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.
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