Product Details
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 & Organics Ltd
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