Medicines/finished pharmaceutical products

Reference Number: 
HA595

Date of prequalification: 
27 August 2015
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ondansetron (hydrochloride)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 4mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Blister;Alu/Alu 10x1, 10x2, 10x3, 10x5, 10x6, 10x9, 10x10, 10x30, 30x1, 30x2, 30x3, 30x10
Applicant: 
Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India
FPP Manufacturing Site: 

Cadila Pharmaceuticals Ltd, 1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 387 810, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Ondansetron (hydrochloride)) Cadila Pharmaceuticals Ltd, 294 GIDC Industrial Estate, Ankleshwar, 393 002, India

API WHO Public Inspection Reports: