Medicines/finished pharmaceutical products

Reference Number: 
MA026 (a)

Date of prequalification: 
26 April 2004
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 20mg/120mg
Storage condition: 
Do not store above 30°C, protect from moisture
Shelf life (months): 
24
Packaging: 
Blister Alu/PVC/PE/PVdC: Public market (18x30, 24x30), Private market Africa (6x3, 6x4), Private market Switzerland (6x4)
Applicant: 
Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland
FPP Manufacturing Site: 

Novartis Saglik, Gida ve Tarim Urunleri San. Ve Tic. A.S. Yenisehir, Cad No. 17 (11.SOK No. 2), Kurtköy, Istanbul, TR 34912, Turkey
Novartis Pharma AG, No 31 Yongan Road, Nanguan Chengguan Township, Beijing, Changping District, 102 200, China (People's Republic of)
Novartis Pharmaceuticals Corporation, 25 Old Mill Road, Suffern, Ramapo, Rockland County, NY10901, United States of America
Sharp Corporation , 23 Carland Road, Conshohocken, Pennsylvania, 19428, United States of America
Catalent Pharma Solutions LLC, 3001 Red Lion Road, Philadelphia, Philadelphia, 19114, United States of America

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 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)

API WHO Public Inspection Reports: