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Furthermore, excipients can significantly influence the manufacturing process. The choice of excipients can affect the flow properties of powder mixtures, compressibility, and overall manufacturability of the final product. In this regard, careful selection of excipients is essential to ensure a consistent and reliable drug product. Additionally, some excipients are designed to mask the taste of bitter APIs, making medication more acceptable for patients, especially children.


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Potential Risks


3. Regulatory Compliance Adhering to local and international regulations is essential to prevent legal issues and ensure market access.


API suppliers must adhere to stringent regulatory standards set forth by authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulatory bodies impose comprehensive guidelines to ensure that APIs meet the required standards for safety, efficacy, and quality. Non-compliance can lead to significant financial losses and damage to a company’s reputation.


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