Active pharmaceutical ingredient (API) is a substance or combination of substances that are used in a finished pharmaceutical product (FPP). They are added to the pharma products to furnish therapeutic activity or directly affect the diagnosis, treatment, cure and prevention of disease. API in Pharma is used in various forms like crystals or powdered, but these cannot be used directly for clinical use. These are the raw material used in the manufacturing of drugs product (capsules, tablets, creams, injections).
APIs- The primary element of medicines
Every drug comprises two core elements – API and excipient. API is the major ingredient in the medicine that works in your body, whereas the excipient provides a sweet flavour, colour, or volume to the pill. For example, in aspirin, the API is “acetylsalicylic acid”, which helps cure your fever or headache. Excipients are only supposed to deliver the medicine to the body. Unlike API, these are chemically inactive compounds like mineral oil or lactose in the pill.
APIs are majorly classified into two different types:
Chemical synthetic drugs
It is a type of API which is further classified into organic and inorganic synthetic drugs. Synthetic inorganic medicines are composed of inorganic compounds and very few elements. Magnesium trisilicate and aluminium hydroxide, which are widely used in the treatment of duodenal ulcers and gastric ulcers are two examples of inorganic drugs. On the other hand, synthetic organic medicines mainly constitute organic chemicals as raw materials that are formulated by a series of chemical reactions. Aspirin, caffeine, chloramphenicol, etc., are some of the examples of organic synthetic drugs.
Natural chemical drugs
Natural chemical drugs are compounds derived from nature. These are further divided into phytochemical drugs and biochemical drugs.
Drugs obtained through biological processes are referred to as biochemical drugs. The most popular example of this type of APIs is Antibiotics that are obtained by the process of fermentation of microorganisms. The APIs falling in the list of phytochemical drugs exist naturally in plants. Paclitaxel (taxol) is a typical example of phytochemical APIs.
Among the APIs, the drug that accounts for the largest proportion of variety and output is organic synthetic drugs. These are the essential pillars of the chemical and pharmaceutical industry.
No matter where you have obtained an API, it is required to meet the safety and quality criteria prescribed by the government or industry. This means the drugs sold in a particular country need to meet pharmaceutical industries’ strict safety and quality standards. The quality of the API you are obtaining has a significant effect on medications’ efficacy and safety. Poorly manufactured APIs can cause serious health issues. For this reason, API producing companies are inspected by their local government, and the foreign government can also scrutinize them.
When everything is satisfying the set standards, companies are given certificates so that pharmaceutical buyers know that a specific company complies with the industry standards without inspecting themselves. However, when the company fails to make it through the inspection process, the companies are given a warning, and buyers will not buy APIs from them until the company is re-inspected.
API in Pharma holds great significance. Just like every other industry is changing fast, the pharmaceutical industry is no different. Thanks to the latest technological advancements. Earlier pharma companies used to manage the production of APIs themselves. Still, since adhering to the set rules and regulations is tedious, now they prefer to outsource the production process APIs. This has ultimately made a big difference in their bottom line.