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The production and quality of APIs are stringently regulated by health authorities around the world, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These organizations demand that APIs meet specific standards for purity, potency, and stability to ensure that healthcare professionals can provide safe and effective treatments.


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Despite advancements in technology and processes, API manufacturing faces several challenges. One of the main issues is the need for rigorous compliance with regulatory requirements. Ensuring that facilities meet GMP standards and passing inspections is a constant challenge for manufacturers. Non-compliance can lead to costly delays, product recalls, and reputational damage.


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