Medicines/finished pharmaceutical products

Reference Number: 
TB133

Date of prequalification: 
21 December 2007
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethionamide
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 250mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
48
Packaging: 
Strip Alu/Alu:10x10; Bottle HDPE:100x1
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: 

(Ethionamide) Macleods Pharmaceuticals Ltd, Plot No 2209 GIDC Industrial Area, At and Post Sarigam, Taluka: Umbergeon, Valsad District, Gujarat, 396 155, India
(Ethionamide) Pen Tsao Chemical & Pharmaceutical Industry Ltd, No 2 Teili Road, Wusong, Shangnai, 200 940, China (People's Republic of)