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)
36
Storage conditions
Do not store above 30°C. Store tablets in blisters in the provided carton in order to protect from light
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
Palghar,
Maharashtra
401 506
India
Pyrimethamine, Sulfadoxine
Ipca Laboratories Ltd
89A-B, 90/91 Industrial Estate, Pologround
Indore,
Madhya Pradesh
452 003
India
Amodiaquine (hydrochloride)
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 001
India
Amodiaquine (hydrochloride)
Mangalam Drugs and Organics Limited
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Amodiaquine (hydrochloride)
FPP Manufacturing Site(s)
S Kant Healthcare Ltd.
Plot No. 1802-1805, G.I.D.C, Phase III
Vapi,
Gujarat
396195
India
