UB441
ProductIopamidol Injection
Strength200mg(I)/ml (41%): 10ml, 20ml, 50ml 250mg(I)/ml (51%): 50ml 300mg(I)/ml (61%): 15ml, 30ml, 50ml 370mg(I)/ml (76%): 50ml, 75ml, 100ml
IndicationsAngiography; Computerised tomography; Urography; Radiography
TherapeuticsMedical Devices & Diagnostics
GMPUS - FDA
RegistrationUnited States
ModalitiesSmall Molecule
Exclusive Summary
- - Nonionic low-osmolar iodinated contrast covering 200–370 mgI/ml and 10–100 ml pack sizes fits CT/CTA/interventional use broadly.
- - Originator patents expired; generics present in many markets with steady, growing demand enabling rapid distribution.
- - US registration and compliant manufacturing de-risk CTD filings and local market audits for import and access.
- - Guidelines (ACR/ESUR) position nonionic low-osmolar agents as standard, first-line for contrast-enhanced CT and angiography.
- - Offers 20–40% price savings vs originators, with deeper cuts in tenders, improving hospital cost efficiency.
How can we help you?
Receive insights into the latest events and regulatory updates
Sent directly to your email
Get industry insights and Unibest news here
Contact Us →