Active Pharmaceutical Ingredients [APIs] and what they mean in the World of Pharma

By Team Molkem

Only a small amount of the active ingredient has an effect, so only a tiny part of the active ingredient is contained in the medicine. You will always find the name and amount of the active ingredient contained in the medicine on the package of the drugs that you would purchase from your chemist across the counter.

Usually, the manufacturing and production of APIs has traditionally always been carried out by the pharmaceutical companies themselves in their home countries. But in recent years many corporations have opted to send manufacturing overseas to cut costs and spread diversification as well. This has caused significant changes to how API drugs are regulated, with more rigorous guidelines and inspections put into place.

Components of Medications                               

All drugs are made up of only two core components. The more important of the two is the API, which is the central ingredient, and the other is the excipient which are nothing but the substances other than the drug that help deliver the medication to your system. Excipients are chemically inactive substances, such as lactose or mineral oil in the pill.

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. Each brand might use different test methods, that can result in different potencies.

In all cases, manufacturers are required by the FDA to prove the potency of their products in real-life patients, as well as in laboratory conditions.

Difference between APIs and Raw Material

API and raw material are often confused due to the similar usage of the two terms. What is the difference? Raw material refers to chemical compounds that are used as a base to make an API. These are purchased from raw material or chemical product manufacturers internationally from across the globe depending on availability, logistical conveniences and of course cost and pricing as well.

When using the raw materials, as an API manufacturer one has to produce API in large quantities in reactors in in factory plants. The API is not made by only one reaction from the raw materials but rather it becomes an API via several chemical compounds which is what makes it so potent and hence requires only small doses in your medicines.

The chemical compound which is in the process of becoming an API from a raw material is called an intermediate. Among the APIs that are produced, there is an API which passes through over ten kinds of intermediates in a process when it changes from being a raw material into an API. After this long manufacturing process, it is purified until it reaches a very high degree of purity and finally becomes an API.

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Where APIs Are Made

While many active pharmaceutical ingredients manufacturers and pharmaceutical companies are located in the United States and England, it would be safe to say that the very the largest API manufacturers are located in Asia, particularly in India and China.

Due to the global pandemic, more and more companies are outsourcing to cut costs on expensive equipment, employees, and infrastructure which is why labour-intensive countries like India and China are benefitting in the API and other pharma sectors. While this has helped their bottom line, there is continued concern about the quality of these APIs produced overseas.

It would be interesting to note that AstraZeneca Pharmaceuticals used to operate several manufacturing centres in the United States before the pandemic struck. However, now, only 15% of their APIs are created in America while there are advanced talks and plans to bring to an end even that very small percentage in favour of distributing and outsourcing all their other manufacturing overseas.

Regulations

The quality of APIs has a significant effect on the efficacy (producing the result desired) and the safety of medications. Poorly manufactured or compromised APIs have been connected to serious issues, such as illnesses or 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. One company used to create the API, build the capsule, and package the medicine—but no longer.

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

Through this piece it is now easy to understand that the medicines that we take often and sometimes for granted are in fact complex scientific processes which have cumulated into effective remedies against ailments and illnesses after possibly years of though research and several rounds of continuous development. But having even a cursory idea about how APIs work, you also have a better idea about the medicines that are being prescribed to you and how they will work against different illnesses.