Abstract
Each and every formulation, whether it belongs to food or the pharmaceutical industry is comprised of an assortment of the ingredients along with the key active bioactive. The ingredients also termed as “formulation additives” were generally regarded to be inactive in nature and play vital roles in the development of final formulation. Notably, due to some latest tragic incidences, their importance came into the limelight and different regulatory bodies started focusing on the additives, which resulted in different regulatory guidelines relating to the quality, purity, storage, analysis, utilization, and many more aspects of additives. Due to the regulations on additives, a term came out, i.e., Generally Recognized As Safe which included a number of ingredients having no side effects when used within the specific limits according to the mentioned guidelines. This chapter emphasizes the different regulatory aspects of the additives utilized in the pharmaceutical industry.
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