Recipharm, a global CDMO, has developed a new, dedicated manufacturing facility in support of the latest FDA regulatory guidance for non-bacterial beta-lactam medicines. This investment responds to regulatory guidance and to growing customer demand for compliant, dedicated manufacturing services.

The final draft guidance published by the FDA requires non-bacterial beta-lactam compounds to be manufactured in a manner that fully prevents cross-contamination with other pharmaceutical products. The guidance aims to enhance patient safety, as even trace exposure to these compounds can trigger allergic reactions in susceptible patients.

Recipharm has established a purpose-built, dedicated capability for non-bacterial beta-lactam tablet production to support regulatory expectations, while maintaining flexibility, speed and continuity of supply, according to the company. The facility has been designed to comply with both U.S. FDA and European Medicines Agency regulatory requirements.  

As a result of this investment, Recipharm has secured a major partnership with a biopharmaceutical company to manufacture its non-bacterial beta-lactam tablets. The partnership includes the installation of new, specialized manufacturing capabilities at Recipharm’s site in Bengaluru, India.

This strategic expansion supports the current collaboration and establishes a strong platform with available capacity to serve additional pharmaceutical and biopharmaceutical companies with non-bacterial beta-lactam manufacturing requirements.

Greg Behar, CEO at Recipharm said, “Regulatory change should not become a barrier to innovation or patient access. Our role as a CDMO is to adapt to our customers’ need and how the market is regulated. We evolve our manufacturing capabilities so our partners can focus on what matters the most to them: researching and developing new drugs.”