Active Pharmaceutical Ingredient (API) is the part of any drug that produces the desired effect. Some drugs, such as combination therapy, contain multiple active ingredients to treat different symptoms or work in different ways.
The production of active pharmaceutical ingredients has traditionally been done by pharmaceutical companies themselves in their home countries. However, in recent years, many companies have chosen to move their manufacturing operations overseas to reduce costs. With stricter guidelines and inspections in place, the regulation of these drugs has undergone significant changes.
All drugs have two core ingredients - the API, which is the active ingredient, and the excipient, which is any substance outside the drug that helps deliver the drug to your system. Excipients are chemically inert substances, such as lactose or mineral oil in a pill.
Manufacturers use certain standards to determine the strength of active pharmaceutical ingredients in each drug. However, standards may vary from one brand to another. Each brand may use different test methods, which may lead to different potencies.
In all cases, the FDA requires manufacturers to demonstrate the efficacy of their products in real-life patients as well as laboratory conditions.
While many pharmaceutical companies are located in the United States and the United Kingdom, most active pharmaceutical ingredient manufacturers are situated worldwide. The largest are in Asia, particularly India and China.
More and more companies are cutting costs on expensive equipment, employees, and infrastructure by outsourcing, but they remain concerned about the quality of active pharmaceutical ingredients produced overseas.
Currently, only 15% of active pharmaceutical ingredients are created in the United States, with plans in place to end this small percentage and outsource all manufacturing overseas.
The quality of active pharmaceutical ingredients has a significant impact on the efficacy and safety of drugs. Poorly manufactured or damaged active pharmaceutical ingredients are associated with serious issues, such as disease or death.
Even in the case of outsourcing, active pharmaceutical ingredients are subject to strict regulations and supervision from the country/region they are shipped to. For example, overseas raw material production plants are still subject to inspections from the US Food and Drug Administration.
As the creation of APIs has demonstrated, the pharmaceutical industry is undergoing rapid change. Companies are no longer handling every step of the pharmaceutical process. One company used to create APIs, manufacture capsules, and package the drugs - but no longer.
In response, regulatory agencies responsible for patient and public safety have implemented strict screening to ensure drug quality and prevent defects. Any violation of these established standards may result in manufacturers behind these pharmaceutical companies facing fines or costly recalls.