Gaelic Laboratories earns BSI Kitemark certification for AMR manufacturing

Gaelic Laboratories, a GMP-approved manufacturer of beta-lactam antibiotics headquartered in Ireland, received BSI Kitemark certification for minimized risk of antimicrobial resistance (AMR), reportedly recognizing the company’s responsible antibiotic manufacturing and environmental risk management practices.

According to the company, the certification aligns with the AMR Industry Alliance’s Antibiotic Manufacturing Standard released in May 2025 and effective Jan. 1, 2026. The standard establishes guidance for antibiotic manufacturers to help reduce AMR risk associated with pharmaceutical production and environmental discharge.

Gaelic Laboratories said the certification followed nearly two years of work to ensure its manufacturing operations met the environmental and operational requirements associated with the standard. The company noted that its manufacturing framework includes controls for antibiotic discharge management, environmental monitoring, and supply chain oversight intended to minimize antibiotic release into the environment and reduce aquatic ecotoxicity risk.

“We are proud of this achievement,” Brian Morrissey, general manager of Gaelic Laboratories, said in a statement. “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,” Morrissey added. “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.”

According to the company, the certification also makes Gaelic Laboratories eligible to apply for membership in the AMR Industry Alliance, a coalition of more than 90 pharmaceutical, biotechnology, diagnostics, and generics organizations focused on addressing antimicrobial resistance globally.

“Gaelic Laboratories has achieved BSI Kitemark Certification for Minimized Risk of AMR, reflecting its commitment to responsible antibiotic manufacturing practices and environmental risk management,” Courtney Soulsby, global director of healthcare sustainability at BSI Group, said in a statement.

Gaelic Laboratories said it intends to pursue the same certification for Athlone Laboratories following its acquisition of the company’s antibiotic manufacturing operations in late 2025. That transaction transferred ownership of the Ballymurray manufacturing facility in Ireland, which produces oral beta-lactam antibiotics including amoxicillin, flucloxacillin, and penicillin products for customers in Ireland, the United Kingdom, Europe, and other international markets.

The Athlone acquisition was intended to strengthen regional supply security for essential antibiotics, while supporting continued investment in manufacturing capacity and technical capabilities in Ireland, according to Gaelic Laboratories.