Product details
WHO Product ID
WHOAPI-105
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Ethionamide
Confirmation of WHO API prequalification document (version date)
Applicant organization
Pen Tsao Chemical Industry Ltd
27B, CKK Commercial Centre, 289 Hennessy Road, Wanchai
Hong Kong,
China
APIMF Version Number
APIMF 105/OP-Version 10/June 2020
APIMF 105/RP- Version 10/June 2020
Amendment 01 - May 2021
APIMF 105/RP- Version 10/June 2020
Amendment 01 - May 2021
Product Grades
API specification number
QC-20-A1190EPW, version 18
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
60
Duration type
Retest period
Packaging
Primary Packing material: Double polyethylene bags, twist tied. Outer packaging: Fibre drum
API Manufacturing Site(s)
Pen Tsao Chemical & Pharmaceutical Industry Ltd
No 2 Teili Road, Wusong, Baoshan District
Yanghang Town,
Shanghai
200 940
China