Medicines/finished pharmaceutical products

Reference Number: 
TB179

Date of prequalification: 
23 April 2008
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Isoniazid
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet 300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
48
Packaging: 
Blister Al/PVC/PVdC: 10x3, 10x10, 10x9, 28x3, 28x24, 7x6; 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: 

Macleods Pharmaceuticals Ltd, Block No. N2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi, District Solan, Himachal Pradesh, 174 101, India
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) Second Pharma Co Ltd, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, 312 369, China (People's Republic of)
(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