Gaelic Laboratories Earns BSI Kitemark Certification for Minimized AMR Risk

Gaelic Laboratories, a GMP-approved manufacturer of beta-lactam antibiotics, has obtained BSI Kitemark Certification for Minimized Risk of Antimicrobial Resistance (AMR), recognizing its manufacturing practices aimed at limiting AMR development and aquatic ecotoxicity. The certification follows a multi-month effort to ensure Gaelic’s facilities meet the updated Kitemark requirements for responsible antibiotic production.

The BSI Kitemark has recently been aligned with the AMR Industry Alliance’s Antibiotic Manufacturing Standard, released in May 2025 and effective from January 1, 2026. The standard provides guidance for manufacturers in the global antibiotic supply chain to ensure antibiotics are produced in ways that help minimize the risk of AMR in the environment.

As part of the certification, Gaelic Laboratories adheres to an approved framework for managing antibiotic discharge and employs good practice methods to reduce the environmental impact of manufacturing effluent. The company also regularly reviews its manufacturing operations and supply chains to maintain good practice in controlling antibiotic releases into the environment.

“Gaelic is a young company, established in 2022, and we began work on obtaining this Kitemark in 2024, so the accomplishment is nearly two years in the making,” said Brian Morrissey, general manager of Gaelic Laboratories. He noted that the next goal is to secure the same certification for sister company Athlone Laboratories, so that both organizations are Kitemark-certified for minimized AMR risk, providing an additional assurance to partners and customers.

Courtney Soulsby, BSI global director for healthcare sustainability, said the certification reflects Gaelic’s commitment to responsible antibiotic manufacturing and environmental risk management, and recognizes its contribution to sustainable pharmaceutical production and broader industry efforts to address AMR.

With the Kitemark in place, Gaelic Laboratories is now eligible to apply for membership in the AMR Industry Alliance, a private-sector coalition of more than 90 biotech, diagnostics, generics, and research-based pharmaceutical companies and associations focused on sustainable solutions to curb AMR. Morrissey said Gaelic and Athlone look forward to joining the Alliance to help provide critical medicines for patients in Ireland, Europe, and other regions while applying best practices that support industry-wide efforts to combat AMR.

 


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