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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.
api drug substance

Quality control is an integral part of API production. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), impose stringent guidelines to ensure that APIs meet established standards. Compliance with Good Manufacturing Practices (GMP) is mandatory to maintain the quality and consistency of APIs. Furthermore, the analytical techniques employed, such as chromatography and spectroscopy, play a vital role in verifying the identity, strength, and purity of the APIs.
api in drug manufacturing
