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Acceptability of USP-NF and EP Excipients (but not JP) in Japan?

  • 1.  Acceptability of USP-NF and EP Excipients (but not JP) in Japan?

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jan-2023 13:13
    This message was posted by a user wishing to remain anonymous

    Hello!

    This is my first post here, and I would like to thank the community in advance for considering this inquiry.

    We are considering going to Japan soon. However, our one the excipients in the drug product complies with USP-NF and Ph. Eur. quality standards and the previous version of JP, but not the newly updated version of JP.  Will this be problematic in Japan?  Our biggest concern is that the batch could be rejected.

    Thanks!




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