Product details
WHO Product ID
WHOAPI-197
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
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
APIMF Version Number
LL/ETHAMBUTOL HCl/AP/02/2012-06-25
LL/ETHAMBUTOL HCl/RP/02/2012-06-25
LL/ETHAMBUTOL HCl/RP/02/2012-06-25
Product Grades
API specification number
API 318380 version No. 03
Storage condition
Do not store above 30°C
Storage period (months)
36
Duration type
Retest period
Packaging
Double LDPE bags with silica gel pouch between the outer LDPE bag and fibre drum/HDPE drum. The outer bag is twist and tie and further placed in an HDPE drum container or in a fiber drum container.
API Manufacturing Site(s)
Lupin Ltd
Plot No. 09, 123, 123/1, 124 & 125 -Ethambutol (ETB) Plant, GIDC Estate
Ankleshwar,
Gujarat
393 002
India