The active pharmaceutical ingredient (API) is the part of any drug that produces the desired effects. Some medicines, such as combination therapies, contain more than one active ingredient to treat different symptoms or work in different ways.
The production of APIs has traditionally been carried out by the pharmaceutical companies themselves in their country of origin. But in recent years, many companies have chosen to send manufacturing overseas to reduce costs. This has resulted in significant changes in the way these drugs are regulated, with the introduction of more rigorous guidelines and inspections by the Federal Drug Administration (FDA).
All drugs are made up of two main components: API, the central ingredient, and the excipient, the non-drug substances that help deliver the drug to your system. Excipients are chemically inactive substances, such as lactose or mineral oil in the pill, reports chemical exporter Molkem.
Manufacturers use certain standards to determine the strength of API in each drug. However, the standard can vary considerably from one brand and from one process to another. Each brand may use different testing methods, which may result in different potencies.
In all cases, manufacturers are required by the FDA to prove the potency of their products in real patients, as well as under laboratory conditions.
Major API Manufacturers
One of the main API manufacturers is TEVA Pharmaceuticals. Dr. Reddy’s is another leading manufacturer.
Other industry giants are Pfizer, Novartis, Sanofi, Boehringer Ingelheim and Bristol-Meyers Squibb. Each of these companies specializes in different APIs, with some also offering generic products.
Where are APIs made?
While many pharmaceutical companies are located in the United States and England, most of the API manufacturers are overseas. Apart from the United States, the most important are located in Asia, notably in India and China, according to the FDA.
More companies are outsourcing to reduce the costs of expensive equipment, employees and infrastructure, according to Beroe, a sourcing and supplier compliance alliance company. While this helped their results, the quality of these internationally produced APIs continues to be a cause for concern.