- Recipharm has established a dedicated manufacturing facility for non-bacterial beta-lactam tablets in response to updated FDA guidance and customer demand.
- The investment has resulted in a partnership with an innovative biopharmaceutical company seeking compliant contract manufacturing capacity.
Recipharm has developed a new, dedicated manufacturing facility for non-bacterial beta-lactam medicines to meet updated regulatory expectations and customer requirements. The investment follows the US Food and Drug Administration’s final draft guidance calling for full prevention of cross-contamination between non-bacterial beta-lactam compounds and other pharmaceutical products.
The FDA guidance aims to improve patient safety, as even trace exposure to non-bacterial beta-lactams can cause allergic reactions in susceptible individuals. In response, Recipharm adapted its manufacturing strategy to align with these requirements and established a purpose-built capability for tablet production that complies with both FDA and European Medicines Agency regulations.
The dedicated facility enables customers to meet regulatory expectations without investing in their own infrastructure, while maintaining speed, flexibility and continuity of supply. The approach supports companies seeking compliant CDMO and contract manufacturing solutions under increasingly stringent regulatory oversight.
As a direct outcome of the investment, Recipharm has secured a partnership with a biopharmaceutical company to manufacture non-bacterial beta-lactam tablets. The collaboration includes the installation of specialised manufacturing capabilities at Recipharm’s site in Bengaluru, India, creating capacity to support additional pharmaceutical and biopharmaceutical clients.
“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.”
Greg Behar, CEO at Recipharm
