[RegAffairs]Container Closure for Tablets ANDA

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[RegAffairs]Container Closure for Tablets ANDA

To: "RegAffairs" <RegAffairs@www2.pharmweb.net>
Subject: [RegAffairs]Container Closure for Tablets ANDA
From: "Kams" <rules20012@yahoo.co.in>
Date: Fri, 3 Oct 2008 14:06:26 +0100
Delivery-date: Fri, 03 Oct 2008 14:02:50 +0100
Envelope-to: hm0090@www.pharmweb.net
Operating-System: PharmWeb - http://www.pharmweb.net
Reply-To: "RegAffairs" <RegAffairs@www2.pharmweb.net>
Sender: <RegAffairs@www2.pharmweb.net>

Does somebody have experience in using the HDPE bottle/closure which 
do not have USDMF for products meant for US distribution? Does FDA 
allows using bottles/closure which does not have DMF for commercial 
distribution?

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Kams
rules20012@yahoo.co.in


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