Medicines/finished pharmaceutical products

Reference Number: 
MA121

Date of prequalification: 
17 July 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Artemether/Lumefantrine
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 60mg/360mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister, Alu/PVC/ACLAR/PVC 6x1
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, PO Bhud, Upper Malpur Village, Tehsil, Nalagarh, Solan District, Himanchal Pradesh, 173 205, India

FPP WHO Public Inspection Reports: 
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)