API
Active pharmaceutical ingredients
Overview
What is API in pharma industry?
Active pharmaceutical ingredients (APIs) are the active components in a pharmaceutical drug that produce the required effect on the body to treat a condition. APIs are produced by processing chemical compounds. In a biologic drug, the active ingredient is known as a bulk process intermediate (BPI).
API
How an API is manufactured?
“API is not made by only one reaction from the raw materials but rather it becomes an API via several chemical compounds. The chemical compound which is in the process of becoming an API from raw material is called an intermediate.”
It further explains that there are some APIs that pass “through over ten kinds of intermediates in a process when it changes from being a raw material into an API”.
The long manufacturing process is continued until it is purified and reaches a very high degree of purity.
An API manufacturer first develops the chemical compound in a laboratory. Later, the production department manufactures high quantity of APIs using large reactors. It is then checked for purity before selling it to drug-makers.
“If an API is not ultra-pure, medicine cannot meet the strict quality criteria. So the quality of an API plays a very important role,
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Who Makes APIs?
First of all, as an API manufacturer we think of how to make a chemical compound which becomes an API in the laboratory. We also have to consider the degree of concentration and which temperature allows a high quality of API to be manufactured efficiently. In order to find answers to these questions, our staff in the development department set about conducting a series of experiments. Once they have decided how to make the compound, our staff in the production department manufacture a high quantity of APIs using the large reactors in our plant. Our quality control staff then conducts analyses in the testing laboratory to examine whether the API manufactured is ultrapure. After testing, our quality assurance staff confirms that everything has been performed correctly in accordance with GMP from manufacturing of API to quality testing. As you can see, a considerable number of staff is involved in the production phase until an API is finally manufactured.
