logo roquette
Formulation-related
General Regulatory
Packaging & Storage Conditions
Quality Status
Stability or Tox Studies
back send to friend print

Are Roquette products GMP certified?


GMP, or Good Manufacturing Practices, are a set of official production standards and as such only make sense when the appropriate reference is indicated.

Probably the most widely recognised GMP standards for active ingredients are the ones defined by the US FDA under  legislation  21 CFR, part 210-211. For instance, Roquette's LYCADEX® PF has been assessed on repeated occasions and has met these standards.

However, there are other institutions that have set different GMP guidelines, such as WHO and IPEC.  The question of GMP certification has to be considered in the context of the specific product and local regulatory requirements.

For more information on specific products, please contact us or your local Roquette representative.


Are Roquette products GMO-free?

Do Roquette APIs conform to ICHQ7A?

top