Medicines/finished pharmaceutical products

Reference Number: 
TB009

Date of prequalification: 
28 April 2010
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethambutol hydrochloride/Isoniazid
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 400mg/150mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC/PVdC: 10x10, 28x14, 28x24
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: 

(Isoniazid) Amsal Chem Pvt Ltd, A-1/401-402-403 GIDC Area, Ankleshwar, Bharuch District, Gujarat, 393 002, India
(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