Online Learning Prep Group

Because it is used in human medicine, Atorvastatin API must be produced under strict international quality standards known as Current Good Manufacturing Practices (cGMP).

Manufacturers are regularly inspected by health authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Every batch of the API must be accompanied by a Certificate of Analysis (COA), which proves that the substance is pure, contains the correct amount of active ingredient, and is free from harmful impurities or heavy metals. These regulations ensure that every tablet a patient takes is safe and reliable.