Fw: Excipients for ANDA

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Fw: Excipients for ANDA

To: "RegAffairs" <RegAffairs@www2.pharmweb.net>
Subject: Fw: Excipients for ANDA
From: "Rashmi" <rashmivs@cipla.com>
Date: Wed, 16 Mar 2005 06:40:46 +0000
Delivery-date: Wed, 16 Mar 2005 04:40:07 +0000
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>

Dear Vimal,

If the excipient is not official in USP, then you can analyse the
excipients as per EP method, but instead of claiming as per EP, you have to
mention analysed as per in-house method.

Best regards,
Rashmi Shetty

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