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Despite the clear advantages of importing APIs from China, there are notable challenges that pharmaceutical companies must navigate. Regulatory compliance is a significant concern, as the FDA and other regulatory bodies impose strict guidelines on the quality and safety of imported APIs. Companies must conduct thorough due diligence when selecting suppliers to ensure that they comply with Good Manufacturing Practices (GMP) and other international standards.


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Understanding APIs


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After production, APIs must be carefully packaged to preserve their stability and potency. Packaging also involves compliance with regulatory standards, ensuring that all labels accurately reflect the content, usage, and safety warnings. Once packaged, the APIs are distributed to various pharmaceutical companies that will formulate them into final dosage forms, such as tablets or injectables.


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