APIs (Active Pharmaceutical Ingredients) are the chemicals used in manufacturing pharmaceutical drugs. The APIs are biologically present in the drug and are responsible for the effects that a drug produces. Any drug is made up of two components – API (which is the main ingredient) and excipient. The excipient is the inactive substance of the drug and acts as a carrier of the API. For example, in a paracetamol tablet, paracetamol is the API and the binding agent (say, starch) is the excipient.
Processes for manufacturing of APIs
- Chemical synthesis
- Fermentation processes
- Recombinant DNA
- Isolation and recovery from natural sources
- A combination of these processes
According to the Food and Drugs Administration (FDA), the purpose of API is to root pharmacological activity or other direct effects for diagnosis, cure, mitigation, treatment or prevention of disease in humans. Even though APIs are the main ingredients of any drug, some of them are still unknown. To bring the required effects, these unknown APIs are mixed with additional substances for conjecture. Before releasing the drug in the market, manufacturers are required to demonstrate the safety of the APIs in real as well as laboratory conditions.
Regulation Related to API
The safety and efficacy of a drug depend on the quality of its API. Poorly manufactured or unsafe APIs may result in harmful consequences, including death. Therefore, they are required to be regulated. APIs must adhere to strict safety and quality standards set by the manufacturing country. Even if the manufacturing is outsourced, APIs must follow the stringent rules of the concerned health authority. For example, if the API is manufactured in Korea or Japan for distribution in the US, it will still be inspected under the FDA guidelines.
As the regulations are evolving, keeping abreast with API Regulatory standards is a requisite for manufacturers. For bespoke information and Regulatory support regarding the API regulations, connect with our Regulatory Affairs experts. Reach us at email@example.com.