Medicines/finished pharmaceutical products

Reference Number: 
TB178

Date of prequalification: 
23 April 2008
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Isoniazid
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet 100mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC/PVdC: 10x3, 28x3, 28x24,10x10; Bottle, HDPE: 1000x1 in LDPE bag
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Oxalis Labs, Vill. Theda, P.O.lodhimajra, Baddi, Distt. Solan, India
Macleods Pharmaceuticals Ltd, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 210, 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
(Isoniazid) Second Pharma Co Ltd, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, 312 369, China (People's Republic of)