Medicines/finished pharmaceutical products

Reference Number: 
TB333

Date of prequalification: 
30 May 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethionamide
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Dispersible 125mg
Storage condition: 
Do not store above 30°C, store in dry condition, protect from light
Shelf life (months): 
36
Packaging: 
Strip,Alu/Alu 6x5; 10x10
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

API Manufacturing Site: 

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