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The Role of API Drug Manufacturers in the Pharmaceutical Industry

Natural APIs are derived from natural sources, including plants, animals, and minerals. These compounds are often extracted and purified to create medications. Prominent examples include morphine from opium poppies and digoxin from foxglove plants. Natural APIs have a long history of use in traditional medicine, and they continue to inspire modern pharmaceutical development. Despite their potential, natural APIs can vary in potency and purity, making standardization a challenging aspect of their development.

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Once synthesized, intermediates must undergo purification processes, such as crystallization or chromatography, to eliminate impurities and by-products. Quality control is paramount in this industry; every batch of intermediates must be rigorously tested to meet stringent regulatory standards set forth by agencies like the FDA or EMA. This ensures that only high-quality intermediates are used in the production of APIs, safeguarding patient health.