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Despite their importance, the production of pharmaceutical intermediates is not without challenges. The increasing complexity of drug formulations necessitates a greater diversity of intermediates, which can strain existing manufacturing processes. Additionally, regulatory demands are ever-tightening, necessitating adherence to good manufacturing practices (GMP) and environmental considerations.


The pharmaceutical industry is one of the most highly regulated sectors globally. Manufacturers must comply with guidelines from organizations such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These guidelines dictate everything from facility standards to documentation of manufacturing processes and product testing.


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