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Colorcon, Inc. Quality by Design (QbD) Expertise Beneficial in Compliance with New FDA Guidelines
Date:9/19/2012

WEST POINT, Pa., Sept. 19, 2012 /PRNewswire/ -- Colorcon, Inc., (http://www.colorcon.com) a world leader in the development and supply of formulated coatings and other excipients for the pharmaceutical and nutritional supplement industries, announces customer access to valuable expertise in film coating formulation and process applications to assist pharmaceutical manufacturers with their Quality by Design (QbD) initiatives. Starting in January 2013, the FDA expects drug manufacturers to implement QbD principles in their Abbreviated New Drug Applications (ANDA).  The FDA QbD guidelines provide guidance on pharmaceutical product development and manufacturing to facilitate design of products and processes that maximizes the product's efficacy and safety while enhancing product manufacturability.

"For more than fifty years, Colorcon has remained a credible, industry-leading, partner in the development of fully formulated coating systems and has worked alongside formulators and drug product manufacturers while offering superior technical support," said Kamlesh Oza, General Manager, Film Coatings. "This plethora of experience puts Colorcon at the forefront in providing customers with industry leading insight into QbD principles for film coating.  Pharmaceutical companies can feel confident knowing that QbD principles have been used to develop and manufacture robust Opadry® fully formulated film coating products and systems in all Colorcon facilities world-wide that are consistent, predictable, reliable and controlled."

Colorcon has resources available for its customers as they prepare to meet the new FDA expectations.  Additionally, to provide its customers with valuable technical knowledge, Colorcon has hosted a series of webinars on the topic of QbD for the Pharmaceutical Industry.  To access previous webinars, please visit

SOURCE Colorcon, Inc.
Copyright©2012 PR Newswire.
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