active drug substance
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CoQ10, also known as ubiquinone, is a naturally occurring antioxidant present in the body, predominantly within the mitochondria. It plays a key role in the production of adenosine triphosphate (ATP), the energy currency of our cells. As we age, CoQ10 levels tend to decline, leading to reduced energy production and increased susceptibility to oxidative stress.
pqq & coq10...
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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.
api drug meaning...