Product Details
WHO Product ID
TB231
Status
Prequalified
INN, dosage form and strength
Isoniazid/Rifampicin Tablet, Film-coated 150mg/300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Sachet, PET/Alu/LLDPE packed HDPE container
Configuration
500x1, 1000x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, store in dry condition, protect from light
Packaging Type
Blister, PVC/PVdC/Alu
Configuration
10x10, 28x3, 28x24
Shelf life (months)
24
Storage conditions
Do not store above 25°C, store in dry condition, 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
Second Pharma Co Ltd
No. 33, Weiwu Road, Hangzhou Gulf Fine Chemical Zone
Shangyu,
Zhejiang
312 369
China
Isoniazid
Shenyang Antibiotic Manufacturer (Suspended)
Jianshebei 3 Road, Hushitai Town, Xinchengzi District
Shenyang,
Liaoning
110 122
China
Rifampicin
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Unit 2, Phase II, III and IV, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India
Oxalis Labs
Vill. Theda, Baddi, Distt. Solan
P.O.lodhimajra,
174101
India