Active Pharmaceutical Ingredients (API)

Commercial medications contain an Active pharmaceutical ingredient (API), or the substance that exerts its therapeutic and pharmacologic activity on the: cure, diagnosis, treatment, disease mitigation, specific body part, and prevention of diseases.

Some medications may have multiple combinations of drugs, thereby having different active pharmaceutical ingredients. Some may actually vary in effect depending on the relative dose given to the body.

All commercial drugs are composed of two aspects: the Active Pharmaceutical Ingredient and Excipients. The API is the chemically active substance that exerts its intended effect on the consuming hosts while the excipients are the inactive component of the drug. An example of excipients includes the liquid where the API is dissolved or the sugar flavoring that enhances its flavor and tolerability.

Most patients on multiple therapeutic drugs are unaware of the specific API of each medicine that he takes. These medicines that are orally taken can have the potential of interacting one another within the body system. This is called drug interactions in therapeutics; drug interactions may augment drug action, retard its action, or may have adverse effects that could be potentially serious.

The APIs are also referred to as bulk pharmaceuticals where they are usually produced in bulk powder form from a distant source or country. These raw materials are used to manufacture the pharmaceutical grade medicines in tablet, capsule, injectable, or topical forms. These bulk pharmaceuticals are produced from chemical plants from different countries like India and China that represents the largest international supplier of bulk APIs.

APIs brought in bulk form are routinely inspected by the receiving country for its safety profile and efficacy level. For example, China and India suppliers that ships their APIs to the United States gets their shipments meticulously examined by the USFDA before it is licensed for release for public consumption. The European Medicines Agency likewise functions in the same way in regulating incoming bulk pharmaceuticals for the consumption of Europe.

Manufacturers implore the use of standardization techniques in determining the relative strength of an API in each drug, but the standards vary in different medicine brands. The relative strength and the quality of the APIs have a direct effect on its efficacy and safety profiles. Contaminated active ingredients which are poorly processed may result in the serious complications and even death to some recipients. For this very reason, APIs are strictly regulated in most countries worldwide.

API bulk suppliers should conform to the local standards of the regulating body in each country before they are licensed. The Active Pharmaceutical Ingredients quality must be taken into a major consideration before mass production of medicines. Suppliers and Manufacturers must adhere to certain international standards of operation (ISO) in the processing, manufacturing, labeling, packaging, repacking, warehousing, and releasing of APIs for it to be accredited by the regulating agencies of each country.