Product Details
WHO Product ID
MA132
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
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/Aclar
Configuration
3x1, 3x10, 3x25
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/Alu
Configuration
3x1, 3x10, 3x25
Shelf life (months)
24
Storage conditions
Do not store above 30°C
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), Artesunate
FPP Manufacturing Site(s)
Micro Labs Limited
Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate
Verna,
Goa
403 722
India