On the evening of September 14, Tianyao announced that the company received the CEP certificate (European Pharmacopoeia Applicability Certification Certificate) issued by the European Drug Quality Administration on valine APIs. This is the first CEP certificate obtained by the amino acid APIs under Tianyao Pharmaceutical Co., Ltd., which has achieved a breakthrough of zero in the company's amino acid products entering the mainstream market of developed countries.
The announcement shows that valine (Valine), chemical name 2-amino-3-methylbutyric acid, belongs to the branched chain amino acid, is one of the 20 amino acids that make up proteins, is an essential 8 amino acids and sugar-generating amino acids, it works together with two other high-concentration amino acids (isoleucine and leucine) to promote normal growth of the body, repair tissues, regulate blood sugar, and provide the required energy. During intense physical activity, valine provides additional energy to the muscles to produce glucose to prevent muscle weakness. It can also be used as a therapeutic agent to speed up wound healing.
It is understood that CEP is one of the highest threshold drug certifications in the world, and it is also a passport for drugs to enter the EU market. CEP is recognized not only by all EU members, but also by other countries that have signed bilateral agreements, such as Canada, Australia, etc.
This time, tianyao co., LTD. valine API obtained the CEP certificate, which also obtained the access qualification of the European market and other regulated markets that recognize the CEP certificate. At the same time, this also means that the market of hundreds of millions of dollars is opened to Tianyao Shares. According to the PDB drug comprehensive database, the global sales of valine preparations in 2019 were 1.871 billion US dollars, corresponding to 319 tons of raw material consumption; in 2020, the global sales of valine preparations were 1.938 billion US dollars, corresponding to 331 tons of raw material consumption.
In recent years, Tianyao has been actively implementing the whole industrial chain layout of "API + preparation" with corticosteroids and amino acid drugs as the core, and the API business sector is one of its important sources of income. Among them, in terms of corticosteroid APIs, Tianyao Has the Leading Advantage, and its prednisone, spironolactone, dexamethasone, methylprednisol and other corticosteroid APIs products have passed the US FDA certification, with 9 European CEP certificates, and product sales cover more than 70 countries and regions in Asia, the Americas, Europe and so on. In terms of amino acid APIs, Tianyao Co., Ltd. has 23 varieties with an annual output capacity of more than 2500 tons, and has entered overseas sales markets such as Russia and Uzbekistan. This time, the CEP certificate obtained by Tianyao Co., Ltd. has brought a positive impact on the expansion of its amino acid products into the international market.