What Is an Active Pharmaceutical Ingredient (API)?

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 Federal Drug Administration (FDA) guidelines and inspections put into place. 

Components of Medications

All drugs are made up of two core components—the API, the central ingredient, and the excipient, the substances other than the drug that help deliver the medication to your system. Excipients are chemically inactive substances, such as lactose or mineral oil in the pill, reports Molkem, chemical exporter.

Strength of APIs

Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand and process 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.

Top API Manufacturers

A leading manufacturer of APIs is TEVA Pharmaceuticals.Another leading manufacturer is Dr. Reddy's.

Other industry giants are Pfizer, Novartis, Sanofi, Boehringer Ingelheim, and Bristol-Meyers Squibb. Each of these companies specializes in different APIs, with some offering generic products as well.

Where Are APIs Made?

While many pharmaceutical companies are located in the United States and England, most API manufacturers are overseas. Other than the U.S., the largest are located in Asia, particularly in India and China, according to the FDA.

More and more companies are outsourcing to cut costs on expensive equipment, employees, and infrastructure, according to Beroe, procurement alliance and supplier compliance, company. While this has helped their bottom line, there is continued concern about the quality of these APIs produced overseas.