What is API? What is its function?
In our daily life, the tablets, capsules, injections, oral liquids, etc. taken when we are sick are all finished drugs. However, the ingredients that really play a therapeutic role in these drugs are not the tablet shell or liquid form we see, but the "API" hidden in it - Active Pharmaceutical Ingredient, referred to as API. It is called the "heart" of the drug and the source of all drug effects.
So, **What is API? What role does it play in the pharmaceutical industry? Why should ordinary people pay attention to this concept that seems far away from us? **This article will unveil the mystery of API for you.
1. What is API?
API refers to the active ingredient used in drug preparations, that is, the chemical or biological component that plays a role in preventing, diagnosing, and treating diseases in drugs. It does not include the excipients required to make drugs (such as starch, lactose, stabilizers, etc.), but the "core" of the drug that is truly pharmacologically active.
For example:
Acetylsalicylic acid in aspirin tablets is its API.
Cold medicine compound preparations may contain a variety of APIs, such as acetaminophen (antipyretic), pseudoephedrine (decongestant), chlorpheniramine (antiallergic), etc.
Therefore, APIs are not finished drugs, but the original and basic active ingredients for producing drugs. They are intermediate products in the pharmaceutical process, but they are the source of the entire drug efficacy.
2. What types of APIs are there?
Pharmaceutical APIs can be divided into the following categories according to their sources and production methods:
1. Chemical synthesis APIs
Made through organic or inorganic chemical reactions, such as ibuprofen, penicillin V potassium, cephalexin, etc. This type is currently the largest and most widely used type.
2. Fermentation APIs
Produced through microbial fermentation, commonly used in antibiotics and vitamin products. Such as erythromycin, vitamin B12, penicillin, etc.
3. Biotechnology APIs
Using bioengineering technology, such as recombinant DNA technology, cell culture, enzyme catalysis and other production methods, common in the field of biopharmaceuticals. Such as recombinant human insulin, interferon, monoclonal antibodies, etc.
4. Natural extract APIs
Extracted from plants, animals or minerals, such as artemisinin, ginsenosides, atropine, etc., they are often used in the production of Chinese patent medicines or natural medicines.
3. What is the role of pharmaceutical APIs?
1. The core component of treating diseases
No matter what form of medicine, the API is the one that really plays a role. For example, the API of a drug for treating hypertension may be amlodipine; the API of a drug for treating infection may be cefotaxime.
2. Basic substances for drug research and development
The first step in the development of new drugs is often to synthesize APIs from structural design and test their activity, toxicity and metabolic processes. The first thing to test in the clinical trial of a new drug is the safety and efficacy of APIs.
3. The key part of cost composition
In many drugs, APIs account for 50%-80% of the total cost. Therefore, the cost of API directly affects the market price and accessibility of the entire drug.
4. Impact on the stability of drug supply
Once a certain API supply chain is interrupted, it will affect the production of related finished drugs. During the COVID-19 pandemic in 2020, the global pharmaceutical supply chain was impacted because several key API production sites (such as China and India) were restricted, resulting in drug shortages.
4. How strict is the production and quality control of API?
Since API is directly related to the quality and safety of drugs, extremely strict international standards must be followed in production and supervision.
1. GMP standard requirements
GMP (Good Manufacturing Practice) has strict regulations on API production processes, clean environments, personnel operations, and testing processes. Any error in the production process of any batch of API may affect the safety of the entire finished drug.
2. Pharmacopoeia standards
API needs to meet the requirements of national pharmacopoeias (such as the Chinese Pharmacopoeia, the United States Pharmacopoeia USP, and the European Pharmacopoeia EP) for purity, impurities, stability, etc.
3. International registration
Many Chinese API companies' products need to be registered and certified by international organizations such as the US FDA and the EU EDQM before they can be exported and used by large international pharmaceutical companies.
5. APIs are not intermediates and cannot be taken directly.
Many people mistakenly believe that APIs can be taken directly like finished drugs. This is a serious misunderstanding and may even endanger life.
The reasons are as follows:
APIs are usually high-purity chemicals that have not been dosed. Overdose can cause poisoning;
It lacks excipients for sustained release or gastrointestinal protection, and direct consumption can irritate the gastrointestinal tract;
APIs have not been packaged, indications and dosage instructions are not marked, and they do not meet drug use standards.
In addition, some illegal organizations sell so-called "API weight loss pills" and "antidepressant raw powders", which are illegal and pose extremely high health risks.
6. Why is China called the "world API factory"?
After decades of development, China has become one of the world's largest API producers and exporters. Data shows that:
China's API exports account for more than 60% of the global market;
Covering multiple categories such as antibiotics, antipyretics, analgesics, vitamins, cardiovascular and cerebrovascular drugs;
It has significant advantages in cost control and production capacity scale.
But at the same time, it also faces some challenges:
High environmental pressure: API production usually involves high pollution and high energy consumption processes;
Technical threshold bottleneck: high-end API and biological drug raw materials are still dominated by European and American companies;
International trade friction: Chinese companies need to face anti-dumping barriers and policy restrictions from India, Europe and the United States;
Insufficient upstream extension capabilities: many companies are still in the "OEM" position and do not have core patents and new molecule development capabilities.
VII. Future development trend of API industry
Green production and clean processes will become the mainstream
The future API industry needs to adopt a low-emission, low-pollution green manufacturing model under the guidance of the "carbon peak and carbon neutrality" policy.
Integrated layout will improve corporate competitiveness
Pharmaceutical companies that integrate preparations + APIs will have more bargaining power and stability. For example, Shijiazhuang Pharmaceutical Group and Hengrui Medicine are already actively deploying.
API is transforming towards high-end and biological
The rise of new targeted drugs, anti-tumor drugs, and biosimilars has put forward higher requirements on the complexity of API structure and the difficulty of synthesis.
International registration is accelerating
More and more Chinese API companies are applying for CEP certificates and FDA certifications to enter the high-end markets in Europe and the United States, pursuing both quality and brand improvement.
VIII. Conclusion: API is "invisible", but it is crucial
Although we see a variety of finished drugs in hospitals and pharmacies, what really makes these drugs "work" is the invisible API - API.
API determines whether a pill is effective, safe, and controllable; it affects the price, accessibility, and supply chain stability of the drug. Understanding the role of API is not only a compulsory course for pharmaceutical practitioners, but also a key step for the public to improve their health literacy.
In the future, as the global pharmaceutical market continues to increase its requirements for quality, environmental protection, and innovation, the API industry will not only be a basic manufacturing industry, but also the core support force of the entire pharmaceutical innovation chain.
