Active pharmaceutical ingredients or APIs can be defined as the chemicals used to manufacture pharmaceutical drugs. The active ingredient (AI) is the substance or substances that are biologically active within the drug and is the specific component responsible for the desired effect it has on the individual taking it.

Any drug or medication is composed of two components. The first is the API processing equipment – which is the central ingredient. The second is known as the excipient, which is the inactive substance that serves as the vehicle for the API itself. If the drug is in a syrup form, then the excipient is the liquid that has been used to make it as such.

APIs are generally manufactured through a variety of processes that include:

Chemical synthesis

Fermentation processes

Recombinant DNA

Isolation and recovery from natural sources

A combination of these processes

The purpose of API production according to the FDA is to cause ‘pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the human body.

There are however certain APIs that are unknown and so require additional substances that work in conjunction with the API to produce the required effect. This is very visible in herbal medicines in which the API is frequently a combination of several mixtures and/or substances which when used together cause pharmacological activity on the body. In these situations, the API is not a single substance but the culmination of various ingredients.

By drawing these distinctions between APIs and the drugs themselves, manufacturers are able to specialize and pharmacists able to align generic equivalents with brand names. This is of vital important and underlies one of the most solid principles and regulations of modern pharmacy.

The Active Pharmaceutical Ingredient Industry is the organ by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physical means. Depending on the complexity of the molecule required, synthesis of APIs might need multi-step complex chemistry utilizing a range of processing technologies.

The leading manufacturer of APIs Jinzong Machinery specializing in range of API-related fields, TAPI works in areas such as chemical synthesis, fermentation, chromatography and plant extraction.  

The current growth in new medical technologies is spurring the demand for APIs worldwide today especially with the increased importation of raw pharmaceutical ingredients from emerging markets.