Application of Green Chemistry in the Active Pharmaceutical Ingredients Manufacturing

The application of Green Chemistry principles in the Active Pharmaceutical Ingredients (API) production is extremely important, aiming to minimize or eliminate the generation of toxic substances during the chemical processes, to reduce costs and the negative environmental impact. As the pharmaceutical sector has the purpose of promoting health, it is expected its activities do not result in a significant impact on the environment and human health, so that the adequacy of the processes employed becomes mandatory for its survival and viability. In the development of new drugs, the API's synthesis processes should ideally be elaborated, from the beginning, based on the principles of Green Chemistry, thus avoiding future additional expenses and regulatory difficulties with its alteration. For products registered with the regulatory agency, changing the API's manufacturing process to a more eco-friendly one demands time and financial resources for both the manufacturer and the pharmaceutical industry in order to meet regulatory requirements and ensure quality of the final pharmaceutical product. Despite this, efforts must be made in favor of sustainability and of environmental protection. This article describes the concept and principles of Green Chemistry, the importance of its application in the API manufacturing and exemplifies API's manufacturing processes based on these principles.