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March 2015

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Subject:
From:
Radwan Almofti <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Mon, 23 Mar 2015 20:36:18 +0000
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Hi Everyone,

Could you please let me know if I can use an API that will expire soon to manufacture a finished product with shelf life that will pass the expiry date of that API?

For example, if I want to use Ibuprofen that will expire in June 2015 to make the tablets or oral liquid or any other finished dosage forms that has the shelf life of 3 years which means that Ibuprofen will expire in the tablets (or other dosage forms) while they are being consumed.

Is that acceptable by GMP/CGMP, FDA and/or other regulatory bodies such as Health Canada or EMA?

Many thanks,

Radwan

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