Product Details
WHO Product ID
TB223
Status
Prequalified
INN, dosage form and strength
Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Strip, Alu/Alu
Configuration
10x10, 28x24
Shelf life (months)
36
Storage conditions
Do not store above 25°C, store in dry condition, protect from light
Packaging Type
Bottle, HDPE
Configuration
500x1
Shelf life (months)
36
Storage conditions
Do not store above 25°C, store in dry condition, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India
Isoniazid, Pyrazinamide
Micro Labs Limited
API - Division (ML-15), Plot No.43-45, KIADB, Jigani-Bommasandra Link Road, Anekal Taluk
Bengaluru,
Karnataka
560 105
India
Ethambutol hydrochloride
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)
Micro Labs Limited
ML08, Plot No 15/A, 2nd Phase, Kumbalgodu Industrial Area
Bangalore,
560 074
India