Medicines/finished pharmaceutical products

Reference Number: 
MA064

Date of prequalification: 
22 May 2009
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): 
Alu/Alu blister (24 months) Alu/PVC/PCTFE (36 months)
Packaging: 
Blister Alu/Alu: 6x1, 6x2, 6x3, 6x4; Blister Alu/PVC/PCTFE: 6x1, 12x1, 18x1, 24x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit 1, Plot A-33, A-37 & A-2 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
Cipla, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
Cipla Ltd, Unit 3, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette, Goa, 403 722, India
Cipla Ltd, Unit 4, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette, Goa, 403 722, India
Cipla Ltd, Unit 7, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette, Goa, 403 722, India
Cipla Ltd., Plot D-7 (Unit1), MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
Cipla Ltd, Unit 1, PO Bhud, Upper Malpur Village, Tehsil, Nalagarh, Solan District, Himanchal Pradesh, 173 205, India
Cipla Ltd, Unit IV, Plot No 9, 10 & 15 Indore Special Economic Zone, Phase II, Pithampur, Dhar District, Madhya Pradesh, 454 775, India
Cipla Quality Chemical Industries Ltd, PO Box 34871, Plot No 1-7 Ring Road, Luzira Industrial Park, Kampala, Uganda

API Manufacturing Site: 

(Artemether) Cipla Ltd, Unit 1, Plot A-33 & A-2 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
(Artemether) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Artemether) Cipla Ltd, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
(Artemether) 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
(Lumefantrine) Cipla Ltd, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
(Lumefantrine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Lumefantrine) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India