Depends on the intended use. I and the company I represent import APIs to the US for various uses.
Note that APIs are in fact all in violation of the Act and ise certian labeling and end-use statements, AoCs to remove the appearance of the violation.
The information you have provided this far is not enough for any one to make a call as to how to import the DS (API).
If you would like more information feel free to contact me via my Biddle Sawyer Pharma email.
Grunwell@biddlesawyer.com------------------------------
Lisette Grunwell MS
Director, Regulatory & Technical Affairs
Old Lyme CT
United States
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Original Message:
Sent: 31-Aug-2018 10:01
From: Anonymous Member
Subject: Import of API to manufacture DP in the US
This message was posted by a user wishing to remain anonymous
Does anyone know how one can import the API from outside the US into the country for DP manufacture in the US without an open IND. What is the process involved and what documentation is required.