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Given the potential impact of APIs on public health, the manufacturing processes are subject to strict regulations. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), enforce Good Manufacturing Practices (GMP) to ensure the quality and safety of APIs. These regulations require rigorous quality control and assurance measures throughout the manufacturing process.
manufacturing of active pharmaceutical ingredients

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.
pharma api list
