Product details
WHO Product ID
WHOAPI-093
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/03/2009-03-04
LL/ETHAMBUTOL HCl/RP/03/2009-03-04
LL/ETHAMBUTOL HCl/RP/03/2009-03-04
Product Grades
API specification number
API 303622-01-05
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
36
Duration type
Retest period
Packaging
Inner LDPE bag enclosed in a HMHDPE/LDPE/LLDPE bag with silica sachet, outer aluminium bag, housed within Fibre or HMHDP drums
API Manufacturing Site(s)
Lupin Ltd
T-142, M.I.D.C, Thane District
Tarapur, Via Boisar,
Maharashtra
401 506
India