An active pharmaceutical ingredient (API) is any substance or mixture of substances used in a finished drug product to achieve a pharmacological effect. Custom API development refers to manufacturing the required quantity of APIs only at a specific scale according to the customer’s requirements.
The development and manufacturing of active ingredients is the foundation upon which pharmaceuticals are built. Companies can use either traditional or advanced approaches to drug substance development, or a combination of both. The quantities produced by API synthesis are typically small, ranging from a few milligrams to about 10 kilograms, and this can be done in-house or by the manufacturer. Custom development is very important to the pharmaceutical industry because many active pharmaceutical ingredients (APIs) can be very difficult to find or difficult to synthesize. Custom synthesis provides customers with a platform to accelerate time-to-market for final dosage forms (FDFs).