Medicines/finished pharmaceutical products

Reference Number: 
TB346 (a)

Date of prequalification: 
14 March 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Terizidone
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Capsules, hard 250mg
Storage condition: 
Do not store above 25°C. Avoid excursions above 30°C
Shelf life (months): 
36
Packaging: 
Blister, Alu/PVC 10x5
Applicant: 
RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald, Germany
FPP Manufacturing Site: 

SW Pharma GmbH, Robert-Koch-Straße 1, 66578 Schiffweiler, Germany
L-A-W Services GmbH – Leipziger Arzneimittelwerk, Elisabeth-Schumacher-Straße 54/56, 04328 Leipzig, Germany
Prestige Promotion Verkaufsförderung & Werbeservice GmbH, Lindigstraße 6, 63801 Kleinostheim, Germany (Additional secondary packaging)

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Terizidone) ST Pharm Co. Ltd, Banwol Site 2, 171, Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15610, Republic of Korea
(Terizidone) ST Pharm Co Ltd, Sihwa Site, 231, Hyeomnyeok-ro, Siheung-si, Gyeonggi-do, Republic of Korea

API WHO Public Inspection Reports: