Medicines/finished pharmaceutical products

Reference Number: 
TB070

Date of prequalification: 
13 November 2003
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: 
Alu/Alu blister: Do not store above 30°C; Alu/PVC/PVdC blister and HDPE container: Do not store above 25°C. Protect from light
Shelf life (months): 
36
Packaging: 
Blister Alu/PVC/PVdC: 6x15, 28x24; Blister Alu/Alu: 6x15, 14x24; Bottle HDPE: 1000x1
Applicant: 
Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India
FPP Manufacturing Site: 

Lupin Ltd, EPIP, SIDCO Industrial Complex, Kartholi, Bari Brahmana, Jammu & Kashmir, 181 133, India
Lupin Ltd, Rifa & Non-Rifa Facilities, Block No 1 & 2, A-28/1 MIDC Industrial Area, Chikalthana, Aurangabad, 431 210, India

API Manufacturing Site: 

(Isoniazid) Amsal Chem Pvt Ltd, A-1/401-402-403 GIDC Area, Ankleshwar, Bharuch District, Gujarat, 393 002, India
(Rifampicin) Sandoz Pvt Ltd, Plot L-, Additional Phase MIDC, Mahad, Raigad District, Maharashtra, 402 301, 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
(Rifampicin) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, 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) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, Maharashtra, 401 506, India
(Isoniazid) Second Pharma Co Ltd, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, 312 369, China (People's Republic of)