The National Medical Products Administration (NMPA) recently conducted an on-site inspection of the Hofu Plant of KYOWA HAKKO BIO CO.,LTD. in Japan (Company Name: Hofu Plant of KYOWA HAKKO BIO CO.,LTD.; Address: 1-1 Kyowa-cho, Hofu-shi, Yamaguchi, Japan). The inspection revealed that the plant's production of glutathione (Registration No.: Y20190009115), acetylcysteine (Registration No.: Y20190009075), tryptophan (Registration No.: Y20190009135), phenylalanine (Registration No.: Y20190009095), and L-valine (Registration No.: Y20190009077) did not comply with the approved information. The plant was found to be engaging in practices such as relabelling and packaging purchased raw materials or refining purchased crude products, which are not in compliance with China's Good Manufacturing Practices for Drugs (2010 revision) and relevant drug review and approval requirements.
In accordance with the "Pharmaceutical Administration Law of the People's Republic of China" and other relevant regulations, the NMPA has decided, effective immediately:
1. To suspend the import of the above-mentioned registered raw materials produced by the Hofu Plant of KYOWA HAKKO BIO CO.,LTD. Drug supervision and administration departments at various ports will cease issuing import clearance certificates for these products.
2. The "Joint Review and Approval Result" for the above-mentioned registered raw materials in the "Raw Material, Packaging Material Registration Information" of the NMPA Center for Drug Evaluation will be adjusted to "I" (i.e., not passed joint review and approval with the preparation).
3. The above-mentioned registered raw materials shall not be used in the production of drug preparations. Preparations already produced using these raw materials shall not be released; for preparations that have already been released to the market, the drug marketing authorization holder shall immediately conduct an investigation and assessment and take necessary risk control measures based on the assessment results.
This is hereby announced.
National Medical Products Administration
March 11, 2025
