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Once the API has passed QC and QA checks, it must be submitted for regulatory approval. This involves compiling extensive documentation demonstrating that the API is safe, effective, and manufactured according to the highest standards. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), review this information before granting approval for the API to be used in drug formulations.


The emergence of specialty APIs also reflects the diversification within the pharmaceutical industry. Drugs produced from specialty APIs are often used for treating rare diseases or specific conditions and can be quite complex. The production of these APIs requires specialized facilities, and companies often invest heavily in research and development to bring these innovative products to market. For example, Sofosbuvir, an API used in the treatment of Hepatitis C, is an important specialty API that has revolutionized the management of this viral infection.


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