validation of active pharmaceutical ingredients

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The pharmaceutical intermediate market plays a crucial role in the global healthcare system by acting as a bridge between raw materials and the final pharmaceutical products. Pharmaceutical intermediates are chemical compounds that are used during the production of active pharmaceutical ingredients (APIs). This sector is critical for the drug manufacturing process, as these intermediates are essential for synthesizing complex organic compounds that are required in the formulation of medicines.


The Role of API in Drug Manufacturing


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Regulatory bodies globally, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), play a pivotal role in overseeing the production and distribution of APIs. They establish guidelines to ensure that APIs meet the necessary safety and efficacy standards before they can be included in pharmaceutical products. These regulations also help combat issues such as adulteration and counterfeiting, which pose significant risks to public health.


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