District
Maharashtra
401 506
India
APIMF Version Number
ANUH/ISONIAZID/APPLICANT PART/00/11-20
ANUH/ISONIAZID/RESTRICTED PART/00/11-20
ANUH_ISONIAZID_APPLICANT PART_00_11-20-AMEND-01-AUGUST 2021
ANUH_ISONIAZID_RESTRICTED PART_00_11-20-AMEND-01-AUGUST 2021
ANUH/ISONIAZID/APPLICANT PART/00_11-20/AMEND-02-FEBRUARY 2022
ANUH/ISONIAZID/RESTRICTED PART/00/11-20-AMEND-02-FEBRUARY 2022
ANUH/ISONIAZID/APPLICANT PART/00/11-20-AMEND-03-OCTOBER 2022
ANUH/ISONIAZID/RESTRICTED PART/00/11-20-AMEND-03-OCTOBER 2022
ANUH/ISONIAZID/RESTRICTED PART/00/11-20
ANUH_ISONIAZID_APPLICANT PART_00_11-20-AMEND-01-AUGUST 2021
ANUH_ISONIAZID_RESTRICTED PART_00_11-20-AMEND-01-AUGUST 2021
ANUH/ISONIAZID/APPLICANT PART/00_11-20/AMEND-02-FEBRUARY 2022
ANUH/ISONIAZID/RESTRICTED PART/00/11-20-AMEND-02-FEBRUARY 2022
ANUH/ISONIAZID/APPLICANT PART/00/11-20-AMEND-03-OCTOBER 2022
ANUH/ISONIAZID/RESTRICTED PART/00/11-20-AMEND-03-OCTOBER 2022
Product Grades
API specification number
FPS/IZ/004-06
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
24
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, Boisar Tarapur Taluka-Palghar, Thane District
Maharashtra
401 506
India