Medicines/finished pharmaceutical products

Reference Number: 
MA138

Date of prequalification: 
06 February 2019
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. Store tablets in the blisters in the provided carton
Shelf life (months): 
24
Packaging: 
Blister, Alu-PVC/PE/PVdC 6x1
Applicant: 
Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore
FPP Manufacturing Site: 

Strides Pharma Science Limited, Oral Solid Dosage Forms Division, KRS Gardens, 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk, Bangalore, Karnataka, 562 106, India

API Manufacturing Site: 

(Artemether) Solara Active Pharma Sciences Ltd, 120 A & B, 36, 120P & 121 Industrial Area, Baikampady, New Mangalore, Karnataka, 575 011, India
(Lumefantrine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)