Beijing Beilu Pharmaceutical Co., Ltd. (300016) announced today that Gadobutrol injection has obtained the "Drug Registration Certificate" issued by the NMPA（National Medial Production Administration）.
Gadobutrol injection was approved according to Category 4 chemicals, which is deemed to have passed the Quality and Efficacy Consistency Evaluation of generic drugs. The company's contrast agent product line is also more diversified.
Because of its high relaxation, high concentration, and high stability (macrocyclic structure), Gadobutrol injection has become a leader in magnetic resonance contrast agents with both excellent imaging and high stability. It is suitable for adults and all ages of children (including full-term neonates), it can be used for enhanced magnetic resonance examination of lesions in various parts of the body (including the brain and spinal cord), among which dynamic magnetic resonance angiography (DCE-MRA) and dynamic magnetic resonance enhanced examination of various parts of the body (DCE-MRI) have more advantageous.
As a professional contrast agent supplier, Beilu Pharma launched the first domestic magnetic resonance contrast agent Gadopentetate Dimeglumine injection in 1992, which has been widely praised by the industry for many years. At present, in addition to the original research product - Gadovist, only two companies including Beilu Pharma have been approved for Gadobutrol injection in China. The company will actively carry out various preparations for the launch of new products, and bring the products to the market as soon as possible.