Medicines/finished pharmaceutical products

Reference Number: 
TB174

Date of prequalification: 
01 November 2010
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, store in dry condition, protect from light
Shelf life (months): 
60 (bottle pack); 36 (blister pack)
Packaging: 
Bottle HDPE: 1000x1; Alu/PVC/EVOH/Aclar blister: 28x24; 10 x 10
Applicant: 
Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Unit 03, 92 Sipcot Industrial Complex, Hosur, Tamil Nadu, 635 126, India

API Manufacturing Site: 

(Isoniazid) Amsal Chem Pvt Ltd, A-1/401-402-403 GIDC Area, Ankleshwar, Bharuch District, Gujarat, 393 002, India
(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