Our resources

Leading role

Over the years, our constant commitment has made Roquette a leading supplier of enabling excipients and actives, such as LYCADEX® PF dextrose monohydrate, PEARLITOL® mannitol, KLEPTOSE® betacyclodextrins, LYCATAB® starch derivatives, GLYCOLYS® starch glycolate, NEOSORB®sorbitol and XYLISORB® xylitol.

As the leading producer of polyols, Roquette has always been at the forefront of polyol development, offering the broadest range. This includes PEARLITOL® crystalline mannitol, PEARLITOL® granulated mannitol NEOSORB® liquid sorbitol, NEOSORB® powder sorbitol, SweetPearlTM maltitol, XYLISORB® xylitol and LYCASIN® hydrogenated glucose syrups.

These polyols offer a unique combination of chemical stability with good taste characteristics and sugar-free sweetness suitable for numerous pharmaceutical applications, including solid dosage forms, syrups, pharmaceutical confectionery, injectable formulations and oral care.

Reliability and support -  Dedicated to Quality

To meet the strict pharmaceutical regulatory and quality standards Roquette’s manufacturing plants are regularly audited by international regulatory bodies, such as the US FDA and the European authorities such as the French AFSSAPS.

Those plants involved in the manufacture of pharmaceutical products, notably active pharmaceutical ingredients, are operated to GMP standards such as the European ICHQ7A standards and the US 21CFR standards.

Roquette is actively involved in various international trade associations such as IPEC and quality decision groups within the Pharmacopoeias. An integrated Quality Management System ensures that our products comply with all appropriate standards and a high level of service.

• Analytical certificates are issued with compliance to the principal pharmacopoeia monographs: EP, USP and/or JP.

• A professional audit in-house group provides an inclusive service for all our pharmaceutical ingredients making compliance to regulatory bodies simple yet thorough.

• Product information and questionnaires are compiled in a “CTD”, a worldwide harmonized common technical document format, simplifying drug applications containing our products.

• EP Conformity certificates have been set up for major products with European Pharmacopoeia monographs.

• DMF are prepared and submitted to support the application of our leading products in new drug applications.