Active Pharmaceutical Ingredient
The Active Pharmaceutical Ingredient (API) is the part of a drug that begins its effects. Some drugs, such as sequence therapies, have multiple active ingredients to treat various symptoms or act in diverse ways.
Production of APIs has traditionally been done by the pharmaceutical firms themselves in their home countries. But in recent years many companies have opted to send manufacturing overseas to cut costs. This has caused important changes to how these drugs are regulated, with more definite guidelines and inspections put into place.
Components of Medications
All drugs are made up of two essential components: the API, which is the central ingredient, and the excipients, the substances other than the drug that assists deliver the medication to your system. Excipients are chemically dormant substances, such as lactose or mineral oil.
For instance, if you are having a headache, acetaminophen is an active ingredient, while the fluid in the gel-capsule or the bulk of a pill is the excipient.
Strength of APIs
Manufacturers use definite standards to determine how strong the API is in each drug. However, the standard can differ widely from one brand to another. One brand might practice one test, another a distinctive one. In all cases, manufacturers are required by the FDA to demonstrate the strength of their products in real-world patients, as well as laboratory conditions.
Top API Manufacturers
A leading manufacturer of APIs is Oceanic Pharmachem Pvt.Ltd. With over 300 API products, they have the industry's extensive portfolio. Another principle manufacturer is Dr. Reddy's, with more than 60 APIs in use today.
Where Are APIs Made?
While numerous pharmaceutical companies are located in the United States and England, maximum API manufacturers are overseas. The largest are located in Asia, particularly in India and China. More and more companies are shifting to outsourcing to cut expenses on equipment, employees, and infrastructure.
Now, just 15 percent of their APIs are produced in the U.S. and there are plans to end that minute percentage and outsource all manufacturing overseas.
Regulations
The quality of APIs has a notable effect on the efficacy and safety of medications. Poorly manufactured or compromised APIs have been correlated to serious issues, such as illnesses and even death.
Even in the case of outsourcing, APIs are subject to rigorous regulations and oversight from the country they are shipped to. For example, API manufacturing plants overseas still go through an examination by the U.S. Food & Drug Administration.
As evidenced by the creation of APIs, the pharmaceutical industry is rapidly evolving. Companies no longer manage every step of the drug-making process, from creating the API to building the capsule. In order to cut down on costs and increase profits, companies have begun outsourcing the creation of APIs to foreign companies based in Asia. While this has helped their bottom line, there is continued anxiety about the quality of these APIs produced overseas.
In reply, ruling bodies responsible for patient safety, such as the FDA, have instituted strong screenings to assure medication quality and prevent defects. Violating any of these established standards can result in penalties or very expensive recalls for the pharmaceutical companies following these manufacturers.