WHO Product ID
MA198
Status
Prequalified
INN, dosage form and strength
Pyrimethamine/Sulfadoxine Tablet, Dispersible+Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg+153mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible + Tablet, Dispersible
Applicant organization
Ajanta Pharma Ltd
Ajanta House, Charkop, Kandivli (W)
Mumbai,
Maharashtra
400 067
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC
Configuration
(3 Amodiaquine Tablets + 1Sulfadoxine/Pyrimethamine Tablet) x 50
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Avoid excursions above 30°C. Protect from light and moisture
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)
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Amodiaquine (hydrochloride), Pyrimethamine
FPP Manufacturing Site(s)
Ajanta Pharma Ltd
B4/5/6 MIDC Industrial Area, Paithan District
Chhatrapati Sambhajinagar,
Maharashtra
431 148
India