Medicines/finished pharmaceutical products

Reference Number: 
MA092

Date of prequalification: 
19 December 2012
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet, Dispersible 20mg/120mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Blister Alu/PVdC/PVC: 6x1, 12x1; 6x30, 12x30
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
Ajanta Pharma Limited, Z/103/A, Dahej SEZ-II, Bharuch, Gujarat, 392130, India

API Manufacturing Site: 

(Lumefantrine) Mangalam Drugs and Organics Limited, Unit-2, G.I.D.C, 3rd Phase, Plot no. 1203, Vapi, Valsad, Gujarat, 396 195, India
(Artemether) Mangalam Drugs and Organics Limited, Unit-2, G.I.D.C, 3rd Phase, Plot no. 1203, Vapi, Valsad, 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
(Artemether) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India
(Lumefantrine) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Artemether) Calyx Chemicals & Pharmaceuticals Ltd, Plot No-102/91/90, MIDC Industrial Area, Tarapur, Boisar, Maharashtra, 401 506, India
(Lumefantrine) Calyx Chemicals & Pharmaceuticals Ltd, Plot No-102/91/90, MIDC Industrial Area, Tarapur, Boisar, Maharashtra, 401 506, India
(Lumefantrine) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India