Medicines/finished pharmaceutical products

Reference Number: 
TB334

Date of prequalification: 
14 March 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethambutol hydrochloride
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Dispersible 100mg
Storage condition: 
Do not store above 30°C, store in dry condition, protect from light
Shelf life (months): 
24 (Alu-PVC/PE/PVdC blister); 36 (Alu strip)
Packaging: 
Blister,Alu-PVC/PE/PVdC 10x10; Strip,Alu/Alu 6x10; 10x8
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
Oxalis Labs, Vill. Theda, P.O.lodhimajra, Baddi, Distt. Solan, India

API Manufacturing Site: 

(Ethambutol hydrochloride) Lupin Ltd, Plot No. 09, 123, 123/1, 124 & 125 -Ethambutol (ETB) Plant, GIDC Estate, Ankleshwar 393 002, Gujarat, India