Medicines/finished pharmaceutical products

Reference Number: 
MA081

Date of prequalification: 
01 June 2012
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
Shelf life (months): 
24
Packaging: 
Blister Alu/Alu: 3x10, 3x25
Applicant: 
Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India
FPP Manufacturing Site: 

Ipca Laboratories Ltd, Plot No 255/1, Village Athal, Silvassa, Dadra & Nagar Haveli (Union Territory), 396 230, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Artesunate) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Artesunate) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India
(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