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Product Details
WHO Product ID
TB177
Status
Prequalified
INN, dosage form and strength
Ethambutol hydrochloride Tablet, Film-coated 400mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
Packaging details and storage conditions
Packaging Type
Blister, Al/PVC/PVdC
Configuration
10x10, 28x24
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Lupin Ltd
Plot No. 09, 123, 123/1, 124 & 125 -Ethambutol (ETB) Plant, GIDC Estate
Ankleshwar,
Gujarat
393 002
India
Ethambutol hydrochloride
FPP Manufacturing Site(s)
Lupin Ltd
EPIP, SIDCO Industrial Complex, Kartholi
Bari Brahmana,
Jammu and Kashmir
181 133
India
Lupin Ltd
A-28/1 MIDC Industrial Area, Chikalthana
Aurangabad,
431 210
India