Medicines/finished pharmaceutical products

Reference Number: 
TB195

Date of prequalification: 
29 January 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Isoniazid/Rifampicin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet 150mg/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: 
Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India
FPP Manufacturing Site: 

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
(Isoniazid) 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
(Isoniazid) Second Pharma Co Ltd, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, 312 369, China (People's Republic of)