小林化工株式会社が承認を有する医薬品の承認申請に関する不適切行為への対応について｜厚生労働省

This page announces that Kobayashi Pharmaceutical Co., Ltd. engaged in improper conduct related to drug approval applications for multiple pharmaceuticals under its approval. Through field investigations and company reports, the facts were confirmed. The Ministry will impose strict administrative sanctions following administrative procedures. The improper conduct involved falsifying stability test implementation dates and using manufacturing methods different from those stated in the approval application. However, post-approval stability tests confirmed that all affected drugs showed no quality, efficacy, or safety issues.