Medicines/finished pharmaceutical products

Reference Number: 
TB192

Date of prequalification: 
19 December 2012
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethambutol hydrochloride/Isoniazid/Rifampicin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 275mg/75mg/150mg
Storage condition: 
Do not store above 25°C, protect from moisture, protect from light
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 1000x1; Blister Alu/PVC/PVdC: 28x24
Applicant: 
Svizera Europe BV, Antennestraat 43, AH Almere, 1320, Netherlands
FPP Manufacturing Site: 

Svizera Labs Pvt Ltd, Plot No D16/6 TTC Industrial Area, MIDI, Turbhe, Navi Mumbai, 400 703, India

API Manufacturing Site: 

(Isoniazid) Calyx Chemicals & Pharmaceuticals Ltd, Plot No-102/91/90, MIDC Industrial Area, Tarapur, Boisar, Maharashtra, 401 506, India
(Ethambutol hydrochloride) Lupin Ltd, Plant 1 -Ethambutol (ETB) Plant, Plot 124 GIDC Estate, Ankleshwar, Gujarat, 393 002, India
(Rifampicin) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, Maharashtra, 401 506, India
(Rifampicin) Sandoz Pvt Ltd, Plot L-, Additional Phase MIDC, Mahad, Raigad District, Maharashtra, 402 301, India
(Isoniazid) Second Pharma Co Ltd, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, 312 369, China (People's Republic of)
(Rifampicin) Shenyang Antibiotic Manufacturer, Jianshebei 3 Road, Hushitai Town, Xinchengzi District, Shenyang, Liaoning, 110 122, China (People's Republic of)