| With the quick development of Chinese pharmaceutical, at present China has become the biggest production country and export country of active pharmaceutical ingredient in the world, and the antibiotics API is the most important part of pharmaceutical raw material. According to the statistic from the Western Medicines Department of Chinese Chamber of Commerce of Import&Export of Medicines and Health Products, in 2008 the total industrial output value of Chinese API is 185.4 billions RMB. Under so big production capacity and output, part of APIs which are produced by Chinese pharmaceutical enterprises is used by the domestic market, the other part is exported to other counties in the world to be used by pharmaceutical manufacturers in these counties. Although the Chinese medical market is very big, it is limited. The intensified competition in the domestic market makes more strong Chinese APIs manufacturers pay attention to the international market and export their APIs to the international market. But in the process of international trade, some countries may adopt trade protectionism and set some trade barriers to protect the development of domestic pharmaceutical industry, which result in that the Chinese APIs can only enter into some counties and areas with low threshold. As a result, the quality, price etc. of the Chinese APIs can not be improved and enhanced quickly.Another aspect, accompanying with China joining WTO the advantages of Chinese pharmaceutical manufacturers coming from scale production and low labor cost make the international pharmaceutical industry chain pay more attention and squint towards Chinese pharmaceutical industry. And more and more counties start to turn their sight to Chinese pharmaceutical industry, they collaborate with Chinese pharmaceutical enterprises by importing APIs, finished products directly from China or by OEM and other methods.As one of the biggest export market of Chinese current antibiotics APIs, the Europe medical market has big potential and has very important strategic meaning to Chinese APIs export in the future. But, only comparing with Indian pharmaceutical manufacturers, there are many faults and shortages of the APIs export of Chinese pharmaceutical enterprises to Europe market. Currently, there are more than 6 thousands pharmaceutical manufacturers in China, but the quantity of enterprises who can export their products to Europe market is very small because these high level markets are very strict to the entry of products due to the characteristics of pharmaceutical products. So the quantity of enterprises exporting their products to Europe market is much small, especially for the quantity of enterprises having products such as Ceftriaxone Soudium with big market and high added value. The main reason is that the discrepancies of culture background, language, laws, rules and requirements of medicines make the Chinese pharmaceutical manufacturers do not know how to export their products to this market. Although there are many professional consulting agencies in China and overseas who can help Chinese pharmaceutical manufacturers export their products to Europe market and more Chinese pharmaceutical enterprises have the ability to export to Europe market, the export of APIs to Europe market is a systemic and integrated program and project, furthermore the professional consulting agencies can not acquaint themselves with the internal facts of the enterprises, products characteristics and so on meanwhile the pharmaceutical manufacturers can not have enough knowledge and experiences on the requirements of export to Europe market, which dissever the integrated work of APIs export to Europe market. As a result, it is difficult to breach the technology and trade barriers of APIs export to Europe market.The author of this dissertation has long time work experiences in pharmaceutical enterprise, successively engage in production of pharmaceutical products, logistics management, and management of international trade of medicine, so he has much experiences in medicine export, is familiar with the requirements on pharmaceutical products export of different counties and areas, and enjoys a systematic perception and understanding of medicines export.The paper uses the export of Ceftriaxone Sodium API of Reyoung Pharmaceutical Co.,Ltd. to Europe market as an object of study to expatiate the quality requirements of Europe market on this product, the works required on GMP inspection, registration dossiers compiling and the obtaining of relevant certificates, meanwhile make a SWOT analysis on the export of Ceftriaxone Sodium of Reyoung Pharmaceutical Co.,Ltd. to Europe market. The purpose is hoping to find a feasible strategy for Reyoung Pharmaceitical Co.,Ltd to export its product to Europe market.This paper strive the integrating of theory with practice to make the study results not only apply Reyoung Pharmaceutical Co.,Ltd. but also provides reference and experiences to all the pharmaceutical manufacturers of China who want to export their products to Europe Market. |
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