Gadobenate Dimeglumine

In response to the diagnostic imaging needs of the central nervous system and thoracoabdominal organs, gadobenate dimeglumine, as a second-generation biphasic gadolinium-based contrast agent, addresses the application limitations of conventional extracellular contrast agents with its unique mechanism of action. Its mechanism of action involves shortening the T1 relaxation time of tissues via gadolinium ions to enhance imaging contrast, while it also possesses the property of specific uptake by hepatocytes. It is suitable for magnetic resonance imaging (MRI) examination of brain and spinal cord lesions, and can clearly identify central nervous system tumors and areas with damaged blood-brain barrier. It can also be used to differentiate benign and malignant lesions of abdominal organs such as the liver and biliary tract, and clinically covers the diagnostic imaging needs of multiple departments including neurology, neurosurgery, oncology, and gastroenterology, making it an important adjuvant drug for current clinical precise diagnosis.

The current global market size of gadolinium-based contrast agents has exceeded US$1.8 billion, with a compound annual growth rate maintained at approximately 4.2%. Among them, the market share of biphasic gadolinium-based contrast agents is increasing at a rate of 1.8 percentage points per year, mainly driven by the rising penetration rate of MRI equipment in medical institutions at all levels and the continuously improving clinical requirements for the accuracy of differential diagnosis of benign and malignant lesions. In the domestic market, the market share of gadobenate dimeglumine is still dominated by foreign-funded original research products at present, accounting for more than 70%. With the advancement of the consistency evaluation of generic drugs, generic preparations from 3 domestic enterprises have been approved for marketing. After centralized procurement, the terminal price has dropped by more than 60%, the penetration rate in the downstream market is increasing rapidly, and the corresponding demand for active pharmaceutical ingredients (APIs) and impurity reference standards has also grown accordingly.

The original research enterprise of gadobenate dimeglumine is Bracco Imaging S.p.A (Italian Bracco Imaging Company), and the original research trade name is MultiHance. Its core compound patent has expired in China, and the main patents in the EU and US markets expired in 2014 and 2016 respectively. The main dosage form of the original research product launched is injection, with specifications of 10ml:5.290g, 15ml:7.935g and 20ml:10.580g. It has been included in the Chinese *Catalogue of Chemical Reference Preparations* and also listed in the FDA Reference Preparation Catalogue. At present, 6 domestic enterprises have completed the registration of gadobenate dimeglumine APIs at the CDE and obtained Class A status, and another 8 enterprises have obtained marketing approval for gadobenate dimeglumine injection. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for gadobenate dimeglumine APIs. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for the whole process of API R&D, consistency evaluation, quality control, etc.