What are Active Pharmaceutical Ingredients?
There are various elements or components involved in a drug that are vital to produce a desired health effect are called active pharmaceutical ingredients. For example, acetaminophen is an active pharmaceutical Ingredient in Tylenol. Knowledge of APIs helps differentiate between generic drugs and its brand name versions. It requires a mix of multiple application chemical compounds to process an API.
Definition of Active Pharmaceutical Ingredients
The main ingredient contained in a medicine that is required to provide a desired effect is called API. There are stringent laws and regulations to be followed to manufacture and introduce any drug into the market. This is necessary to maintain quality, consistency and minimize the risk of contamination.
Any medicine or drug consists of 2 main components:
- 1. Active pharmaceutical Ingredient (central ingredient).
- 2. Excipient (any substances other than the drug, which are chemically inactive).
Different Types of Active Pharmaceutical Ingredients
APIs are segmented into 2 categories:
- 1. Synthetic Chemical APIs: Known as small molecules but are a major part of the global commercial pharma market.
- 2. Natural Chemical APIs: Mainly used in biologics, these are making slow but steady inroads into the global pharma market and gaining popularity.
Active Pharmaceutical Ingredients – Strength & Intermediates
Active pharmaceutical ingredient companies in India and the rest of the world need to follow strict FDA rules, specifications and standardizations to measure the amount of API in every drug. The amount may vary according to product and testing techniques to maintain effectiveness. The FDA law requires every drugs’ effectiveness to be demonstrated to the fullest before approving it to be used by patients.
How are APIs produced?
Traditionally, APIs were produced by pharma companies in their home countries, but now companies have started outsourcing the production to other countries with the aim of cost cutting and maintaining quality.
Depending on their chemistry and chemical reactions, certain raw materials are converted into API. This process involves loop & batch reactors, and various recovery methods such as distillation, membranes, filtration, and crystallization. Every process requires strict quality control checks, regulations and compliance.
API manufacturing companies in India and China are witnessing a huge demand and have got the capacity to provide bulk APIs all over the world. Currently, China is the biggest producer of APIs and India is the second largest producer of APIs.
The most important role of API is to achieve the desired effect of a drug on the patient’s body. Any kind of failure to achieve that can be detrimental to the patient’s health, so efficacy and quality needs to be maintained.
Unhealthy lifestyle and eating habits, ageing population and many other factors have led to an increase in chronic diseases. Post-pandemic era has seen a sudden rise of health-consciousness in certain populations. Both these factors have created a huge growth of opportunities for pharmaceutical companies.
However, concern for quality of API remains, so pharma API manufacturing companies need to continuously innovate & improvise to provide effective & quality drugs to improve lives globally.