Obtained BSI Kitemark™ for Minimized Risk of AMR Certification

In October 2025, Shionogi Pharma Co., Ltd. Kanegasaki Plant (hereinafter, “Kanegasaki Plant”), part of the SHIONOGI Group (“SHIONOGI”), obtained the international certification “BSI Kitemark™ for Minimized Risk of AMR*1” (“this certification”) for both the active pharmaceutical ingredient (API) manufacturing and formulation manufacturing processes of cefiderocol, a treatment for multidrug-resistant Gram-negative bacterial infections.

This certification system was established in 2023 by the British Standards Institution (BSI) to promote responsible manufacturing of antibiotics across the global supply chain. The certification verifies that the antibiotic manufacturing processes are appropriately managed in accordance with international standards for controlling the discharge of hazardous substances into aquatic environments and preventing the spread of antimicrobial resistance (AMR). Certification is granted for each combination of “pharmaceutical product,” “manufacturing facility,” and “manufacturing process (API manufacturing or formulation manufacturing).”

The Kanegasaki Plant is one of Japan’s leading facilities for the integrated manufacturing of antibiotics, from API to formulation. The plant has established a rigorous system for controlling and managing antibiotic discharge into the natural environment. By obtaining this certification, the Kanegasaki Plant has been objectively assured by a third-party organization that cefiderocol is manufactured in accordance with international standards, with minimal environmental impact.