API (Active Pharmaceutical Ingredient) refers to a substance or substance combination used in manufacturing a drug product. API also refers to the active or central ingredient in the product which causes the direct effect on the disease diagnosis, prevention, treatment or cure. While API is the active component of a drug, excipients are the inactive or inert substances present in a drug.
An API starting material, usually a defined chemical property purchased in the market place or produced in-house, is used in the production of an API.
API drug manufacturing, storage and packaging is subject to Current Good Manufacturing Process (CGMP) regulations enforced by the U.S. Food and Drug Administration and international regulatory agencies.
Manufacturers generally determine the relative strength of an API using a standard method of measurement and calculation. The methods of standardizing the strength of a medication can vary from brand to brand.
According to analysts with TechNavio, a market research company, global sales of APIs are expected to grow 7.9 percent between 2011 and 2015 in North and South America, and EMEA and APAC regions.
Experts say the growth in new medical technologies are spurring the demand for APIs, along with the increased importation of raw pharmaceutical ingredients from emerging markets. China and India supply more than 40 percent of APIs used in pharmaceuticals sold in the United States, according to Boehringer Ingelheim. Analysts with the corporation predict the two counties could be supplying 80 percent of U.S. pharmaceuticals’ API within the next 10 years. The FDA is responsible for inspecting facilities that manufacture APIs domestically and internationally.