Active Pharmaceutical Ingredient

Active Pharmaceutical Ingredient

What Is an Active Pharmaceutical Ingredient (API)?

Active Pharmaceutical Ingredient (API) is the biologically active component of a drug product (tablet, capsule, cream, injectable) that produces the intended effects.

They are in a variety of states, such as crystals and powders. It has pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, or prevention of disease, or it can affect the function or structure of the body. 

The main feature of the API is that it cannot be directly used for clinical use. It is a raw material and can only be used as a pharmaceutical preparation after processing, and then can be used as a medicine for clinical application according to experiments.

Top Manufacturing Companies

A leading manufacturer of APIs is TEVA Pharmaceuticals. With over 300 API products, they have the industry's largest portfolio. Another leading manufacturer is Dr. Reddy's, with more than 60 APIs in use today.

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.

Top Manufacturing Countries

While many pharmaceutical companies are located in the United States and England, most API manufacturers are overseas. The largest are located in Asia, particularly in India and China.

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

Notably, AstraZeneca Pharmaceuticals used to operate several manufacturing centers in the United States. Now, just 15% of their APIs are created in the U.S. and there are plans to end that small percentage and outsource all manufacturing overseas.