Roquette company obtained EXCiPACT™ certification

4 April 2016

EU regulations require drug manufacturers to audit their starting material suppliers. The audit is to demonstrate Good Manufacturing Practice (GMP) compliance.

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EXCiPACT™ (International Excipients Certification) is an international certification scheme for manufacturers, suppliers and distributors of starting material for pharmaceuticals. Roquette company being one of the world leaders of pharmaceutical excipients manufacturers has taken a significant step forward in improving its customer service with the obtention of the EXCiPACT™ certification.     

The obtained certificate confirms that Roquette’s Lestrem (France) based site produces pharmaceuticals according GMP certification standard. Roquette obtained the certificate in December 2015 for the following excipients:

·      Native starches (maize and wheat // B grade)

·      Pregelatinised starches (product line LYCATAB®)

·      Modified starches (product line GLYCOLYS®)

·      Monohydrate and anhydrous glucoses

·      Sorbitol powders (product line NEOSORB® P xx and XTAB xx)

·      Sorbitol solutions (product line NEOSORB® 70/xx and POLYSORB® 85/70/00)

·      Maltitol powders (product line SweetPearl®)

·      Maltitol solutions (LYCASIN® 80/55, LYCASIN® 75/75 and POLYSORB® 75/55)

·      Mannitol powders (product line PEARLITOL® xx and PEARLITOL® Flash)

·      Xylitol powders (product line XYLISORB®)

 

Roquette company is the fifth French enterprise having obtained EXCiPACT™ certificate starting from 2013 and at the moment it is just the 29th EXCiPACT™ approved company in the world.

EXCiPACT™ certification ensures top-level quality of the starting material supplied by reliable suppliers.  Also the scheme provides access to the full documentation required for manufacturers’ internal quality management as well as documentation mandatory for regulators.

«This certification is a new milestone in our commitment to customers» said Paul Smaltz, Roquette’s Head of Pharma Global Business Unit: «Roquette wants to offer best-in-class services to its customers, and the EXCiPACT™ certification was a must-have to us. The implementation of quality and safety best practices as required by EXCiPACT™ offers our customers the possibility to significantly reduce the number of audits. It means for them cost and time savings, while enjoying premium quality products.»

Roquette is committed to satisfy its customers’ demands and new certification shows once again its sustainable partnership approach.