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Moreover, ensuring the stability and safety of drug intermediates is paramount. Some intermediates may exhibit toxic properties or be difficult to handle, necessitating careful control of laboratory conditions and adherence to safety protocols. Pharmaceutical companies must continually assess the risk associated with these intermediates, not only for regulatory compliance but also for the safety of their end products.


Conclusion


API manufacturing can be divided into two primary categories chemical synthesis and biotechnological production. Chemical synthesis involves the transformation of raw materials into pharmaceuticals through various chemical reactions. This method can be highly efficient for small molecules and allows for scalability and flexibility in production. In contrast, biotechnological production, which includes the use of living organisms or cells to produce active ingredients, is primarily applicable in the production of large molecules such as proteins or monoclonal antibodies.


Conclusion


 

On the other hand, excipients are the non-active components of a drug formulation that serve as vehicles for the API. They may enhance the stability of the medication, aid in the manufacturing process, improve taste, or assist in the drug's absorption in the body. Common excipients include fillers, binders, preservatives, and flavoring agents. For instance, lactose is often used as a filler in tablets, while magnesium stearate serves as a lubricant during production. Although they do not provide therapeutic effects, excipients can influence the bioavailability and efficacy of the active ingredients, making their selection critical in drug formulation.


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