Medicines/finished pharmaceutical products

Reference Number: 
MA058

Date of prequalification: 
14 October 2008
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Amodiaquine (hydrochloride)/Artesunate
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 270mg/100mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister Alu/Alu: 3x1, 3x25, 6x1, 6x25
Applicant: 
Sanofi, 82, avenue Raspail, 94250 - Gentilly, France
FPP Manufacturing Site: 

Maphar Laboratories, Zenata Site, Km 10 route Côtière 111, QI Zenata, Aïn Sebaâ, Casablanca, Morocco
Sanofi-Aventis Maroc, Route de Rabat RP 1 – Aïn Sebaâ, 20250, Casablanca, Morocco
Rottendorf Pharma GmbH, Ostenfelder Strasse 51-61, Ennigerloh, North Rhine-Westphalia, 59320, Germany

API Manufacturing Site: 

(Artesunate) Sanofi SpA, Via R. Lepetit 142, Garessio, 12075, Italy
(Amodiaquine (hydrochloride)) Ipca Laboratories Ltd, 89A-B, 90/91 Industrial Estate, Pologround, Indore, Madhya Pradesh, India
(Amodiaquine (hydrochloride)) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India
(Amodiaquine (hydrochloride)) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India