API stands for Active Pharmaceutical Ingredient. API is a chemical compound and the most important raw material to produce a finished medicine. API gives the intended effect in the medicine to cure the disease. For instance, Paracetamol is an API for the medicine Crocin and this API is responsible for giving relief from body ache and fever. Every medicine is formed from two main ingredients, the chemically active APIs and chemically inactive, excipients, which is a substance that delivers the effect of APIs to one’s system. In short, API + EXCIPIENTS = PHARMACEUTICAL FORMULATION. It must be noted that excipients have no pharmacological action on their own i.e. they are inert.
Excipients are the bulking agents, fillers, or diluents because in most cases API is in milligrams or micrograms. With the small quantity of APIs, it is impossible to make any stable formulation without adding any excipients. One can find the name and amount of the active ingredient contained in the medicine on the package of OTC (over the counter) drugs. Some medicines also use multiple APIs which are known as fixed-dose combination drugs.
Where APIs are made?
Traditionally, the APIs were produced by the pharmaceutical companies themselves in their own countries but in recent years, many pharma companies have opted to outsource overseas to cut costs on expensive equipment, employees, and infrastructure. This changing trend has caused significant changes in how these drugs are regulated, rigorous guidelines, and more inspections. Pharmaceutical companies are mostly located in the United States and England but the concentration of API manufacturers is high overseas especially in Asia, particularly in India and China.
Who makes APIs and how are they made?
The API manufacturers make API. Their development department conducts a series of experiments to find a chemical compound that has the potential to become an API. After finding the compound, the API manufacturers prepare a chemical compound that becomes an API in the laboratory by considering the degree of concentration and temperature that will help in the development of a quality API. The API is not the result of only one reaction from the raw materials instead it becomes an API after several chemical compounds. A chemical compound which is in the process of becoming an API from raw materials is named as an intermediate. Then the production department manufactures a high quantity of APIs using the large reactors. According to Kastura Chemical, ‘’ If an API is not ultra-pure, medicine can not meet the strict quality criteria. So, the quality of an API plays a really important role”. After that, the quality control staff then conducts analyses in the testing laboratory to examine whether the manufactured API is ultrapure, and after testing it is packaged and becomes ready for sale to the drug manufacturers. Drug manufacturers then make medicines by mixing APIs and pharmaceutical excipients. After this long process, the APIs turn into medicines which are then delivered to hospitals and pharmacies.
What are the regulations?
Regardless of where the API is made, it is the responsibility of the company to adhere to strict safety and quality standards set by the country where it will be used. For instance, the APIs manufactured in China or India for use in the United States must still be inspected and licensed by the FDA. Similarly, if the API is intended for use in Europe, they are required to meet the regulations set by the European Medicines Agency.
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