Product details
WHO Product ID
WHOAPI-273
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Ethambutol hydrochloride
Confirmation of WHO API prequalification document (version date)
Applicant organization
Micro Labs Limited
API - Division (ML-15), Plot No.43-45, KIADB, Jigani-Bommasandra Link Road, Anekal Taluk
Bengaluru,
Karnataka
560 105
India
APIMF Version Number
MLL/EHA/APIMF/AP/03, October-2021
MLL/EHA/APIMF/RP/03, October-2021
MLL/EHA/APIMF/AP/03, October-2021/Amend 01-March-2023
MLL/EHA/APIMF/RP/03, October-2021/Amend 01-March-2023
MLL/EHA/APIMF/RP/03, October-2021/Amed-02, May-2023
MLL/EHA/APIMF/RP/03, October-2021
MLL/EHA/APIMF/AP/03, October-2021/Amend 01-March-2023
MLL/EHA/APIMF/RP/03, October-2021/Amend 01-March-2023
MLL/EHA/APIMF/RP/03, October-2021/Amed-02, May-2023
Product Grades
API specification number
FPSPUS086 revision number 07
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Ethambutol hydrochloride is packed in LDPE transparent bag, secondary outer black LDPE bag and triple laminated aluminum bags and HDPE drums.
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