Regulatory Open Forum

Hello Everyone,

Is it possible that the owner of an ANDA be a corporate office?  The corporate office would not do any manufacturing or perform any testing services, but would manage facilities that do manufacture and perform testing.

Thanks,
Sarah

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Sarah Green
Knoxville TN
United States
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Yes!

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GRSAOnline
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Original Message:
Sent: 17-Oct-2018 11:39
From: Sarah Green
Subject: ANDA owner question

Hello Everyone,

Is it possible that the owner of an ANDA be a corporate office?  The corporate office would not do any manufacturing or perform any testing services, but would manage facilities that do manufacture and perform testing.

Thanks,
Sarah

------------------------------
Sarah Green
Knoxville TN
United States
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Thank you.  Would this be an administrative change?

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Sarah Green
Knoxville TN
United States
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Original Message:
Sent: 17-Oct-2018 13:24
From: Narayan Rao
Subject: ANDA owner question

Yes!

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GRSAOnline

Original Message:
Sent: 17-Oct-2018 11:39
From: Sarah Green
Subject: ANDA owner question

Hello Everyone,

Is it possible that the owner of an ANDA be a corporate office?  The corporate office would not do any manufacturing or perform any testing services, but would manage facilities that do manufacture and perform testing.

Thanks,
Sarah

------------------------------
Sarah Green
Knoxville TN
United States
------------------------------