api active pharmaceutical
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PQQ, a redox cofactor that is naturally present in the body and found in foods like spinach, green peppers, and fermented soybeans, has emerged as a potent mitochondrial protectant. Preliminary studies suggest that PQQ may enhance mitochondrial biogenesis, the process by which new mitochondria are formed within cells. This could be particularly beneficial in situations where mitochondrial function is compromised, such as in aging or chronic disease.
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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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