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Intermediates refer to the intermediate products in the synthesis of compounds. Pharmaceutical intermediates are chemical raw materials or products used in the synthesis process of active pharmaceutical ingredients; they do not require a license for the production of active pharmaceutical ingredients, and can be manufactured in ordinary chemical plants. As long as they meet certain standards, they can be used in the synthesis of active pharmaceutical ingredients. 1. The custom manufacturing process in the pharmaceutical intermediates industry: Custom products are divided into 3 levels depending on the degree of collaboration with clients: (1) Participating in the client’s new drug development phase, which requires the company’s R&D center to have strong innovation capabilities ； (2) Scaling up the customer’s pilot-scale products to develop a manufacturing process suitable for large-scale production requires the company to have the capability to engineer such products on a larger scale, as well as the ability to make ongoing process improvements to customized products, in order to meet the demands of large-scale production, continuously reduce production costs, and enhance the competitiveness of the products ； The pharmaceutical intermediates industry can provide customized synthesis services for intermediates based on customer requirements. (3) Optimize and improve the manufacturing processes for products in the customer’s large-scale production phase, so as to meet the quality standards of foreign companies. Medici offers custom synthesis services, enabling it to design synthetic routes for clients’ target molecules and to complete the synthesis of these compounds on time, with high quality and in the required quantities. These compounds include control compounds, metabolites, reagents, intermediates, molecular fragments, and impurities. 2. Difference between pharmaceutical intermediates and active pharmaceutical ingredients: Both pharmaceutical intermediates and active pharmaceutical ingredients fall under the category of fine chemicals. Intermediates are substances that are produced during the manufacturing process of active pharmaceutical ingredients; they require further molecular transformations or purification before they can become active pharmaceutical ingredients. Intermediates can be separated from the final product or left unseparated. (Note: This guide covers only the intermediates produced after what the company defines as the starting point of active pharmaceutical ingredient production. ) Active pharmaceutical ingredient (API): Any substance or mixture of substances intended for use in the manufacture of drugs, and which, when used in pharmaceuticals, becomes an active ingredient of the drug. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, management, or prevention of diseases, or they can affect the functions and structure of the body. The active pharmaceutical ingredient is the product that has completed the synthesis pathway and is active, while an intermediate is a product at some point along the synthesis pathway. The active pharmaceutical ingredient can be formulated directly, while intermediates can only be used to synthesize the next stage of products; it is only through intermediates that the active pharmaceutical ingredient can be produced. data:image/png;base64,/9j/4AAQSkZJRgABAQEAYABgAAD/2wBDAAoHBwkHBgoJCAkLCwoMDxkQDw4ODx4WFxIZJCAmJSMgIyIoLTkwKCo2KyIjMkQyNjs9QEBAJjBGS0U+Sjk/QD3/2 wBDAQsLCw8NDx0QEB09KSMpPT09PT09PT09PT09PT09PT09PT09PT09PT09PT09PT09PT09PT09PT09PT09PT09PT3/wAARCAECAeYDASIAAhEBAxEB/8QAHwAAAQUBAQEBAQEAAAAAAAAAA AECAwQFBgcICQoL/8QAtRAAAgEDAwIEAwUFBAQAAAF9AQIDAAQRBRIhMUEGE1FhByJxFDKBkaEII0KxwRVS0fAkM2JyggkKFhcYGRolJicoKSo0NTY3ODk6Q0RFRkdISUpTVFVWV1hZWmNkZ WZnaGlqc3R1dnd4eXqDhIWGh4iJipKTlJWWl5iZmqKjpKWmp6ipqrKztLW2t7i5usLDxMXGx 8jJytLT1NXW19jZ2uHi4+Tl5ufo6erx8vP09fb3+Pn6/8QAHwEAAwEBAQEBAQEBAQAAAAAAA AECAwQFBgcICQoL/8QAtREAAgECBAQDBAcFBAQAAQJ3AAECAxEEBSExBhJBUQdhcRMiMoEIFEKRobHBCSMzUvAVYnLRChYkNOEl8RcYGRomJygpKjU2Nzg5OkNERUZHSElKU1RVVldYWVpj 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have different structures from APIs. Additionally, the pharmacopoeia includes testing methods for the active pharmaceutical ingredients, but not for the intermediates. Speaking of certification, the FDA currently requires intermediates to be registered, while this is not necessary for COS; however, the CTD documents must contain a detailed description of the manufacturing process for the intermediates. In China, there are no mandatory GMP requirements for intermediates. Pharmaceutical intermediates do not require a production license like active pharmaceutical ingredients; the entry barrier is relatively low, and competition is fierce. Therefore, quality, scale, and management level are often the fundamentals for a company’s survival and development. Moreover, increasing environmental regulations are causing many small businesses to withdraw from the competition, which is likely to lead to a rapid increase in industry concentration. It is generally believed that the following three areas will be key for related companies to improve their profitability, increase added value, and achieve sustainable growth: (1) Product diversification and upgrading, shifting from the production of low-end intermediates on an extensive scale to the production of high-end intermediate products with higher precision ； (2) Adopt the path of professional outsourcing services, continue to expand within the outsourcing service industry chain, and undertake R&D outsourcing services ； (3) Focus on the pharmaceutical industry, advancing toward active pharmaceutical ingredients and finished drugs downstream from intermediates.