Active Pharmaceutical Ingredient

The Active Pharmaceutical Ingredient (API) is the part of any drug that produces its effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways.

Production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries. But in recent years many corporations have opted to send manufacturing overseas to cut costs.


Active pharmaceutical ingredient (API), is the term used to refer to the biologically active component of a drug product (e.g. tablet, capsule). Drug products are usually composed of several components. The aforementioned API is the primary ingredient. Other ingredients are commonly known as "excipients" and these substances are always required to be biologically safe, often making up a variable fraction of the drug product. The procedure for optimizing and compositing this mixture of components used in the drug is known as "formulation."

For example, if the API is a solid and the drug is required to have a liquid dosage form, such as a cough syrup, then the excipients would be the liquids that are used to formulate the syrup. The design criteria for any small molecule API is usually a combination of several factors that go beyond the intended therapeutic effect, and usually heavily encompasses both pharmacokinetic and pharmacodynamic considerations, so for this reason, API molecules have many chemical functional groups.

The API form that is used in a formulation is often the most thermodynamically stable crystalline form. As such, the phenomenon of hydrogen bonding in combination with there being many functional groups on the API usually results in the available crystalline form being a hydrate.

Because of this fact, the hydration behavior of crystalline APIs is of particularly high importance within the pharmaceutical industry and is vastly studied from every possible angle. The state of hydration has a direct effect on the physical properties of the API, which in turn has a large impact on the drug processability and how the drug will eventually perform in-vivo, i.e. stability, solubility, and bioavailability. This has caused significant changes to how these drugs are regulated, with more rigorous guidelines and inspections put into place. 

Components of Medications

All drugs are made up of two core components: the API, which is the central ingredient, and the excipients, the substances other than the drug that helps deliver the medication to your system. Excipients are chemically inactive substances, such as lactose or mineral oil. 

For instance, if you have a headache, acetaminophen is the active ingredient, while the liquid in the gel-capsule or the bulk of a pill is the excipient.

Strength of APIs

Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand to another. One brand might use one test, another a different one. In all cases, manufacturers are required by the FDA to prove the potency of their products in real life patients, as well as laboratory conditions.

Top API Manufacturers

The largest are located in Asia, particularly in India and China. More and more companies are turning to outsourcing to API manufacturers like Dr. Reddy's to cut costs on expensive equipment, employees, and infrastructure. 

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

Regulations

The quality of APIs has a significant effect on the efficacy and safety of medications. Poorly manufactured or compromised APIs have been connected to serious issues, such as illnesses and even death.

Even in the case of outsourcing, APIs are subject to stringent regulations and oversight from the country they are shipped to. For example, API manufacturing plants overseas still go through an inspection by the U.S. Food & Drug Administration.

As evidenced by the creation of APIs, the pharmaceutical industry is rapidly changing. Companies no longer handle every step of the drug-making process, from creating the API to building the capsule. In order to cut down on expenses and increase profits, companies have begun outsourcing the creation of APIs to foreign manufacturers based in Asia.

While this has helped their bottom line, there is continued concern about the quality of these APIs produced overseas.

In response, governing bodies responsible for patient safety, such as the FDA, have instituted intense screenings to ensure medication quality and prevent defects. Violating any of these established standards can result in fines or very expensive recalls for the pharmaceutical companies behind these manufacturers. 

This has caused significant changes to how these drugs are regulated, with more rigorous guidelines and inspections put into place. 

Components of Medications

All drugs are made up of two core components: the API, which is the central ingredient, and the excipients, the substances other than the drug that helps deliver the medication to your system. Excipients are chemically inactive substances, such as lactose or mineral oil. 

For instance, if you have a headache, acetaminophen is the active ingredient, while the liquid in the gel-capsule or the bulk of a pill is the excipient.

Strength of APIs

Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand to another. One brand might use one test, another a different one. In all cases, manufacturers are required by the FDA to prove the potency of their products in real life patients, as well as laboratory conditions.

Top API Manufacturers

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. 

Where are APIs Made?

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 turning to outsourcing to API manufacturers like Dr. Reddy's to cut costs on expensive equipment, employees, and infrastructure. 

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

Regulations

The quality of APIs has a significant effect on the efficacy and safety of medications. Poorly manufactured or compromised APIs have been connected to serious issues, such as illnesses and even death.

Even in the case of outsourcing, APIs are subject to stringent regulations and oversight from the country they are shipped to. For example, API manufacturing plants overseas still go through an inspection by the U.S. Food & Drug Administration.

As evidenced by the creation of APIs, the pharmaceutical industry is rapidly changing. Companies no longer handle every step of the drug-making process, from creating the API to building the capsule. In order to cut down on expenses and increase profits, companies have begun outsourcing the creation of APIs to foreign manufacturers based in Asia.

While this has helped their bottom line, there is continued concern about the quality of these APIs produced overseas.

In response, governing bodies responsible for patient safety, such as the FDA, have instituted intense screenings to ensure medication quality and prevent defects. Violating any of these established standards can result in fines or very expensive recalls for the pharmaceutical companies behind these manufacturers.