Active Pharmaceutical Ingredient or API is the biologically active part of the drug present in different types of medications like tablets, capsules, injectables, creams, etc. In simple words, it refers to those ingredients of a drug that produce the intended results. As active pharmaceutical ingredients are very powerful, a small quantity does the job.
The name and quantity of an API in medication are mentioned on the over-the-counter drug's package. In some cases, the name of the medicine is the active pharmaceutical ingredient used in it. For example, the API of Paracetamol is paracetamol.
Pharma API Full Form
API full form in pharma is Active Pharmaceutical Ingredient. API simply refers to the active ingredients in medicines that produce results. Here is some vital information about APIs in medicine:
- The major components of any medicine are APIs and excipients.
- Excipients are inactive compounds in a drug, like lactose, and help with taste, consistency, color, etc.,
- Excipients facilitate the API to reach the system, meaning that excipients carry out the active pharmaceutical ingredient in medicine.
Top 10 Active Pharmaceutical Ingredient Manufacturers
A large number of firms produce active pharmaceutical ingredients in India. We have given a list of the top 10 API manufacturers in India here. Check out the details regarding the same in the table given below:
Active Pharmaceutical Ingredients Manufacturers in India
Sun Pharmaceutical Industries Ltd.
TAPI (Teva Active Pharmaceutical Ingredients)
Novartis International AG
Merck & Co.Inc.
Dr. Reddy's Laboratories
Types of Active Pharmaceutical Ingredient
Active pharmaceutical ingredients are mainly of two types: synthetic chemical API and natural chemical API. We have provided the details about these two different types of API and their examples below:
- Synthetic Chemical API - These are called small molecules and make up a large part of the commercial pharmaceutical market.
- Natural Chemical API - These are used in the making of biologics. They are also becoming popular in the API pharma market. Yet, small drug molecules remain the major players in the pharmaceutical market.
Active Pharmaceutical Ingredient Example
Active pharmaceutical ingredient can be found in various types of pharma products, such as capsules, tablets, injectables, creams, etc. APIs are the heart and soul of any pharmaceutical drug. Find the example of different types of APIs here:
- Examples of synthetic chemical API - Aspirin, diphenhydramine, etc.
- Examples of Natural Chemical API - Humira, Remicade, Rituxan, etc.
Active Pharmaceutical Ingredient Manufacturing Process
APIs are produced in large production plants. They are not the raw materials of a drug because many complex chemical reactions formulate them. To manufacture an active pharmaceutical ingredient, one has to follow several complicated steps.
Earlier, APIs were produced by pharmaceutical companies in their home countries. But now, their production is conducted overseas in order to reduce the cost of the drug. The steps of manufacturing active pharmaceutical ingredients are:
- Feed Handling: The preparation and transport of required raw materials.
- Reactions: The feed materials are converted into API through chemical reactions. Depending upon the API chemistry, the production can occur by chemical synthesis or biotechnology.
- The chemical process to produce active pharmaceutical ingredients include loop reactors, batch reactors, and specialized batch autoclaves. Biological processes imitate reactions that occur in living organisms. The major biotechnology used in the production of API is fermentation.
- Recovery: After the reactions, the product released contains APIs and other by-products. Many recovery methods are adopted to separate the active pharmaceutical ingredients, including distillation, membranes, filtration, crystallization, etc.
Active Pharmaceutical Ingredients - Regulation and Inspection
Active pharmaceutical ingredient is responsible for achieving the desired goals of a drug in the body. Any mistake can be detrimental to the life of the consumer. It is very important to control and assure the quality of APIs before making the medicines available to the common public. Here are some rules and regulations regarding API in pharmacy:
- No matter where these ingredients are produced, the companies are bound to follow strict safety and quality control protocols.
- The active pharmaceutical ingredients produced in China and India for the US market must be regulated and licensed by the FDA.
- If the end consumer of the active pharmaceutical ingredient is Europe, they must adhere to the regulations of the European Medicines Agency.
Due to the increase in chronic diseases and an aging population, the active pharmaceutical ingredient market is only on the rise. Effective APIs indicate a step towards better health care, and the ever-growing demand for pharmaceuticals in the pandemic-prone, health-conscious world gesture a great growth of opportunities in the commercial market.
FAQs on Active Pharmaceutical Ingredients
Q.1. What is active pharmaceutical ingredient?
An active pharmaceutical ingredient is an active substance in a pharmaceutical drug that is responsible for the desired health results. API is carried into the medicine through excipients, which are a type of inactive compound.
Q2. What is pharma API full form?
API full form is active pharmaceutical ingredient. API is an active compound found in medicines. It simply refers to the active ingredients in medicines that produce results. APIs are carried by excipients into the medicine.
Q.3. Which are the top active pharmaceutical ingredient manufacturers in the world?
The top active pharmaceutical ingredients manufacturers in the world include Pfizer Inc., Novartis International AG, Sanofi, Boehringer Ingelheim, and Bristol-Myers Squibb.
Q.4. Who is the largest producer of active pharmaceutical ingredients?
China is the largest producer of active pharmaceutical ingredients in the world, contributing to 44% of the total global API production. The second-largest producer of API in pharmacy is India, contributing to 20% global production of API active pharmaceutical ingredient.