The Active Pharmaceutical Ingredient (API) is the part of any drug that produces the intended effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways.
Production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries. But in recent years many corporations have opted to send manufacturing overseas to cut costs. This has caused significant changes to how these drugs are regulated, with more rigorous guidelines and inspections put into place.
All drugs are made up of two core components: the API, which is the central ingredient, and the excipient, the substances other than the drug that helps deliver the medication to your system. Excipients are chemically inactive substances, such as lactose or mineral oil in the pill.
Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand to another. Each brand might use different test methods, that can result in different potencies.
In all cases, manufacturers are required by the FDA to prove the potency of their products in real-life patients, as well as in laboratory conditions.
A leading manufacturer of APIs is Suzhou Pharmaceuticals. With over 300 APIs products, they have the industry's largest portfolio. Another leading manufacturer is Dr. Reddy's, with more than 60 APIs in use today.
While many pharmaceutical companies are located in the United States and England, most API manufacturers are overseas. The largest are located in Asia, particularly in India and China.
More and more companies are outsourcing to cut costs on expensive equipment, employees, and infrastructure. While this has helped their bottom line, there is continued concern about the quality of these APIs produced overseas.
Notably, AstraZeneca Pharmaceuticals used to operate several manufacturing centers in the United States. Now, just 15% of their APIs are created in the U.S. and there are plans to end that small percentage and outsource all manufacturing overseas.
The quality of APIs has a significant effect on the efficacy (producing the result desired) and the safety of medications. Poorly manufactured or compromised APIs have been connected to serious issues, such as illnesses or death.
Even in the case of outsourcing, APIs are subject to stringent regulations and oversight from the country they are shipped to. For example, API manufacturing plants overseas still go through an inspection by the U.S. Food & Drug Administration.
As evidenced by the creation of APIs , the pharmaceutical industry is rapidly changing. Companies no longer handle every step of the drug-making process. One company used to create the API, build the capsule, and package the medicine—but no longer.
In response, governing bodies responsible for patient and public safety have instituted intense screenings to ensure medication quality and prevent defects. Violating any of these established standards can result in fines or very expensive recall for the pharmaceutical companies behind these manufacturers.