Medicines/finished pharmaceutical products

Reference Number: 
MA111

Date of prequalification: 
06 October 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 20mg/120mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Blister Alu/PVdC/PVC: 6x1,12x1, 18x1, 24x1, 6x30,12x30, 18x30, 24x30
Applicant: 
Ajanta Pharma Ltd, Ajanta House, Charkop, Kandivli (W), Mumbai, 400 067, India
FPP Manufacturing Site: 

Ajanta Pharma Limited, Z/103/A, Dahej SEZ-II, Bharuch, Gujarat, 392130, India
Ajanta Pharma Ltd, B4/5/6 MIDC Industrial Area, Aurangabad, Paithan District, Maharashtra, 431 148, India

API Manufacturing Site: 

(Artemether) Calyx Chemicals & Pharmaceuticals Ltd, Plot No-102/91/90, MIDC Industrial Area, Tarapur, Boisar, Maharashtra, 401 506, India
(Artemether) Mangalam Drugs and Organics Limited, Unit-2, G.I.D.C, 3rd Phase, Plot no. 1203, Vapi, Valsad, Gujarat, 396 195, India
(Lumefantrine) Mangalam Drugs and Organics Limited, Unit-2, G.I.D.C, 3rd Phase, Plot no. 1203, Vapi, Valsad, Gujarat, 396 195, India
(Lumefantrine) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Artemether) Solara Active Pharma Sciences Ltd, 120 A & B, 36, 120P & 121 Industrial Area, Baikampady, New Mangalore, Karnataka, 575 011, India
(Artemether) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Lumefantrine) Solara Active Pharma Sciences Ltd, 120 A & B, 36, 120P & 121 Industrial Area, Baikampady, New Mangalore, Karnataka, 575 011, India
(Lumefantrine) Calyx Chemicals & Pharmaceuticals Ltd, Plot No-102/91/90, MIDC Industrial Area, Tarapur, Boisar, Maharashtra, 401 506, India