Product Details
WHO Product ID
TB134
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
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
10x9, 10x10, 28x24
Shelf life (months)
48
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
1000x1
Shelf life (months)
48
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)
Macleods Pharmaceuticals Ltd
Unit 2, Phase II, III and IV, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India