Medicines/finished pharmaceutical products

Reference Number: 
TB168

Date of prequalification: 
07 March 2008
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 275mg/75mg/400mg/150mg
Storage condition: 
Do not store above 30° C, store in a dry condition, protect from light (Alu strip ); Do not store above 25° C, store in a dry condition, protect from light (HDPE Bottle, Alu/PVC/PE/PVdC blister, Alu/PVDC/PVC blister)
Shelf life (months): 
24 (HDPE Bottle, Alu/PVC/PVdC blister), 36 (Alu/PVC/PE/PVdC blister, Alu strip )
Packaging: 
Bottle HDPE: 500x1, 1000x1; Blister Alu/PVC/PE/PVdC: 10x10,28x3, 28x24; Blister Alu/PVC/PVdC: 10x10,28x3, 28x24;Strip Al/Al: 10x10, 28x3, 28x24
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)
(Rifampicin) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, 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) Shenyang Antibiotic Manufacturer, Jianshebei 3 Road, Hushitai Town, Xinchengzi District, Shenyang, Liaoning, 110 122, 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
(Pyrazinamide) Calyx Chemicals & Pharmaceuticals Ltd, Plot No-102/91/90, MIDC Industrial Area, Tarapur, Boisar, Maharashtra, 401 506, India
(Ethambutol hydrochloride) Lupin Ltd, Plot No. 09, 123, 123/1, 124 & 125 -Ethambutol (ETB) Plant, GIDC Estate, Ankleshwar 393 002, Gujarat, India
(Pyrazinamide) Anuh Pharma Ltd, E17/3 & 17/4 MIDC, Boisar, Tarapur, Thane District, Maharashtra, 401 506, India
(Pyrazinamide) Macleods Pharmaceuticals Ltd, Plot No 2209 GIDC Industrial Area, At and Post Sarigam, Taluka: Umbergaon, Valsad District, Gujarat, 396 155, India