Toward the Establishment of a Supply

Antibacterial substances (hereafter, antibacterial drugs), especially β-lactam antibacterial drugs including cephem antibiotics*1 focused in this supply securing plan, are not only used for the treatment of infectious diseases, but for the prevention of infection associated with surgical operations. as a recommended drug in clinical guidelines. Meaning, it has extremely high medical need. Nevertheless, almost 100% of its raw materials are dependent on imports from overseas, and has been pointed out as a risk that affects the stable supply of antibacterial drugs to clinical practice in Japan. In fact, a long-term supply shortage happened about cefazolin sodium, which is widely used as a β-lactam antibacterial drug, in 2019 due to manufacturing problems in China, which accounts for the largest proportion of its suppliers. And it occurred that had a serious impact on the medical care service in Japan. Considering these supply chain issues, antibacterial drugs have been designated as "specified important materials" based on the provisions of Article 7 of the Act on Economic Security Promotion Bill, and considerations are underway, led by MHLW, to secure a stable supply of antibacterial drugs for domestic use.

*1 A general term for antibiotics with a β-lactam ring in the molecule, classified into penicillins, cephems, carbapenems, etc.

Authorized business

Shionogi Pharma Co., Ltd., Pharmira Co., Ltd.

Specified Important Materials

Cefazolin sodium, Cefmetazole sodium

Initiatives

Introduce manufacturing equipment for active pharmaceutical ingredients, etc., and develop a stockpiling system

Certification date

July 28, 2023

1. Effort Policy for Securing Stable Supply of Antimicrobial Substance Preparations https://www.mhlw.go.jp/content/001039660.pdf

2. Pharmaceutical Stable Supply Support Project Public Recruitment for Implementing Operators (First Public Recruitment) https://www.mhlw.go.jp/stf/newpage_12086.html

3. Pharmaceutical Stable Supply Support Project Public Recruitment for Implementing Operators (Second Public Recruitment) https://www.mhlw.go.jp/stf/newpage_17823.html

4. Pharmaceutical Stable Supply Support Project Public Recruitment for Implementing Operators (Third Public Recruitment) https://www.mhlw.go.jp/stf/newpage_25875.html

For Further Information, Contact:

SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html