Product Details
WHO Product ID
MA115
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
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/PVC/Aclar/PVC
Configuration
6x1;12x1;18x1;6x30;12x30;18x30
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cipla Ltd
Unit 2, Plot A-42 MIDC Industrial Area, Raigad District
Patalganga,
Maharashtra
410 220
India
Artemether
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
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201 302
China
Lumefantrine
FPP Manufacturing Site(s)
Cipla Ltd
Unit IV, Plot No 9, 10 & 15 Indore Special Economic Zone, Phase II, Dhar District
Pithampur,
Madhya Pradesh
454 775
India