2025-01-14
What is an 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.