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Moreover, real-time stability studies are conducted under recommended storage conditions. These long-term studies are essential as they help to validate the findings from accelerated studies, providing a comprehensive understanding of how the API will function during its intended shelf life. The data obtained from these stability tests inform pharmaceutical manufacturers about necessary measures for handling, packaging, and labeling, ensuring that the needs of regulatory agencies, such as the FDA or EMA, are met.
Another challenge is the global supply chain management of APIs. Many pharmaceutical companies rely on outsourcing API production to countries with lower manufacturing costs, like India and China. While this practice can reduce costs, it also exposes companies to risks such as supply disruptions, quality control issues, and geopolitical factors. In recent years, the COVID-19 pandemic underscored these vulnerabilities, prompting many companies to seek local production options or diversify their suppliers.
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