Medicines/finished pharmaceutical products

Reference Number: 
MA078

Date of prequalification: 
12 September 2012
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artesunate/Mefloquine (hydrochloride)
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 25mg/50mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister Alu/Alu: 3x1; 3x2
Applicant: 
Drugs for Neglected Diseases Initiative (DNDi), 15 Chemin Louis Dunant, Geneva, 1202, Switzerland
FPP Manufacturing Site: 

Cipla, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India

API Manufacturing Site: 

(Artesunate) Cipla Ltd, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
(Mefloquine (hydrochloride)) Sifavitor Srl, Largo Donegani Guido, 2, Milan, 20121, Italy
(Artesunate) Cipla Ltd, Unit 1, Plot A-33 & A-2 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India