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1. Quality of Products The quality of chemicals supplied is of utmost importance. High-quality products lead to better performance and reduced operational issues. Suppliers should provide data sheets and certifications for their chemicals to assure clients of their efficacy and safety.
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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...