Product details
WHO Product ID
WHOAPI-086
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
Calyx Chemicals & Pharmaceuticals Ltd
A-37, 38 Kalyan Shill Road, MIDC Phase-I, Golvali, Thane District
Dombivli,
Maharashtra
421 203
India
APIMF Version Number
CCPL/Isoniazid/OP/02/Mar-2020
CCPL/Isoniazid/RP/02/Mar-2020
Amendment 01 Sep-2020
Amendment 02 Jan-2023
CCPL/Isoniazid/RP/02/Mar-2020
Amendment 01 Sep-2020
Amendment 02 Jan-2023
Product Grades
API specification number
SP/FP/73 Rev 09
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
HMHDPE translucent or LDPE transparent bag placed in HMHDPE or LDPE black bag and then in an HDPE drum
API Manufacturing Site(s)
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India