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Regulatory agencies, such as the FDA or EMA, have established guidelines outlining the testing and approval processes for light-sensitive drugs. These guidelines require comprehensive stability studies that assess how the API stands up against light exposure over time. Such studies not only confirm the drug's shelf life but also assist in determining optimal storage conditions and packaging requirements.


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Moreover, DMClU has been investigated for its potential antiviral properties. Compounds similar to DMClU have shown efficacy against various viruses by inhibiting viral replication. The mechanism generally involves competition with normal uracil for incorporation into RNA, leading to faulty viral genomes and impaired viral propagation.


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Despite advancements in technology and rigorous regulations, the manufacturing of APIs faces several challenges. One significant challenge is the increasing pressure for cost reductions without compromising quality. Outsourcing manufacturing to countries with lower labor costs has become common, but this can intensify concerns over quality control and regulatory compliance. Companies must balance cost-effectiveness with the necessity of upholding high standards.


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