Medicines/finished pharmaceutical products

Reference Number: 
MA095

Date of prequalification: 
10 July 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Amodiaquine (hydrochloride)/Artesunate
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 67.5mg/25mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister Alu/OPA/Alu/PVC: 3x1; 3x25
Applicant: 
Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India
FPP Manufacturing Site: 

Ajanta Pharma Ltd, B4/5/6 MIDC Industrial Area, Aurangabad, Paithan District, Maharashtra, 431 148, India

API Manufacturing Site: 

(Artesunate) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Artesunate) Solara Active Pharma Sciences Ltd, 120 A & B, 36, 120P & 121 Industrial Area, Baikampady, New Mangalore, Karnataka, 575 011, India
(Amodiaquine (hydrochloride)) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India