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Gaelic Laboratories Gains BSI Kitemark Certification for Minimized AMR Risk

COMPANY PROFILE
  • Gaelic Laboratories has obtained BSI Kitemark™ Certification for Minimized Risk of Antimicrobial Resistance (AMR), recognizing its responsible antibiotic manufacturing practices.
  • The certification aligns with the AMR Industry Alliance’s Antibiotic Manufacturing Standard and supports the company’s efforts to manage antibiotic discharge and reduce environmental risks.

Gaelic Laboratories has obtained BSI Kitemark™ Certification for Minimized Risk of Antimicrobial Resistance (AMR), becoming recognized for its efforts to support responsible antibiotic manufacturing and environmental risk management. The GMP-approved manufacturer of beta-lactam antibiotics said the certification reflects its commitment to maintaining manufacturing standards that minimize the risk of AMR and aquatic ecotoxicity in the environment.

The certification follows work undertaken since 2024 to ensure the company’s facilities meet the requirements of the BSI Kitemark program. According to Gaelic Laboratories, the certification now aligns with the AMR Industry Alliance’s Antibiotic Manufacturing Standard released in May 2025 and due to take effect on January 1, 2026. The standard provides guidance for manufacturers across the antibiotic supply chain on responsible production practices.

Gaelic Laboratories said the certification demonstrates its commitment to managing antibiotic discharge and implementing manufacturing practices designed to reduce environmental impact. The company also stated that it regularly reviews its manufacturing operations and supply chain to help control releases of antibiotics into the environment.

“We are proud of this achievement. 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.”

Brian Morrissey, General Manager of Gaelic Laboratories

Following the certification, Gaelic Laboratories is eligible to apply for membership in the AMR Industry Alliance, a coalition of more than 90 biotechnology, diagnostics, generics, and research-based pharmaceutical companies and associations focused on addressing antimicrobial resistance. The company also stated that work is underway to obtain the same certification for its sister company, Athlone Laboratories.

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