Colorcon, Inc.’s UK Site Adds EXCiPACT Certification To Support Pharmaceutical Customers To Reduce Growing Regulatory Requirements

Harleysville, Pennsylvania, USA, 28th May 2015. ISO9001 certified for over 20 years and a founding member of the International Pharmaceutical Excipient Council (IPEC) Colorcon Ltd, today announces that it has been awarded EXCiPACT™ certification for its long established excipient manufacturing site in Dartford, UK.

David Bain, Managing Director, Colorcon Europe explains “EXCiPACT™ is an additional certification scheme for pharmaceutical excipients that demonstrates to customers our continued commitment to quality and managing risk on their behalf. Colorcon views EXCiPACT™ as a complementary element of our pledge to continuous improvement of our already established quality systems helping our customers reduce total cost of ownership”.

According to Kevin McGlue Colorcon Director of Global Quality Assurance and IPEC member “Colorcon has aligned its Quality Management System (QMS) with the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients. Colorcon Limited has also undergone regular voluntary GMP inspections with the UK Medicines and Healthcare Products Regulatory Agency (MHRA), resulting in confirmation of compliance with the IPEC-PQG Guide. Colorcon is inspected and meets the requirements of appropriate licencing bodies around the world. In China, Japan and India, Colorcon operates under full pharmaceutical manufacturing license, and is inspected and approved according to pharmaceutical GMP”.

For over 20 years, the Quality Management System (QMS) used by Colorcon Limited has been independently certified as meeting the requirements of ISO9001.

Company Information

Colorcon is a world leader in the development, supply and technical support of speciality excipients: formulated film coating systems, modified release technologies, and functional excipients for the pharmaceutical industry. Our best-in-class products and technologies are complemented by our extensive application data and value-added services to support all phases of solid oral dose design, development and manufacture. Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on superior product quality, unparalleled technical support, extensive regulatory assistance and reliable supply from multiple locations. Colorcon has 9 manufacturing facilities, 18 technical service laboratories globally and more than 1200 employees exclusively dedicated to its customer base.

For more information, visit www.colorcon.com.

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