Recipharm, a global Contract Development and Manufacturing Organization (CDMO), has established a new, dedicated facility for non-bacterial beta-lactam medicines. This investment directly addresses the latest regulatory guidance from the U.S. Food and Drug Administration (FDA).
Ensuring safety and cross-contamination prevention
The FDA’s guidance mandates that non-bacterial beta-lactam compounds must be manufactured in a manner that fully prevents cross-contamination with other pharmaceutical products. This requirement aims to enhance patient safety, as even trace exposure can trigger allergic reactions in susceptible individuals.
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Regulatory compliance: The facility is designed to comply with both U.S. FDA and European Medicines Agency (EMA) requirements.
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Location and scope: The expansion includes the installation of specialized manufacturing capabilities at Recipharm’s site in Bengaluru, India.
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Strategic partnership: Following this investment, Recipharm has secured a major partnership with a biopharmaceutical firm to manufacture non-bacterial beta-lactam tablets.
Strategic vision
Greg Behar, CEO of Recipharm, stated that regulatory shifts should not hinder innovation or patient access. This strategic expansion not only supports current collaborations but also establishes a platform with available capacity to serve additional pharmaceutical companies with non-bacterial beta-lactam manufacturing needs.