Recipharm builds beta-lactam tablet facility to meet FDA guidance

Recipharm, a contract development and manufacturing organization (CDMO) headquartered in Stockholm, Sweden, has established a dedicated manufacturing capability for non-bacterial beta-lactam tablet production in response to evolving regulatory guidance and customer demand.

The move aligns with draft guidance from the U.S. Food and Drug Administration requiring non-bacterial beta-lactam compounds “to be manufactured in a manner that fully prevents cross-contamination with other pharmaceutical products,” according to the announcement. The guidance is intended to strengthen patient safety, as trace exposure to beta-lactams can trigger allergic reactions in susceptible individuals, the company said.

Recipharm contends the new capability enables customers to meet FDA and European Medicines Agency expectations without investing in dedicated in-house infrastructure. The company added that the facility was designed to maintain manufacturing flexibility, speed and continuity of supply while complying with increasingly stringent regulatory requirements.

As a result of the investment, the CDMO said it has secured a partnership with an undisclosed biopharmaceutical company to manufacture non-bacterial beta-lactam tablets. The customer sought a solution that could rapidly meet FDA expectations without committing significant capital or internal resources to building and validating a standalone facility, according to the company.

“Regulatory change should not become a barrier to innovation or patient access,” Recipharm CEO Greg Behar said in a statement. “Our role as a CDMO is to adapt to our customers’ needs and how the market is regulated.”

The partnership includes installing specialized manufacturing capabilities at Recipharm’s Bengaluru, India site. The company said the expansion establishes available capacity to support additional pharmaceutical and biopharmaceutical customers with non-bacterial beta-lactam manufacturing requirements.

The CDMO also recently expanded capabilities at the Bengaluru site with the addition of parenteral development and sterility testing laboratories. The company said those facilities support injectable formulation development, analytical testing and validated sterility testing methods, strengthening the site’s role within its global development and manufacturing network.