【New Product】Approval of Gadopentetate Dimeglumine Injection and Chemical Raw Materials by Beilu Pharmaceutical

Recently, Beilu Pharmaceuticals received the Drug Registration Certificate for Gadopentetate Dimeglumine Injection and the approval notice for the marketing application of Gadopentetate Dimeglumine as a chemical raw material issued by the National Medical Products Administration.

Gadopentetate Dimeglumine Injection is a macrocyclic gadolinium-based contrast agent, commonly used in clinical MRI examinations. It is also classified as a Category B product under the medical insurance scheme. According to the Yaozhi database, the market sales for Gadopentetate Dimeglumine Injection exceeded 600 million yuan in 2023, marking a year-on-year growth of 31%.

This approval notice for the marketing application of the Gadoteric Acid Meglumine raw material drug signifies that the raw material meets the national technical standards for raw material drug evaluation. After meeting the Good Manufacturing Practice (GMP) requirements, it can be produced and sold in the domestic market and used in the production of related gadolinium-based contrast agent formulations.

Gadopentetate Dimeglumine Injection was approved under the category of chemical drugs, which is considered equivalent to passing the evaluation of generic drug quality and efficacy consistency. Following the approval of Gadoteridol Injection, the approval of Gadopentetate Dimeglumine Injection further enriches the company's portfolio of macrocyclic gadolinium-based contrast agents and diversifies its contrast agent product line. The "raw material + formulation" business model for Gadopentetate Dimeglumine Injection has taken shape. The company will actively prepare for the launch of the new product and bring it to market as soon as possible.