Beilu Pharmaceutical's Gadobenate Dimeglumine Injection Passes Generic Drug Consistency Evaluation!

Recently, Beilu Pharmaceutical received the "Drug Supplementary Application Approval Notice" (Notice Number: 2024B01144) for Gadobenate Dimeglumine Injection issued by the National Medical Products Administration. Gadobenate Dimeglumine Injection has passed the generic drug quality and efficacy consistency evaluation.

Gadobenate Dimeglumine Injection is a paramagnetic contrast agent suitable for diagnostic magnetic resonance imaging (MRI) of the liver, central nervous system, and blood vessels. According to Minedata, the sales of Gadobenate Dimeglumine Injection in Chinese public medical institutions have been increasing year by year, exceeding 160 million yuan in 2022, and continuing to rise in the first half of 2023 at a growth rate of about 16.6%. Gadobenate Dimeglumine Injection is developed by Italy's Bracco Imaging S.P.A. Currently, including the company, two enterprises have passed or been considered to pass the generic drug quality and efficacy consistency evaluation.

Beilu Pharmaceutical's product Gadobenate Dimeglumine Injection passing the evaluation of generic injectable drug quality and efficacy consistency is a recognition by the national drug regulatory authority of the company's research and development, production capabilities, and product quality. It has once again accumulated valuable experience for the company's future consistency evaluation work for other generic drugs, which is of positive significance for the enhancement of the company's research and development capabilities.