OSD

With more pharmaceutical companies choosing to outsource the development and manufacture of small molecule active pharmaceutical ingredients (APIs), the demand for API contract manufacturing organisations (CMOs) has significantly grown.

Due to the variety of new compounds entering the pipeline, API CMOs need to provide diverse services and flexibility, while also possessing specialist skills.

The two main reasons for outsourcing small molecule API production include lack of internal capability or capacity constraints. In addition, while demand for more complex APIs increases, there are challenging regulatory changes that are impacting API manufacture and creating the need for experienced partners.

Gianluca Franguelli, Vice President of drug substance development, at Recipharm spoke to PharmSource about the key factors influencing pharma companies to outsource the development and manufacture of small molecule APIs and the capabilities that will make CMOs competitive. He also outlines the upcoming regulatory changes that are affecting the industry.