Product Details
WHO Product ID
MA057
Status
Prequalified
INN, dosage form and strength
Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg
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 & Organics Ltd
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