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For the global pharmaceutical market, taxol is a product with market value of $ 3,000,000,000. At present, there are two global permissions of the taxol clinical applications, namely paclitaxel and docetaxel. The raw materials are extracted from plants. However, as it is limited by increasingly scarce natural resources. The requirements of paclitaxel producing by organic synthetic means become increasingly urgent. From the current situation, the driving force of global paclitaxel and docetaxel API market from generic manufacturers and specialty pharmaceutical companies and medical device companies. Generic drug companies to develop paclitaxel, the stability of pharmaceutical raw materials prices and the supply chain are naturally an essential success factor, and to avoid patent infringement, as well as the time delay is also crucial. For the development of new formulations of paclitaxel medical technology company, they all hope to enhance the value of the products and the sales price by the preparation technique to improve the final product chia seed can be increased in the clinical advantages as well as the industrialization process of new product development process The core content. To this end, the stability of the prices of raw materials from the source of taxol is naturally one of the factors that these enterprises are most concerned about. With the growth in demand and price pressures in the synthesis of paclitaxel extraction process, a balance must be found to achieve the final goal of economic and stable supply. R & D and early market stage, paclitaxel is mainly extracted from the plant taxane, which is the polycyclic diterpene class of plant extracts in the cancer field. With paclitaxel in Europe and the United States patents have expired, the second product of the taxol family docetaxel has become the star products in the cancer field. From the chemical structure of paclitaxel and docetaxel overall very similar, they were different in the main ring and the side chain. Taxol is a presence in natural plant chemicals, which it was originally the production process and is extracted from these plants, bark, roots, needles, or stems, but now, with new technology advances, even if its production still needs to come from plant extracts, but has been through a semi-synthetic method of preparation, the dependence on natural resources has eased. With paclitaxel, docetaxel is not a natural substance, therefore, it is necessary to produce semi-synthetic resveratrol, similar to its mode of production with paclitaxel semi-synthetic preparation methods. Success is based on the European and American markets, the stability of supply, the high purity of the product and the production of GMP standard is essential. In recent years, due in Europe in this regard to strengthen the legislative work, the production of the API GMP norms is even more important. In this sense, the stability of these two factors in addition to considering the economic and raw material supply, paclitaxel way in which the preparation of purity and quality standards is a very critical issue. It is worth mentioning that docetaxel compound patent is about to reach expire. The important anti-tumor products with annual sales exceeding $ 1 billion have become the generic object coveted by the generic manufacturers. As the current public docetaxel production process is still monopolized by the original researchers with patent protection, thus, how to break the patent barriers and find a cost-effective synthetic route have become a new opportunities and challenges for generic drug companies to Source:http://www.cospcn.com
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