Medicines/finished pharmaceutical products

Reference Number: 
MA126

Date of prequalification: 
15 May 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Amodiaquine (hydrochloride)/Artesunate
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 135mg/50mg
Storage condition: 
Do not store above 30°C, store in dry condition, protect from light
Shelf life (months): 
24
Packaging: 
Blister;Alu/Alu 10x10
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 210, India

API Manufacturing Site: 

(Artesunate) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Amodiaquine (hydrochloride)) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India