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One of the primary roles of pharmaceutical intermediates manufacturers is to ensure a steady supply of these critical compounds. The manufacturing process requires precision and a high degree of technical expertise. Each intermediate must be produced under stringent quality control measures to meet regulatory standards enforced by authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance with Good Manufacturing Practices (GMP) is essential, ensuring that intermediates are produced consistently and safely.
Once an API has demonstrated its potential through clinical trials, pharmaceutical companies must then ensure that it can be manufactured at scale without compromising its quality. This step often involves the establishment of Good Manufacturing Practices (GMP), which dictate the standards for the production of APIs to guarantee that they meet the necessary quality parameters.
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