Medicines/finished pharmaceutical products

Reference Number: 
TB134

Date of prequalification: 
23 March 2007
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethambutol hydrochloride
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 400mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC/PVdC: 10x9,10x10, 28x24; HDPE Bottle: 1000x1
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 210, India

API Manufacturing Site: 

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