Medicines/finished pharmaceutical products

Reference Number: 
MA115

Date of prequalification: 
17 July 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet, Dispersible 20mg/120mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister Alu/PVC/Aclar/PVC 6x1;12x1;18x1;6x30;12x30;18x30
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit IV, Plot No 9, 10 & 15 Indore Special Economic Zone, Phase II, Pithampur, Dhar District, Madhya Pradesh, 454 775, India

API Manufacturing Site: 

(Artemether) 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)