WHO Product ID
TB199
Status
Prequalified
INN, dosage form and strength
Ethambutol hydrochloride/Isoniazid/Rifampicin Tablet, Film-coated 275mg/75mg/150mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
1000x1
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from light
Packaging Type
Blister, Alu/Alu
Configuration
14x24
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Al/PVC/PVdC
Configuration
28x24
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from light
Packaging Type
Blister Alu/PVC/PE/PVdC
Configuration
28x24
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Amsal Chem Pvt Ltd
A-1/401-402-403 GIDC Area, Bharuch District
Ankleshwar,
Gujarat
393 002
India
Isoniazid
Lupin Ltd
Plot No. 09, 123, 123/1, 124 & 125 -Ethambutol (ETB) Plant, GIDC Estate
Ankleshwar,
Gujarat
393 002
India
Ethambutol hydrochloride
Lupin Ltd.
T-142, M.I.D.C, Thane District
Tarapur, Via Boisar,
Maharashtra
401 506
India
Rifampicin
FPP Manufacturing Site(s)
Lupin Ltd
A-28/1 MIDC Industrial Area, Chikalthana
Chhatrapati Sambhajinagar,
431 210
India
