Gaelic Labs gains BSI Kitemark™ Certification for Minimized Risk of AMR

Gaelic Laboratories, a GMP-approved manufacturer of Beta-Lactam antibiotics, has successfully obtained BSI Kitemark™ Certification for Minimized Risk of Antimicrobial Resistance (AMR), demonstrating a commitment to responsible manufacturing.

Gaelic Laboratories is committed to maintaining high manufacturing standards that minimize the risk of developing AMR and aquatic ecotoxicity in the environment. This commitment has now been recognised through the attainment of BSI Kitemark™ Certification for Minimized Risk of AMR. This achievement is the result of many months’ work at Gaelic Labs to ensure the company’s facilities meet the stringent requirements to achieve this gold-standard accreditation for responsible manufacturing.

The BSI Kitemark™ has transitioned recently to align with the May 2025 release of the AMR Industry Association’s Antibiotic Manufacturing Standard, effective from 1 January 2026. The Standard provides clear guidance to manufacturers in the global antibiotic supply chain to ensure that our antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.

Therefore, the certification demonstrates that Gaelic Laboratories practices the responsible manufacturing of antibiotics and addresses environmental waste concerns. For example, Gaelic Laboratories commits to an approved framework for managing antibiotic discharge, and to good practice methods to avoid the environmental impact of manufacturing discharges. The company also continually reviews its manufacturing and supply chains to ensure good practice in controlling releases of antibiotics into the environment.

“We are proud of this achievement,” says Brian Morrissey, General Manager of Gaelic Laboratories.  “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. The next step, which is already ongoing, is to achieve the same certification for our sister company Athlone Laboratories. Both of our companies will then be Kitemark™ certified for minimized AMR risk, and that will be an important guarantee to our partners and customers.”

Courtney Soulsby, BSI Global Director, Healthcare Sustainability, adds “Gaelic Laboratories has achieved BSI Kitemark™ Certification for Minimized Risk of AMR, reflecting its commitment to responsible antibiotic manufacturing practices and environmental risk management. This certification recognizes the company’s efforts to support sustainable pharmaceutical manufacturing and contribute to wider industry initiatives aimed at addressing antimicrobial resistance.”

Having obtained the certification, Gaelic Laboratories is now eligible to apply for AMR Industry Alliance membership. The AMR Industry Alliance is one of the largest private sector coalitions set up to provide sustainable solutions to curb AMR globally, with over 90 biotech, diagnostics, generics and research-based pharmaceutical companies and associations joining forces.  

“We are very much looking forward to Gaelic and Athlone Laboratories joining this industry group,” continues Brian. “We share the goals in terms of providing critical medicines for patients in Ireland, Europe and other parts of the world, while leveraging best-practices to support a broad industry momentum to fight AMR. Membership of this Alliance will better enable us to support those objectives, along with other leading pharmaceutical manufacturers across the world.

For more information about Gaelic Laboratories, visit at www.gaelic.com.

Editor’s Note

For more information, please contact Tristan Jervis at Impact Shine Communications on +44 (0) 771 363 8396 or e-mail: t.jervis@impactshinecommunications.com.

About Gaelic Laboratories

Gaelic Laboratories is a world-class manufacturer of Beta-Lactam (penicillin) products in tablet, capsule and powder for suspension form. Established in Ireland in 2022, and with newly upgraded facilities, we manufacture our own Beta-Lactam products (sold under the Gaelic Laboratories brand), as well as offering contract manufacturing and packaging services for markets across the EU, UK, the Middle East and North Africa. Our site in Ireland is licenced by the HPRA.

About Athlone Laboratories

Athlone Laboratories a leading developer and manufacturer of a broad range of oral dose beta-lactam products. Established in 1974, the company is an accredited supplier to local and many blue-chip customer partners across Europe, Asia-Pacific, Canada, Iraq and Brazil Our site in Ireland is licenced by the HPRA. Athlone Laboratories was acquired by Gaelic Laboratories in December 2025.

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