WHO Product ID
MA172
Status
Prequalified
INN, dosage form and strength
Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 75mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible + Tablet, Dispersible
Applicant organization
Universal Corporation Ltd
PO Box 1748, Club Road, Plot No 13777
Kikuyu,
902
Kenya
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVDC/PVC
Configuration
(1+3) x 25; (1+3) x 30; (1+3) x 50
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Avoid excursions above 30°C. Protect from light and moi
API Manufacturing Site(s)
By Organization
By Active Ingredient
Anuh Pharma Ltd
E17/3 & 17/4 & E-18 MIDC, Boisar Tarapur Taluka-Palghar, Thane District
Maharashtra
401 506
India
Sulfadoxine
Mangalam Drugs and Organics Limited
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Amodiaquine (hydrochloride), Sulfadoxine
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Amodiaquine (hydrochloride), Pyrimethamine, Sulfadoxine
FPP Manufacturing Site(s)
Universal Corporation Ltd
PO Box 1748, Club Road, Plot No 13777
Kikuyu,
902
Kenya