Complete the first stage of trial production of "citalopram hydrobromide"
The results are encouraging.The Group's pharmaceutical material factory in Jiangsu "- Jiangsu Jihualing implemented Phase -- trial production of the company's first product "citalopram hydrobromide"The whole line will be completed with citalopram hydrobromide pilot synthesis process and supplemented according to FDA requirements Improve the purpose of relevant process parameters to obtain citalopol hydrobromide that meets the USP standard of the United States Blue products. At present, the workshop is actively preparing for the second stage of large-scale production area according to the company's deployment The commissioning work is being carried out in an orderly manner; It is expected that the official delivery will be made to the FDA in the fourth quarter Submit DMF application documents, and realize the formal production and sales of products; Q2 2007 Obtaining national GMP certification; From the end of 2007 to the beginning of 2008, it obtained FDA certification.
According to the latest survey results released by the World Health Organization (WHO) The incidence of depression is 3.1%. At present, there are about 340 million depression patients in the world, and in the future In 20 years, depression will become the second most common disease in the world. As the main anti One of the depression drugs, citalopram hydrobromide is known as "the most pure serotonin reuptake Inhibitor (SSRI) ", it can be seen that it has broad market demand prospects. Citalopram The key markets of are concentrated in North America and Europe, while other regions have less market shares because The Group introduces new technologies from Europe and the United States to the product, strengthens the competitiveness of the product and enables it to have a starting point Higher, more advanced production technology, product quality in line with the USP2009 standard and other advantages, To ensure that product quality meets customer needs. As the only company applying for this product in China For manufacturers that have submitted for FDA certification, the target market of enterprises is wider and the scope of selection is wider.With the effective promotion of trial production, the Marketing and Sales Department has also gradually deployed the sales strategy earlier Actively explore domestic and foreign markets.