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An API can be defined as a compound that is biologically active and is used in the formulation of drugs. It is the core component that provides the desired therapeutic effect. For instance, in a pain-relieving medication, the API might be acetaminophen. The other components in the formulation, known as excipients, are inactive substances that serve as carriers for the API or enhance the stability, solubility, and delivery of the drug.


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The production and approval of APIs and drug products are subject to rigorous regulatory oversight to ensure their safety and efficacy. In the United States, the Food and Drug Administration (FDA) is the primary regulatory body that governs the approval of new drugs and APIs. Manufacturers must adhere to Good Manufacturing Practices (GMP), which are guidelines that ensure that products are consistently produced and controlled according to quality standards.


Aug-14-2023

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Light-sensitive APIs can undergo photodegradation, leading to the formation of inactive or harmful byproducts. This process is especially critical in the pharmaceutical industry, where the stability of a drug can significantly impact its efficacy and safety. Compounds such as certain antibiotics, vitamins, and chemotherapy agents fall into this category, necessitating specific measures to protect them from light during their life cycle.


 

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