If you mean when can you transfer ownership of an ANDA, that can be done at any time. Of course, if you do it during the review, it may complicate matters. And, if you do it after approval, the purchaser, if it is not acquiring the actual manufacturing facility named in the ANDA where the drug is made, will need to make arrangements to continue manufacturing at that facility. Otherwise, to transfer manufacturing facilities to one not covered by the original ANDA may require extensive additional work and likely even a new bioequivalence study.
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Michael A. Swit, Esq.
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Original Message:
Sent: 03-04-2013 16:16
From: Audrey Egan
Subject: Transfer of ANDA holder
At what point during the ANDA application process can one change ANDA holders? Would they need to gain approval of the ANDA first or can it be changed during the review of the ANDA? What type of documentation would be needed? Thank you for your response in advance.