Product details
WHO Product ID
WHOAPI-005b
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
Amsal Chem Pvt Ltd
A-1/401-402-403 GIDC Area, Bharuch District
Ankleshwar,
Gujarat
393 002
India
APIMF Version Number
AMSAL/ISONIAZID/OP/03/AUG-2020
AMSAL/ISONIAZID/RP/03/AUG-2020
AMSAL/ISONIAZID/OP/03/AUG-2020/AMEND01-NOV-2021
AMSAL/ISONIAZID/RP/03/AUG-2020/AMEND01-NOV-2021
AMSAL/ISONIAZID/OP/03/AUG-2020/AMEND02-FEB-2023
AMSAL/ISONIAZID/RP/03/AUG-2020/AMEND02-FEB-2023
AMSAL/ISONIAZID/OP/03/AUG 2020/AMEND03-DEC-2023
AMSAL/ISONIAZID/RP/03/AUG-2020/AMEND03-DEC-2023
AMSAL/ISONIAZID/OP/03/AUG-2020/AMEND03-APR-2024
AMSAL/ISONIAZID/RP/03/AUG-2020/AMEND03-APR-2024
AMSAL/ISONIAZID/RP/03/AUG-2020
AMSAL/ISONIAZID/OP/03/AUG-2020/AMEND01-NOV-2021
AMSAL/ISONIAZID/RP/03/AUG-2020/AMEND01-NOV-2021
AMSAL/ISONIAZID/OP/03/AUG-2020/AMEND02-FEB-2023
AMSAL/ISONIAZID/RP/03/AUG-2020/AMEND02-FEB-2023
AMSAL/ISONIAZID/OP/03/AUG 2020/AMEND03-DEC-2023
AMSAL/ISONIAZID/RP/03/AUG-2020/AMEND03-DEC-2023
AMSAL/ISONIAZID/OP/03/AUG-2020/AMEND03-APR-2024
AMSAL/ISONIAZID/RP/03/AUG-2020/AMEND03-APR-2024
Product Grades
API specification number
STP/QC/138 version 04 (USP standard)
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Shelf life
Packaging
Double PE bags inside Fibre board drums or HDPE drums
API Manufacturing Site(s)
Amsal Chem Pvt Ltd
A-1/401-402-403 GIDC Area, Bharuch District
Ankleshwar,
Gujarat
393 002
India