What exactly is a pharmaceutical API? What is the difference between it and a finished drug?
In our lives, almost everyone has used medicine, but do you really understand the complete process of a drug from raw materials to finished products? Especially the term "API", do you often see it in news and industry reports, but don't know much about it? Today, we will take "API" as the core to fully interpret its concept, classification, function and the essential difference between it and finished drugs.
1. What is a pharmaceutical API?
1. Definition: The "active core" of a drug
API refers to a chemical component with therapeutic effects used to make drugs, that is, the part of the drug that exerts actual pharmacological effects.
Simply put, API is the core ingredient that "works" in a drug. For example, the active ingredient "acetylsalicylic acid" in aspirin tablets is a API, while the shape, color, taste, etc. of the tablets belong to the category of excipients and preparation processes.
2. Not equal to chemical raw materials
It is worth noting that although "API" sounds like "chemical raw materials", there is an essential difference between the two. APIs must meet the purity and quality standards of pharmaceutical grades, and the production process must comply with multiple pharmaceutical regulations such as the Good Manufacturing Practice (GMP).
2. What types of APIs are there?
According to the different sources and production processes, APIs can be roughly divided into the following categories:
1. Chemically synthesized APIs
This is the most widely used type of API, such as ibuprofen, amoxicillin, cephalosporins, etc., which are usually synthesized through chemical reactions.
2. Fermented APIs
Drugs obtained through microbial fermentation technology, such as penicillin, gentamicin, vitamin B12, etc.
3. Biotechnology APIs
Produced by biotechnology such as recombinant DNA technology and cell culture, such as insulin, monoclonal antibodies, vaccines, etc.
4. Naturally extracted APIs
Derived from animals, plants or minerals, extracted by physical or chemical methods, such as Chinese medicine extracts, ginsenosides, artemisinin, etc.
3. What is the difference between finished drugs and APIs?
This is also the most frequently asked question. It can be explained from multiple angles such as composition, function, production links, and regulatory focus.
Dimension API Finished Dosage Form (FDF)
Function Active ingredients that exert their efficacy Drugs with complete dosage forms
Composition Contains only active ingredients API + excipients (such as starch, talc)
Form Powder, crystal, liquid, etc. Tablets, capsules, injections, oral liquids, etc.
Manufacturing is mostly chemical or biological process involving preparation processes, such as tableting, glue filling, etc.
Standards must comply with GMP and pharmacopoeia standards In addition to GMP, consistency evaluation and clinical trials must also be passed
Use intermediate products, not directly for patients, can be directly prescribed by doctors or taken by patients
In short, APIs are "content" and finished drugs are "products". APIs are like engines, and finished drugs are like complete vehicles - what can really "go on the road" is a complete drug after assembly, debugging and packaging.
IV. How important are APIs to the entire pharmaceutical industry?
1. Cost core
In many common drugs, the cost of APIs often accounts for more than 50% of the total cost of finished drugs. Mastering the supply chain of APIs is extremely critical to controlling drug prices.
2. Strategic significance
During the COVID-19 pandemic, the global supply chain was tight, and the dependence of countries such as India on Chinese APIs was exposed. Mastering API production capacity means mastering the initiative in drug pricing and drug safety.
3. Source of innovation
The development of new drugs often starts with molecular structure design. Before they are successfully transformed into drugs, they need to go from experimental APIs to pilot tests and then to large-scale mass production. API companies play an indispensable role in the early development of new drugs.
5. Why do API prices sometimes skyrocket?
Many people will find that the reason why a drug is suddenly out of stock or increases in price is that there is a problem with the supply of APIs. This may be due to the following reasons:
Environmental protection and production restrictions: API production is generally accompanied by pollution and high energy consumption. Once environmental protection policies are tightened, production capacity will be limited.
Rising raw materials: For example, the prices of benzene, alcohol, and acid intermediates have risen sharply, which is transmitted to the cost of APIs.
Monopoly or collusion: The global production capacity of certain categories of APIs is concentrated in a few companies, which is easy to form a price alliance.
Export restrictions/geopolitics: For example, India once restricted the export of APIs, which directly impacted the global market.
Public health emergencies: epidemics, wars, etc. may cause an imbalance in the supply and demand of APIs.
6. What is the current situation of my country's API industry?
China is one of the world's largest API producers, with an output of more than 60% of the global total. With strong chemical synthesis capabilities and cost advantages, it is in a leading position in the field of antibiotics, antipyretics, and vitamins.
But it also faces some challenges:
Biological APIs with high technical barriers still rely on imports;
After the tightening of environmental protection policies, the survival pressure of small and medium-sized enterprises has increased;
Overseas "anti-dumping" barriers have emerged frequently, and export risks have increased;
There is still a gap in GMP certification in line with international standards.
7. Future trends: green, innovative, and international
In the future, the pharmaceutical API industry will develop in the following directions:
Green manufacturing: comply with the "carbon peak and carbon neutrality" policy requirements and reduce the discharge of three wastes.
High-end transformation: transformation from basic raw materials to complex and high-value-added APIs.
International layout: set up factories overseas to reduce the risk of trade barriers.
Integrated integration: Finished drug companies build their own API factories to ensure stable supply.
Digitalization + Automation: Promote intelligent manufacturing to improve production efficiency and safety.
VIII. Conclusion: APIs are the invisible core strength of pharmaceuticals
Although the public is exposed to finished drugs on a daily basis, every pill is inseparable from the support of APIs. It can be said that APIs are the most basic and critical link in the pharmaceutical industry chain.
As the pharmaceutical industry continues to move towards high-quality and sustainable development, APIs are no longer just "behind-the-scenes heroes", but will become an important manifestation of the innovation capabilities and international competitiveness of pharmaceutical companies.
