The post doesn't describe if this is a small molecule or a biologic. Assuming this is a small molecule, you may request an IND number from CDER that you can reference in the importation documentation. Specify in the importation paperwork that this is a CDER IND number. Use a reputable importer who understands the documentation required by FDA. Also indicate that the API is not for clinical trial use and not for commercial sale.
However, check with a reputable shipper/importer about the paperwork needed for importation.
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Mark De Rosch FRAPS
Chief Regulatory Officer, Epizyme, Inc.
Laconia NH
United States
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Original Message:
Sent: 09-Nov-2020 14:57
From: Anonymous Member
Subject: Import/Export
This message was posted by a user wishing to remain anonymous
How does one import from the EU an API that has neither and NDA nor an IND in effect and will be used to produce clinical product in the USA for an IND in the USA?