IHS Chemical Week


Pharmaceuticals: Quality, Not Tech Capability, Takes Center Stage

4:13 AM MDT | November 3, 2011 | By ALEX SCOTT

One of the big talking points at CPhI Worldwide, the largest expo in the world for pharmaceutical ingredients, which ran last week in Frankfurt, was around the concept of quality. The ability to provide assurances when it comes to product quality and service quality seems to have gained currency in the past year. Yes CEOs of custom synthesis firms were still talking about their company's unique technological capabilities, but discussions at this latest CPhI seemed to swing back more readily to product quality and supply chain security. "We've all got pots and pans," as a CEO of one custom fine chemicals firm told CW.

Several western custom fine chemical firms also tell CW that they have enjoyed an uplift in sales this past year, in part, because they are seeing customers return who had previously sought out lower cost alternatives in Asia and particularly in China. One can only assume that the returning customers have decided that the trade off in price has been more than offset by issues with service and product quality. 

RX360 - an industry-borne initiative to provide assurances around the quality of active pharma ingredients (API) and final drug formulations is now well established. At this year's CPhI Worldwide, however, it was interesting to learn that leading pharma excipients manufacturers such as BASF have got together to mirror the success of Rx360 with a system to ensure product quality along the supply chain of excipients. Named Excipact, the initiative is set to enable more auditing of supply chains while reducing costs through the sharing of those audits. Such a system can only serve to assist companies in their quest to provide quality products and improve transparency along the supply chain.

The initiative draws on the support a number of industry bodies from around the world including the European Fine Chemicals Group (EFCG; Brussels), an affiliate of Cefic, and has the backing of key regulatory bodies including the U.S. FDA. 

Up to 50 excipients manufacturers are expected to join Excipact during 2012. It will be interesting to see who those 50 are - whether it will be predominantly western players or whether leading Indian and Chinese players also search out quality assurance as a differentiator for their businesses.

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