Product Details
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
Blister, Alu/Alu
Configuration
14x24
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
1000x1
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from light
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
Aurangabad,
431 210
India