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API (Active Pharmaceutical Ingredient) #beta #pharma

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What is API (Active Pharmaceutical Ingredient)?

Updated May 27, 2016

The Active Pharmaceutical Ingredient (API) is the part of any drug that is active. Some drugs, such as combination therapies, have multiple active ingredients to treat different diseases. While production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries, in recent years many corporations have opted to send manufacturing overseas to cut costs. 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 excipient, the substance inside the drug that helps deliver the medication to your system. Excipients are inactive substances, such as mineral oil, and not chemically active.

For instance, if you have a headache, acetaminophen is the active ingredient, and the liquid in the capsule 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.

Top API Manufacturers

The 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% 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 medication. 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, any APIs produced overseas for use in drugs produced in America still goes through 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.





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