Medicines/finished pharmaceutical products

Reference Number: 
MA132

Date of prequalification: 
31 October 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Amodiaquine (hydrochloride)/Artesunate
Therapeutic area: 
Malaria
Dosage form & strength: 
Tablet 67.5mg/25mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister,Alu/Alu 3x1, 3x10, 3x25; Blister, Alu-PVC/Aclar 3x1, 3x10, 3x25
Applicant: 
Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa, 403 722, India

API Manufacturing Site: 

(Artesunate) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India
(Amodiaquine (hydrochloride)) Ipca Laboratories Ltd, Sejavta, Ratlam, Madhya Pradesh, 457 002, India