Product Details
WHO Product ID
MA026
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet 20mg/120mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Novartis Pharma AG
Lichtstrasse 35
Basel,
4002
Switzerland
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PE/PVdC
Configuration
Public market (18x30, 24x30), Private market Africa (6x3, 6x4), Private market Switzerland (6x4)
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
KPC Pharmaceuticals Inc
Small Volume Injection Plant, Qigongli (W)
Kunming,
Yunnan
650 100
China
Artemether
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Lumefantrine
Zhejiang Lyee Biotechnology Co Ltd
No. 69 Luoxin Road, The North Division, Economic Development Zone
Shengzhou,
Zhejiang
312 400
China
Lumefantrine
Zhejiang Medicine Co Ltd
98 East Dadao Road
Xinchang,
Zhejiang
312 500
China
Artemether, Lumefantrine
FPP Manufacturing Site(s)
Anderson Brecon Inc
4545 Assembly Drive
Rockford,
61109
United States of America
Novartis Pharma AG
No 31 Yongan Road, Nanguan Chengguan Township, Changping District
Beijing,
Beijing
102 200
China
Novartis Pharmaceuticals Corporation
25 Old Mill Road, Suffern
Ramapo,
NY10901
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
Türkiye
Packaging Coordinators Inc
3001 Red Lion Drive
Philadelphia,
PA 19114
United States of America
Sharp Corporation
23 Carland Road
Conshohocken,
19428
United States of America