Medicines/finished pharmaceutical products

Reference Number: 
TB309

Date of prequalification: 
12 December 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Isoniazid/Pyrazinamide/Rifampicin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Dispersible 50mg/150mg/75mg
Storage condition: 
Do not store above 25°C, store in dry condition, protect from light
Shelf life (months): 
24
Packaging: 
Strip Alu/Alu 10x10;28x3; HDPE Bottle 100x1
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

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

API Manufacturing Site: 

(Rifampicin) Shenyang Antibiotic Manufacturer, Jianshebei 3 Road, Hushitai Town, Xinchengzi District, Shenyang, Liaoning, 110 122, China (People's Republic of)
(Rifampicin) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, Maharashtra, 401 506, India
(Isoniazid) Amsal Chem Pvt Ltd, A-1/401-402-403 GIDC Area, Ankleshwar, Bharuch District, Gujarat, 393 002, India
(Isoniazid) Second Pharma Co Ltd, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, 312 369, China (People's Republic of)
(Pyrazinamide) Anuh Pharma Ltd, E17/3 & 17/4 MIDC, Boisar, Tarapur, Thane District, Maharashtra, 401 506, India
(Rifampicin) Sandoz Pvt Ltd, Plot L-, Additional Phase MIDC, Mahad, Raigad District, Maharashtra, 402 301, India
(Pyrazinamide) Macleods Pharmaceuticals Ltd, Plot No 2209 GIDC Industrial Area, At and Post Sarigam, Taluka: Umbergeon, Valsad District, Gujarat, 396 155, India