药品/药物成品

Reference Number: 
TB177

Date of prequalification: 
08 April 2010
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, store in dry condition
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 100x1, 500x1, 1000x1; Blister Alu/PVC/PVdC\: 10X10, 28X24
Applicant: 
Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India
FPP Manufacturing Site: 

Lupin Ltd, Rifa & Non-Rifa Facilities, Block No 1 & 2, A-28/1 MIDC Industrial Area, Chikalthana, Aurangabad, 431 210, India
Lupin Ltd, EPIP, SIDCO Industrial Complex, Kartholi, Bari Brahmana, Jammu & Kashmir, 181 133, India

API Manufacturing Site: 

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