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Scientific progress is leading to new molecules and new treatments. Their effectiveness for patients depends on substances – i e excipients – that ensure the active ingredients reach their target. That’s why pharmaceutical laboratories worldwide rely on Roquette research, production, analysis and development.
Making use of Roquette’s pioneering research and technology, our ingredients and excipients have their origins in the abundant harvests of agriculture. Derived from renewable raw materials – whether wheat, maize (corn), potatoes or peas, our expertise turns nature to advantage in a multitude of pharmaceutical applications.
To meet the specific requirements of the pharmaceutical industry, Roquette has created a team of scientists able to investigate chemical, biotechnological, microbiological, toxicological and formulation issues in close collaboration with customers. This is the highly effective basis on which Roquette is able to develop its new excipients and actives, and meet those customers' needs.
The support of its research, control and application laboratories enables Roquette's Pharmaceutical & Cosmetics Business Unit to play a key role in its customers’ development process:
Over the years this dedication has made Roquette a leading supplier of excipients and actives for injectables and dialysis solutions, such as LYCADEX® PF dextrose monohydrate, PEARLITOL® PF mannitol, NEOSORB® PF sorbitol, and XYLISORB® PF 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, MALTISORB® 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.
Roquette’s products and services accord with international standards, including ISO 9001 and relevant GMP. The company’s manufacturing plants are regularly audited by international regulatory bodies, eg the US FDA and the European authorities.
To meet pharmaceutical regulatory obligations, Roquette also supports its products with all the necessary documentation, including:
- Analytical certificates corresponding to the principal pharmacopoeia monographs: EP, USP and/or JP
- EP Conformity certificates
- DMF
- GMO certificates.
Roquette’s commercial network of subsidiaries and agents in Europe, Asia, USA and Africa assure customers worldwide security of supply for its products and services.
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