API & Raw Materials
API
Medicines contain various substances. The substance that causes the effect of the medicine is called the ‘active substance’ or ‘Active Pharmaceutical Ingredient’ (API). To ensure that patients or users receive safe and effective medicines, manufacturers, importers, and distributors of active substances must comply with several regulations.
The legislation and regulations establish requirements for companies that utilise Active Pharmaceutical Ingredients (APIs). These requirements concern a good way of producing, importing and distributing. This should ensure that active substances are of good quality and that counterfeit active substances do not enter the legal circuit.
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