Product Details
WHO Product ID
MA064
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet 20mg/120mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
6x1, 6x2, 6x3, 6x4
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light
Packaging Type
Blister, Alu/PVC/PCTFE
Configuration
6x1, 12x1, 18x1, 24x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cipla Ltd
Plot D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Lumefantrine
Cipla Ltd
Plot D-7 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Lumefantrine
Cipla Ltd
Unit 2, Plot A-42 MIDC Industrial Area, Raigad District
Patalganga,
Maharashtra
410 220
India
Artemether, Lumefantrine
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Artemether, Lumefantrine
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201 302
China
Artemether, Lumefantrine
FPP Manufacturing Site(s)
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
Unit 1, PO Bhud, Upper Malpur Village, Solan District
Tehsil, Nalagarh,
Himachal Pradesh
173 205
India
Cipla Ltd
Unit IV, Plot No 9, 10 & 15 Indore Special Economic Zone, Phase II, Dhar District
Pithampur,
Madhya Pradesh
454 775
India
Cipla Ltd.
Plot D-7 (Unit1), MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Cipla Quality Chemical Industries Ltd
PO Box 34871, Plot No 1-7 Ring Road, Luzira Industrial Park
Kampala,
Uganda
Cipla
Unit 2, Plot A-42 MIDC, Patalganga, Raigad District
Maharashtra
410 220
India