Roquette receives EXCiPACT certification for pharmaceuticals

Roquette granted EXCiPACT certification

Roquette, excipients manufacturer,  has obtained EXCiPACT certification. SGS, one of the international auditors authorised to grant approval under this standard, audited and recommended Roquette’s site in Lestrem, France, to be EXCiPACT certified. Following this recommendation, Roquette obtained its EXCiPACT certification 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)

EXCiPACT certification ensures top-level quality throughout the entire supply chain, and gives the customers access to the full documentation mandatory to the 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.”