【New Product】Beilu Pharmaceutical's Gadoteric Acid Meglumine Injection and API Approved

Recently, Beilu Pharmaceutical has received the "Drug Registration Certificate" for Gadoteric Acid Meglumine Injection and the approval notice for the marketing application of Gadoteric Acid Meglumine bulk drug from the National Medical Products Administration.

Gadoteric Acid Meglumine Injection is a macrocyclic gadolinium-based contrast agent and one of the commonly used MRI contrast agents in clinical practice. Additionally, Gadoteric Acid Meglumine Injection is classified as a Category B product under medical insurance. According to data from the PharmaDoodle database, the market sales of Gadoteric Acid Meglumine Injection exceeded 600 million yuan in 2023, representing a year-on-year increase of 31%.

The recent approval of the "Approval Notice for the Marketing Application of Chemical Bulk Drugs" for Gadoteric Acid Meglumine indicates that the raw material has met the relevant national technical standards for the evaluation of bulk drugs. After complying with the requirements of Good Manufacturing Practice (GMP) for drug production, it can be produced and sold in the domestic market and used for the production of related gadolinium-based contrast agent formulations.

Gadoteric Acid Meglumine Injection, approved as a Class 4 chemical drug, is deemed to have passed the evaluation of quality and efficacy consistency for generic drugs. Following the approval of Gadobutrol Injection, the approval of Gadoteric Acid Meglumine Injection further enriches the company's layout of macrocyclic gadolinium contrast agent products, making the contrast agent product line more diversified. The "bulk drug + formulation" business model for Gadoteric Acid Meglumine Injection has taken shape, and the company will actively carry out various preparations for the new product launch and strive to bring the product to the market as soon as possible.