药品/药物成品

Reference Number: 
MA128

Date of prequalification: 
21 April 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 40mg/240mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Blister,Alu/PVC-PVdC 6x1; 6x30
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: 

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