Product Details
WHO Product ID
MA190
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
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
Packaging details and storage conditions
Packaging Type
Blister; Alu/PVC
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
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
457 002
India
Amodiaquine (hydrochloride)
Mangalam Drugs and Organics Limited
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Sulfadoxine
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Pyrimethamine, Sulfadoxine
FPP Manufacturing Site(s)
Ipca Laboratories Ltd
Plot No 255/1, Village Athal
Silvassa,
Dadra and Nagar Haveli
Daman and Diu 396230
India