Product Details
WHO Product ID
TB189
Status
Prequalified
INN, dosage form and strength
Isoniazid/Rifampicin Tablet, Film-coated 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/PVC/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
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India
Isoniazid
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