Medicines/finished pharmaceutical products

Reference Number: 
MA110

Date of prequalification: 
12 December 2017
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: 
Alu/PVC/PVdC 6x1, 12x1
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) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Artemether) Solara Active Pharma Sciences Ltd, 120 A & B, 36, 120P & 121 Industrial Area, Baikampady, New Mangalore, Karnataka, 575 011, India
(Lumefantrine) Solara Active Pharma Sciences Ltd, 120 A & B, 36, 120P & 121 Industrial Area, Baikampady, New Mangalore, Karnataka, 575 011, India