Product details
WHO Product ID
WHOAPI-422
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
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
APIMF Version Number
MLL/Ethionamide/OP-01/February-2023
MLL/Ethionamide/RP-01/February-2023
MLL/Ethionamide/RP-01/February-2023
Product Grades
API specification number
FPSPPI218 Revision 04
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
24
Duration type
Retest period
Packaging
Primary packing: double transparent polyethylene (LDPE) bag.
Secondary packing: HDPE container.
Secondary packing: HDPE container.
API Manufacturing Site(s)
Micro Labs Limited
API - Division (ML-15), Plot No.43-45, KIADB, Jigani-Bommasandra Link Road, Anekal Taluk
Bengaluru,
Karnataka
560 105
India