Medicines/finished pharmaceutical products

Reference Number: 
MA094 (a)

Date of prequalification: 
09 October 2015
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Dihydroartemisinin/Piperaquine (phosphate)
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet, Film-coated 40mg/320mg
Storage condition: 
SRA accepted: Do not store above 30°C. Store in the original package in order to protect from light and moisture; WHO recommended: Do not store above 30°C. Store in the original package in order to protect from light and moisture. Avoid excursions over 30°C
Shelf life (months): 
24
Packaging: 
Blister,Alu/PVC/PVdC 3x1,6x1,9x1,12x1
Applicant: 
Alfasigma S.p.A, Via Pontina Km 30.400, 00071, Pomezia, Rome, Italy
FPP Manufacturing Site: 

Alfasigma S.p.A, Via Pontina Km 30.400, 00071, Pomezia, Rome, Italy

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Piperaquine (phosphate)) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Dihydroartemisinin) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India