Recipharm expands manufacturing to meet demanding FDA requirements

Sweden-headquartered contract development and manufacturing organization (CDMO) Recipharm has developed a new, dedicated manufacturing facility to meet the latest regulatory expectations for non-bacterial beta-lactam medicines. This investment responds to regulatory guidance and to growing customer demand for compliant, dedicated manufacturing solutions.

The final draft guidance published by the US Food and Drug Administration (FDA) requires non-bacterial beta-lactam compounds to be manufactured in a manner that fully prevents cross-contamination with other pharmaceutical products. The intent of the guidance is to further enhance patient safety, as even trace exposure to these compounds can trigger allergic reactions in susceptible patients.