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MA099

Product Details
WHO Product ID
MA099
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
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/Aclar
Configuration
6x1, 6x2, 6x3, 6x4; 18x1; 24x1; 18x10;24x10;18x30; 24x30
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/Alu (desiccant embedded)
Configuration
6x1, 6x2, 6x3, 6x4; 18x1; 24x1; 18x10;24x10; 18x30; 24x30
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/PVC/PE/PVdC
Configuration
6x1, 6x2, 6x3, 6x4; 18x1; 24x1; 18x10;24x10;18x30; 24x30
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/Alu
Configuration
6x1, 6x2, 6x3, 6x4; 18x1; 24x1; 18x10;24x10;18x30; 24x30
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Artemether, Lumefantrine
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Artemether, Lumefantrine
Mylan Laboratories Ltd
Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India
Lumefantrine
Mylan Laboratories Ltd
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India
Artemether
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, District Dhar
Pithampur,
Madhya Pradesh
454 775
India
Mylan Laboratories Ltd
F4 & F12 Malegaon MIDC, Nashik District
Sinnar,
Maharashtra
422 113
India
FPP Packaging Only
Mylan Laboratories Limited
Plot No. P 1/6 of 10723, Lusaka South Multi-Facility Economic Zone, Chifwena Road
Lusaka,
Lusaka
Zambia
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 6 , Part 6a , Part 7 , Part 8

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