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After successful clinical trials, the next step involves scaling up the production of the API to meet regulatory standards. This phase is highly regulated by authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), which require extensive documentation regarding the manufacturing process, purity, and stability of the API. Compliance with Good Manufacturing Practices (GMP) is crucial, as it ensures the quality and safety of the pharmaceutical product.
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Moreover, PQQ has potent antioxidant properties, which means it helps neutralize free radicals in the body. Free radicals are unstable molecules that can cause oxidative stress, leading to cellular damage and contributing to the aging process and various diseases. By combating oxidative stress, PQQ plays a vital role in protecting the body from chronic diseases such as heart disease, diabetes, and neurodegenerative disorders.
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