Product Details
WHO Product ID
MA170
Status
Prequalified
INN, dosage form and strength
Pyrimethamine/Sulfadoxine Tablet, Dispersible+Amodiaquine (hydrochloride) Tablet, Dispersible 12.50mg/250mg+76.5mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible + Tablet, Dispersible
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
50x([3 Amodiaquine dispersible tablets] + [1 Sulfadoxine/Pyrimethamine dispersible tablets])
Shelf life (months)
48
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
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India
Pyrimethamine, Sulfadoxine
Mangalam Drugs & Organics Ltd
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)
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India