AMR

SHIONOGI aims to ensure that all manufacturing processes for antibiotics handled by SHIONOGI obtain the international certification “BSI Kitemark™ for Minimized Risk of AMR” from the British Standards Institution (BSI) by fiscal year 2035. Through third-party evaluation, this initiative is intended to objectively guarantee that antibiotics are manufactured responsibly with consideration for AMR occurrence and to clearly demonstrate this to stakeholders.

 

Furthermore, to reduce the environmental impact during the manufacturing process of antibiotics, SHIONOGI conducts audits (AMR audits) and provides feedback to its own group factories and suppliers (Table 1) that handle antibiotics and their drug substances/intermediates, aiming to achieve proper management of antibiotic environmental emissions throughout the supply chain.

AMR audits at SHIONOGI are conducted based on the “Antibiotic Manufacturing Standard” *¹ established by the AMR Industry Alliance (AMRIA) *². These audits confirm the existence of management systems, status of wastewater and solid waste management, and compliance with environmental emission standards, thereby ensuring a global standard for controlling and managing antibiotic release into the environment.

In addition to the existing categories of ‘Drug products’ and ‘APIs’, we have added ‘Primary Packaging’ and revised the labeling method accordingly.

Company E has been removed as it is no longer a supplier to SHIONOGI.

 

*2  Antibiotic Manufacturing Standard (External link)

In May 2025, the Standard was revised to add “primary packaging” to the previously targeted pharmaceutical and formulation processes. Accordingly, when planning AMR audits from fiscal year 2026 onward, suppliers entrusted only with primary packaging will also be audit targets.

Company E has been removed as it is no longer a supplier to SHIONOGI.

○: Conforms to the “Standard”
△: Partially non-conforming to the “Standard”; corrective actions are being implemented
×: Multiple non-conformities with the “Standard”; corrective actions are being implemented

At the Kanegasaki Plant, SHIONOGI’s flagship antibiotic manufacturing facility, wastewater generated during the manufacturing process is treated for antibiotic inactivation in each manufacturing building as part of efforts to control and manage emissions. The treated wastewater is discharged via the wastewater treatment facility at the site.

 

In addition, the concentration of antibiotics in the wastewater discharged from the site is evaluated annually based on the AMRIA Standard. For all five antibiotic products currently manufactured at the Kanegasaki Plant, the concentration in the wastewater is below the “environmental emission standard value”*⁴, indicating that there is no impact when released into the natural environment. Concentration evaluation is conducted using direct measurement by high-performance liquid chromatography and mass balance calculation based on the manufacturing volume and wastewater volume.

 

If any abnormality is detected, the wastewater is temporarily diverted to an emergency storage tank and is collected and treated to prevent discharge into the natural environment.

 

External specialists collect and incinerate the solid waste generated from the antibiotic manufacturing process, ensuring that antibiotics are not released into the environment via solid waste.

 

For antibiotics manufactured by suppliers, AMR audits have confirmed compliance with environmental emission standards for three out of four products manufactured by four domestic companies. Corrective actions are being implemented for one product at one company where compliance was not confirmed. Similarly, for four products manufactured by four overseas companies, compliance has been confirmed for three products at three companies, and corrective actions are underway for one product at one company. SHIONOGI will continue to conduct AMR audits for domestic and overseas suppliers and verify compliance with environmental emission standards.