Recently,The first ceremony of Puli Pharmaceutical's gadolinium cloth alcohol injection exported to the United States was held in Puli Pharmaceutical's Hainan factoryHeldThe launch ceremony was reported by Hainan TV, China Daily, Haikou, Hainan News and other authorities. The export of gadolinium cloth alcohol injection will have a positive impact on the company's expansion into the international market.
Introduction to gadolinium cloth alcohol injection
Gadolinium cloth alcohol injection is a non-ionic contrast agent (GBCA) based on gadolinium magnetic resonance imaging (MRI), which is suitable for contrast contrast magnetic resonance imaging (CE-MRI) examination of lesions in all parts of the body (including cranial brain and spinal cord) and contrast magnetic resonance angiography (CE-MRA) examination of all parts of the body in ** and children of all ages (including full-term neonates). Gadolinium cloth alcohol injection has both high concentration and high relaxation rate, which combines the effectiveness and safety of contrast-enhanced imaging, which makes it show excellent performance in multi-system enhanced MR examination and enhanced MRA examination of the whole body, and can effectively improve the detection rate and diagnostic accuracy of small lesions.
After the successful development of gadolinium butrol injection, Puli Pharmaceutical submitted generic drug registration applications in the United States and China respectively, and received it this yearGadolinium cloth alcohol injection issued by the US FDA (specification: 7.)5ml:4.5354g,15ml:9.0708g) marketing authorization.
The U.S. market for gadolinium butrol injection reached 5.88 million pieces (sales accounted for 50% of the world's total).
IMS data shows (see figure below for details) that the global market for gadolinium cloth alcohol injection will exceed 3900 million US dollars, about 11.77 million, is expected to reach 4$500 million. It is worth noting that the United States, as the world's largest consumer market for gadolinium cloth alcohol injection, accounts for 1 3 percent of global sales, and the number of sales accounts for about 50% of global sales(5.88 million). Puli Pharmaceutical's gadolinium butrol injection is the second generic drug of this variety approved by the US FDAIt has strong market competitiveness.
At the same time,Gadolinium butrol injection is the second contrast agent product developed by Puli PharmaceuticalIn the process of applying for marketing in the United States, the product passed the first round of review by the US FDA within 10 months, which greatly compresses the review cycle, and in theThis year, it successfully passed the drug marketing approval of the U.S. Food and Drug Administration, indicating that the R&D level of contrast agent products of Puli Pharmaceutical has reached the international level.
In addition, Puli Pharmaceutical has developed a number of contrast agent products, basically covering computed tomography, digital subtraction, arteriography, magnetic resonance imaging and other fields, including iodopamol injection, gadolinium cloth alcohol injection, iohexol injection, iodophorol injection, iodineprol injection, gadolinium meglumine injection, gadolinium meglumine injection, gadolinium teretol injection, etc., in order to further develop the contrast agent market to make product reserves and strategic layout.
About Puli Pharmaceutical
Founded in Haikou in 1992, Hainan Puli Pharmaceutical Co., Ltd. is a leading enterprise in the internationalization of China's pharmaceutical preparations and an intelligent manufacturing demonstration enterprise of the Ministry of Industry and Information Technology of the People's Republic of China, and has been included in the key project of industrial transformation and upgrading of Made in China in 2025 by the Ministry of Industry and Information Technology. After being listed on the Growth Enterprise Market in 2017, it has become one of the top 100 scientific and technological innovation enterprises of listed companies in China in just three years.
Since the company has been engaged in the internationalization of drugs, it has obtained more than 150 international marketing authorizations, and its products are exported to all over the world.
In the future, Puli Pharmaceutical will continue to implement the global strategy of "advanced high-end manufacturing, domestic and international", and continue to develop more and better drugsGo to the world, contribute to the strength and continuous development of the national pharmaceutical industry, and let the Chinese people use high-quality drugs exported to Europe and the United States.
High quality, made by Puli!