Product Details
WHO Product ID
MA147
Status
Prequalified
INN, dosage form and strength
Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 150mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible + Tablet, Dispersible
Applicant organization
S Kant Healthcare Ltd
3-A, Shiv Sagar Estate, North Wing, Dr. Annie Besant Road, Worli
Mumbai,
400 018
India
Packaging details and storage conditions
Packaging Type
Co-blister, Alu-PVC/PVDC
Configuration
(1+3) x 25; (1+3) x 50
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store tablets in blisters in the provided carton in ord
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
Pyrimethamine, Sulfadoxine
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Amodiaquine (hydrochloride)
FPP Manufacturing Site(s)
S Kant Healthcare Limited
Plot No. 1802-1805, G.I.D.C, Phase III
Vapi,
Gujarat
396195
India