APIs are substances used in the formulation of medicines that exert the desired pharmacological effect. These ingredients are often produced through complex chemical processes, which require precision and stringent quality control measures. The production of APIs begins with raw materials, which can be either natural substances or synthesized compounds. The choice of raw materials is crucial, as impurities or inconsistencies can lead to ineffective or unsafe medications.
Each category of API has its own regulatory challenges and manufacturing processes. Chemical APIs often face stringent quality control standards due to the risks of impurities and synthesis byproducts. In contrast, biological APIs must adhere to rigorous guidelines surrounding the management of biological materials, including cell lines and fermentation processes.