Product Details
WHO Product ID
MA056
Status
Prequalified
INN, dosage form and strength
Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Sanofi
82, avenue Raspail
Gentilly,
94250
France
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
3x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Huvepharma Italia S.r.l
Via R. Lepetit 142
Garessio,
12075
Italy
Artesunate
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
Amodiaquine (hydrochloride)
FPP Manufacturing Site(s)
Maphar Laboratories
Boulevard ALKIMIA N°6, Quartier industriel Sidi Bernoussi
Casablanca,
20250
Morocco
Sanofi-Aventis Maroc
Route de Rabat RP 1 – Aïn Sebaâ, 20250
Casablanca,
Morocco