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API manufacturing can be divided into two primary categories chemical synthesis and biotechnological production. Chemical synthesis involves the transformation of raw materials into pharmaceuticals through various chemical reactions. This method can be highly efficient for small molecules and allows for scalability and flexibility in production. In contrast, biotechnological production, which includes the use of living organisms or cells to produce active ingredients, is primarily applicable in the production of large molecules such as proteins or monoclonal antibodies.


After successful preclinical trials, the API enters clinical development, where it is tested in a series of progressively larger phases in human subjects. Each phase is designed to gather more data about the drug's safety and effectiveness. Depending on the results of these studies, the drug may eventually receive approval from regulatory bodies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), paving the way for commercial production.


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The global market for pharma intermediates is also influenced by factors such as globalization and technological advancements. As pharmaceutical companies increasingly operate in a globalized economy, the sourcing and production of intermediates have moved beyond traditional borders. Countries like India and China have emerged as major players in the production of pharma intermediates due to their cost-effective manufacturing processes and skilled workforce. This shift has allowed for increased access to a wide range of intermediates, promoting competition and driving down costs for pharmaceutical manufacturers.


2. Biotechnology Biopharmaceuticals, including monoclonal antibodies and therapeutic proteins, are produced using living organisms. This process often involves recombinant DNA technology, making it possible to produce complex biological molecules.


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