Medicines/finished pharmaceutical products

Reference Number: 
TB158

Date of prequalification: 
07 March 2008
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Isoniazid/Rifampicin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 75mg/150mg
Storage condition: 
Do not store above 30° C, store in a dry condition, protect from light (HDPE Bottle, Alu/PVC/PE/PVdC blister, Alu strip ); Do not store above 25° C, store in a dry condition, protect from light (Alu/PVDC/PVC blister)
Shelf life (months): 
36 months (HDPE Bottle, Alu/PVC/PE/PVdC blister, Alu strip ), 24 months(Alu/PVDC/PVC blister )
Packaging: 
HDPE/Sachet (PET/Alu/LLDPE) 500x1; 1000x1; Blister Alu/PVC/PE/PVdC 28x3, 28x24, 10x10;Blister Alu/PVdC/PVC 28x3, 28x24, 10x10; Strip Alu/Alu 10x10
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Oxalis Labs, Vill. Theda, P.O.lodhimajra, Baddi, Distt. Solan, India
Macleods Pharmaceuticals Ltd, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 210, India

API Manufacturing Site: 

(Isoniazid) Second Pharma Co Ltd, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, 312 369, China (People's Republic of)
(Isoniazid) Amsal Chem Pvt Ltd, A-1/401-402-403 GIDC Area, Ankleshwar, Bharuch District, Gujarat, 393 002, India
(Isoniazid) Calyx Chemicals & Pharmaceuticals Ltd, Plot No-102/91/90, MIDC Industrial Area, Tarapur, Boisar, Maharashtra, 401 506, India
(Rifampicin) Novartis India Ltd, Sandoz Business Unit, Plot No L-1, Additional Phase, MIDC, Mahad, District - Raigad, Maharashtra, 402 301, India
(Rifampicin) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, Maharashtra, 401 506, India
(Rifampicin) Shenyang Antibiotic Manufacturer, Jianshebei 3 Road, Hushitai Town, Xinchengzi District, Shenyang, Liaoning, 110 122, China (People's Republic of)