Medicines/finished pharmaceutical products

Reference Number: 
MA069 (a)

Date of prequalification: 
27 February 2009
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet, Dispersible 20mg/120mg
Storage condition: 
Do not store above 30°C, protect from moisture, protect from light
Shelf life (months): 
24
Packaging: 
Blister Alu/PVC/PCTFE : 6x1, 6x2, 6x30, 12x30
Applicant: 
Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland
FPP Manufacturing Site: 

Anderson Brecon Inc, 4545 Assembly Drive, Rockford, Illinois, 61109, United States of America
Sharp Corporation , 23 Carland Road, Conshohocken, Pennsylvania, 19428, United States of America
Novartis Saglik, Gida ve Tarim Urunleri San. Ve Tic. A.S., Yenişehir Mahallesi Ihlara Vadisi Sokak No. 2, Pendik, Istanbul, TR 34912, Turkey
Catalent Pharma Solutions LLC, 3001 Red Lion Road, Philadelphia, Philadelphia, 19114, United States of America
Novartis Pharma AG, No 31 Yongan Road, Nanguan Chengguan Township, Beijing, Changping District, 102 200, China (People's Republic of)

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Artemether) KPC Pharmaceuticals Inc, Small Volume Injection Plant, Qigongli (W), Kunming, Yunnan, 650 100, China (People's Republic of)
(Artemether) Zhejiang Medicine Co Ltd, 98 East Dadao Road, Xinchang, Zhejiang, 312 500, China (People's Republic of)
(Lumefantrine) Zhejiang Health Creation Biotechnology Co Ltd, Chengbei Industrial Zone, Shengzhou, Zhejiang, 312 400, 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: