The global pharmaceutical industry is an essential and highly regulated sector that focuses on developing, producing, and distributing drugs to improve health outcomes. A critical component of this industry is the supply chain of active pharmaceutical ingredients (API) and intermediates.
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What is API Meaning in Pharma?
Active Pharmaceutical Ingredients (API) are the chemically active substances in a drug that is responsible for producing the intended therapeutic effect. These ingredients are the core components of medications, which interact with the body’s physiological systems to treat, cure, or alleviate the symptoms of a disease or medical condition.
API is typically combined with other components, known as excipients, which help deliver the active ingredient to the targeted site in the body, stabilize the formulation, and improve its taste, appearance, or shelf life. The combination of APIs and excipients results in the final drug product, such as tablets, capsules, injections, or topical solutions. It is the primary ingredient in a medication that produces the desired effects in treating a specific condition or illness. API manufacturers must adhere to strict regulations and guidelines when producing APIs to ensure they meet the required standards.
Types of Active Pharmaceutical Ingredients (API)
Active pharmaceutical ingredients are regulated by regulatory bodies such as the FDA, and their production is a crucial step in the pharmaceutical industry. API is segmented into biotech and chemical synthesis types based on production methods.
Biotech APIs, or biopharmaceuticals, are produced using biotechnology, which usually involves the manipulation of microbes or other biological substances. Biotech type is further classified into antibodies, recombinant proteins, vaccines, and gene therapies. They are derived from living organisms and are more complex than chemical APIs. And they are typically used in innovative therapies like targeted cancer treatments or autoimmune disease management. Examples of biotech APIs include Insulin for diabetes management, and Trastuzumab, a monoclonal antibody used in cancer treatment.
Synthetic / Chemical Type
Chemical APIs are usually synthesized through chemical processes known as synthetic types of molecules. They form the backbone of traditional drugs and are produced in large quantities by pharmaceutical companies. The synthesis of chemical APIs involves intricate processes that convert raw materials into the desired chemical compounds. The process is strictly controlled to ensure the quality of the final product. Examples of chemical APIs include Acetaminophen, used for pain relief and reducing fever, and Atorvastatin, used to lower cholesterol levels.
Currently, synthetic API dominates the overall market, with a revenue share of about 70%, owing to the higher availability of raw materials and simpler protocols for synthesizing these molecules. Biotech API is expected to become blooming because of the increasing demand for biopharmaceuticals.
Active Pharmaceutical Ingredients (API) List
The API list refers to a list of the specific biologically active components of a finished drug product. It’s important to note that active pharmaceutical ingredients s are regulated by drug regulatory authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These agencies ensure that APIs in drugs are safe and effective. The list of APIs in a particular drug can usually be found in the drug’s package insert or labelling. If you’re looking for a comprehensive list of APIs in all approved drugs, databases like the FDA’s Label Search or the World Health Organization’s International Pharmacopoeia can be useful resources.
For instance, in a painkiller like ibuprofen, the API is ibuprofen itself. In a drug like metformin (used for managing type 2 diabetes), the API is metformin. In many cases, a drug will have just one API, but some drugs may have more than one. In combination drugs, there are multiple APIs. For example, in a combination pill used for HIV treatment, there may be three different APIs.
APIs are different from “excipients,” which are all the other substances present in a drug product. Excipients serve various purposes, such as helping to deliver the API to the appropriate site in the body or improving taste or appearance, but they do not have therapeutic effects.
Manufacturing Process of Active Pharmaceutical Ingredients
The manufacturing process of active pharmaceutical ingredients (APIs) is a complex, multi-step process that can be broadly divided into the following stages:
Discovery and Development
This is the initial stage where the potential API is identified, and its therapeutic potential is evaluated. This stage involves extensive research and laboratory testing.
Once the API is identified, scale-up studies are conducted. In this phase, the process developed in the lab is adapted for large-scale manufacturing. This involves scaling up the reactions and ensuring they can be carried out safely and efficiently on a larger scale.
This is a critical stage where the process is optimized to increase yield rate, reduce waste, improve safety, and decrease costs. This often involves adjusting reaction conditions such as temperature, pressure, and pH or exploring different catalysts or solvents.
The API is produced on a large scale using the optimized process. This can involve a series of chemical reactions, separations, and purifications.
After production, the API needs to be purified. This involves removing any by-products or impurities from the reaction. Common purification methods include crystallization, chromatography, and filtration.
The purified API is then dried to remove any residual solvents or moisture. Common drying techniques include tray drying, spray drying, and lyophilization (freeze drying).
The API is subjected to rigorous quality control testing to ensure it meets all necessary standards for purity, potency, and safety. This may involve testing for specific impurities, verifying the API’s structure, and confirming its therapeutic activity.
Finally, the API is packaged and stored under conditions that maintain its stability until it’s ready to be formulated into a drug product.
Throughout the manufacturing process, Good Manufacturing Practices (GMP) are followed to ensure the quality of the API. In many countries, manufacturing facilities are also inspected by regulatory authorities to ensure compliance with GMP.
Top Active Pharmaceutical Ingredient Manufacturers
Manufacturers play a vital role in the supply chain of active pharmaceutical ingredients. These companies are responsible for producing APIs and intermediates used in pharmaceutical manufacturing. Some of the top manufacturers of APIs and intermediates include companies like Pfizer, Novartis, and Merck. These companies often have their manufacturing facilities spread across various countries to manage the price and availability of APIs and intermediates. The leading manufacturers of active pharmaceutical ingredients (APIs) globally include:
Bristol-Myers Squibb Company
WuXi AppTec (WuXi STA)
Shandong Xinhua Pharmaceutical Group
Zhe Jiang Hua Hai Pharmaceutical
Merck & Co., Inc.
Viatris Inc. (Mylan N.V.)
Teva Pharmaceutical Industries
Sun Pharmaceutical Industries
Dr. Reddy’s Laboratories
Teva Pharmaceutical Industries
Top Active Pharmaceutical Ingredient Suppliers
API suppliers are companies that supply APIs and intermediates to pharmaceutical manufacturers. These companies are critical in ensuring the availability of these materials for drug manufacturing. Suppliers typically source their APIs and intermediates from manufacturers and then sell them to pharmaceutical manufacturers. They are an integral part of the API pharma supply chain and contribute significantly to its smooth functioning. Some of the leading suppliers in the market include:
In addition, Bichain is a leading professional manufacturer and supplier of active pharmaceutical ingredients in China. We can provide all kinds of APIs in terms of your requirements. The pharmaceutical industry is a dynamic and constantly evolving field, and the list of leading active pharmaceutical ingredient (API) suppliers might frequently change.
Supply Chain of Active Pharmaceutical Ingredients
The global supply chain for APIs and intermediates is intricate and multilayered. It involves several stages, including sourcing raw materials, producing intermediates, manufacturing APIs, incorporating APIs into finished dosage forms (FDFs), and distributing these drugs to pharmacies and hospitals.
The supply chain of APIs and intermediates is highly complex, involving various manufacturers, suppliers, and regulatory bodies such as the Food and Drug Administration (FDA). Top API manufacturing companies have dedicated API divisions and employ chemical synthesis and biotechnology to produce APIs. The choice between the two largely depends on the molecule’s complexity and production cost. The companies involved in this supply chain range from multinational pharmaceutical corporations to smaller, specialized manufacturers. Manufacturers source their APIs and intermediates from these companies, often based on factors such as price, quality, and reliability of supply.
Manufacturers, whether generic or innovative drug companies, source their APIs and intermediates from various suppliers worldwide. Many of these suppliers have their manufacturing facilities in Asian countries, which have traditionally been the top API and intermediates manufacturers due to their cost-effectiveness.
Countries like China and India have become significant players in the API market. They have numerous API manufacturing facilities, contributing significantly to the global API supply. This growth is spurred by lower manufacturing costs and a high degree of expertise in chemical synthesis.
The Covid-19 pandemic has significantly impacted the API pharma industry in various ways. It exposed vulnerabilities in the global supply chain of APIs and intermediates, leading to shortages and price fluctuations in the market. The pandemic also highlighted the need for greater supply chain resilience and diversification, prompting companies and governments to reevaluate their sourcing strategies.
The U.S. Food and Drug Administration (FDA) plays a crucial role in this supply chain, overseeing and regulating the production and distribution of pharmaceuticals. The FDA inspects manufacturing facilities to ensure they meet quality standards and guidelines. Moreover, the FDA maintains a list of approved drug ingredients and their suppliers, ensuring that manufacturers use safe and effective ingredients in their drugs.
Active Pharmaceutical Ingredient Price and Market Dynamics
The global market for APIs and intermediates is driven by various factors. These include demand for specific drugs, regulatory policies, manufacturing costs, and the availability of raw materials. The price of APIs and intermediates often fluctuates based on these factors.
In recent years, the trend of increasing prices for APIs and intermediates has raised concerns about the sustainability of the global pharmaceutical supply chain. Increased demand and rising manufacturing costs have resulted in increased prices for APIs and intermediates. This trend has impacted the profitability of pharmaceutical manufacturers and raised questions about the affordability of drugs for patients.
However, various strategies are being explored to manage these price trends. These include efforts to improve manufacturing efficiency, exploring alternative sources of APIs and intermediates, and implementing more effective pricing strategies.
Active Pharmaceutical Ingredient Uses
The primary use of APIs lies in their therapeutic applications. APIs are the engines of all medicines, providing the necessary effects to alleviate, cure or prevent diseases. They can be found in all types of medicinal products, including analgesics, antipyretics, antibiotics, antiseptics, mood stabilizers, and contraceptives.
Uses of Chemical APIs
Acetaminophen: Used in a variety of over-the-counter pain relievers and fever reducers.
Atorvastatin: A statin used to lower cholesterol levels and reduce the risk of heart disease.
Amoxicillin: A widely-used antibiotic for treating bacterial infections.
Ibuprofen: A nonsteroidal anti-inflammatory drug (NSAID) used for pain relief.
Metformin: An oral diabetes medicine that helps control blood sugar levels.
Uses of Biotech APIs
Insulin: A hormone that regulates the amount of glucose in the blood, used in diabetes treatment.
Trastuzumab: A monoclonal antibody used for treating certain types of breast and stomach cancers.
Infliximab: A monoclonal antibody used to treat autoimmune diseases such as rheumatoid arthritis and Crohn’s disease.
Etanercept: A biopharmaceutical that treats autoimmune diseases by inhibiting TNF (tumour necrosis factor).
Hepatitis B Vaccine: Used to prevent Hepatitis B virus infection.
API Use in Vaccines
APIs are also essential in the manufacture of vaccines. The API in a vaccine is the antigen that triggers the immune response. This might be a weakened or dead version of the pathogen (virus or bacteria), a toxin produced by the pathogen, or even a protein or a piece of protein from the pathogen. The body’s immune system recognizes this as a foreign object. It mounts an immune response, thus priming the body to respond more efficiently if it encounters the actual pathogen in the future.
Diagnostic Uses of APIs
Certain APIs are used for diagnostic purposes. For example, radiocontrast agents containing APIs are used in imaging procedures to enhance the visibility of specific structures or fluids within the body. These APIs improve the contrast of images, enabling more accurate diagnoses.
APIs also play a vital role in research and drug discovery. Scientists studying disease mechanisms often use APIs to investigate how these diseases affect physiological processes and how they can be countered. By understanding the interaction of an API with the body at the molecular level, researchers can discover new APIs or develop novel therapeutic strategies.
Now you may have a knowledge of the active pharmaceutical ingredients. When you buy medicine at a pharmacy, you can check the list of ingredients on the medicine package. You will then find the most important active pharmaceutical ingredients you buy.