Product details
WHO Product ID
WHOAPI-168
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Isoniazid
Confirmation of WHO API prequalification document (version date)
Applicant organization
Second Pharma Co Ltd
No. 33, Weiwu Road, Hangzhou Gulf Fine Chemical Zone
Shangyu,
Zhejiang
312 369
China
APIMF Version Number
Second Pharma Co., Ltd./Isoniazid/OP/006 /2021-05-10
Second Pharma Co., Ltd./Isoniazid/RP/006 /2021-05-10
Second Pharma Co., Ltd/Isoniazid/OP/006/2021-05-10/Amend 01-January-2023
Second Pharma Co., Ltd./Isoniazid/RP/006 /2021-05-10
Second Pharma Co., Ltd/Isoniazid/OP/006/2021-05-10/Amend 01-January-2023
Product Grades
API specification number
SP-API-061-16
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Primary packaging: LDPE bag; Secondary packaging: black plastic bag; Tertiary packaging: Fibre drum
API Manufacturing Site(s)
Second Pharma Co Ltd
No. 33, Weiwu Road, Hangzhou Gulf Fine Chemical Zone
Shangyu,
Zhejiang
312 369
China