Medicines/finished pharmaceutical products

Reference Number: 
TB302

Date of prequalification: 
31 August 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Isoniazid/Rifampicin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Dispersible 50mg/75mg
Storage condition: 
Do not store above 25°C, protect from light
Shelf life (months): 
24
Packaging: 
LDPE bag in Triple Laminate sachet in HDPE container 100x1; Strip, Alu/Alu 10x10; 28x3
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) Calyx Chemicals & Pharmaceuticals Ltd, Plot No-102/91/90, MIDC Industrial Area, Tarapur, Boisar, 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)
(Rifampicin) Sandoz Pvt Ltd, Plot L-, Additional Phase MIDC, Mahad, Raigad District, Maharashtra, 402 301, India