Medicines/finished pharmaceutical products

Reference Number: 
MA108

Date of prequalification: 
15 July 2015
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 80mg/480mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister;PVC/PE/PVdC 6x1
Applicant: 
Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland
FPP Manufacturing Site: 

Novartis Saglik, Gida ve Tarim Urunleri San. Ve Tic. A.S., Yenişehir Mahallesi Ihlara Vadisi Sokak No. 2, Pendik, Istanbul, TR 34912, Turkey
Packaging Coordinators Inc, 3001 Red Lion Drive, Philadelphia, Pennsylvania, PA 19114, United States of America
Anderson Brecon Inc, 4545 Assembly Drive, Rockford, Illinois, 61109, United States of America

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Artemether) Zhejiang Medicine Co Ltd, 98 East Dadao Road, Xinchang, Zhejiang, 312 500, China (People's Republic of)
(Artemether) KPC Pharmaceuticals Inc, Small Volume Injection Plant, Qigongli (W), Kunming, Yunnan, 650 100, China (People's Republic of)
(Lumefantrine) Zhejiang Medicine Co Ltd, 98 East Dadao Road, Xinchang, Zhejiang, 312 500, China (People's Republic of)

API WHO Public Inspection Reports: