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CPhI Report Indicates a Need for Greater Third Party Certification to Ensure GMP Vigilance
Date:7/26/2013

onger be taken for granted and a signed paper is no guarantee" added Malhotra.

As to the source of most APIs and ingredients unsurprisingly over 45% answered India followed by 25% for China and 19% for Europe as the top supplier. More interestingly however, 62% of respondents said they have focused their solid dose efforts onto extended release and orally disintegrating forms.  

Chris Kilbee - Group Director, CPhI & Pharma - commenting on the success of CPhI's first monthly insight report: "This report has highlighted some really striking findings that both suppliers and pharma need to take account of, particularly in relation to quality and inspections, as it is impossible in a globalised environment to inspect every pharmaceutical ingredients plant on the planet- so independent certification is a must. Beyond this, it is clear that in terms of formulation for NCEs bioavailability and stability remain difficult to achieve with the proliferation of more complex drug compounds. And in fact, it is likely that as certification improves, pharma will increasingly look to outsource the development process and it is from this increased competition that solutions to formulation issues will be found. In the future, this will enable drug targets that were previously unworkable and reformulations of existing compounds to make it through the development cycle and on to commercial supply."

For a copy of the full report please visit: http://www.pharmaevolution.com/lg_redirect.asp?piddl_lgid_docid=560465&piddl_lg_pcode=featuredrightcolumn

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