WHO Product ID
TB133
Status
Prequalified
INN, dosage form and strength
Ethionamide Tablet, Film-coated 250mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Strip, Alu/Alu
Configuration
10x10, 9x10
Shelf life (months)
48
Storage conditions
Do not store above 30°C, protect from light
Packaging Type
Bottle, HDPE with Alu/PET/LDPE triple pouch
Configuration
100x1
Shelf life (months)
48
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India
Ethionamide
Pen Tsao Chemical & Pharmaceutical Industry Ltd
No 2 Teili Road, Wusong, Baoshan District
Yanghang Town,
Shanghai
200 940
China
Ethionamide
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Unit 2, Phase II, III and IV, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India
Oxalis Labs
Vill. Theda, Baddi, Distt. Solan
P.O.lodhimajra,
174101
India
