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/04/APR-2025
AMSAL/Isoniazid/RP/04/APR-2025
AMSAL/Isoniazid/RP/04/APR-2025
Product Grades
API specification number
STP/QC/138 version 04 (USP standard)
Storage condition
Do not store above 30°C, protect from moisture
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