To import APIs which are confirmed with severe quality management, we support foreign API manufacturers who securely perform GMP control to be accredited as foreign manufacturers and introduced in Japan. Moreover we assist Japanese Licensed Marketing Approval Holders (of drugs) to get and keep their approvals with working as an in-country caretaker of DMFs and supporting a GMP compliance review of foreign manufacturers.

  • Support of Accreditation of Foreign Manufacturers
    In case the manufacturer of APIs is a foreign company, it must be accredited as a foreign manufacturer to supply APIs to Japan. If the foreign manufacturer is not accredited and has no agent in Japan, we work as the agent for the foreign manufacturer to make them get accreditation.
    Accredited Foreign Manufacturers
  • List of Products of which Koa Shoji Works as an In-Country Caretaker
    In Japan, after the revision of the Pharmaceutical Affairs Law in 2005, API manufacturers can register the API’s name, manufacturing process and others in DMF: Drug Master File. If the manufacturer is a foreign company, their in-country caretaker is necessary. The in-country caretaker manages not only registration of DMF, but also changes after the registration, notification of changes to the users, and closure of the DMF. We are in charge of such　work by the request of our customers.
    We work as in-country Caretaker of: