Product Details
WHO Product ID
TB192
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
Svizera Europe BV
Antennestraat 43
AH Almere,
1320
Netherlands
Packaging details and storage conditions
Packaging Type
Blister, Al/PVdC
Configuration
28x24
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from moisture, protect from light
Packaging Type
Bottle, HDPE
Configuration
1000x1
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from moisture, 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
Olon Active Pharmaceutical Ingredients India Private Limited
Plot No: L-1, L-21 to L-28 & L-44, Additional Phase MIDC, Raigad District
Mahad,
Maharashtra
402 301
India
Rifampicin
Shenyang Antibiotic Manufacturer (Suspended)
Jianshebei 3 Road, Hushitai Town, Xinchengzi District
Shenyang,
Liaoning
110 122
China
Rifampicin
FPP Manufacturing Site(s)
Svizera Labs Pvt. Ltd.
Plot No D16/6 TTC Industrial Area, MIDC, Turbhe
Navi Mumbai,
400 703
India