药品/药物成品

Reference Number: 
TB008

Date of prequalification: 
13 November 2003
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethambutol hydrochloride
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, coated 400mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC:10x10; BlisterAlu/PVC/PVdC:28x24; Bottle HDPE:1000x1
Applicant: 
Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India
FPP Manufacturing Site: 

Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Ethambutol hydrochloride) Cadila Pharmaceuticals Ltd, 294 GIDC Industrial Estate, Ankleshwar, 393 002, India
(Ethambutol hydrochloride) Lupin Ltd, Plant 1 -Ethambutol (ETB) Plant, Plot 124 GIDC Estate, Ankleshwar, Gujarat, 393 002, India