GMP Synthesis and Production

GMP manufacture of cyclodextrins, process validation, regulatory documentation
1 The cyclodextrin component
of a cyclodextrin-enabled
medical diagnostic tool needs to
be of consistent quality for
reproducibility reasons. This
criterion can only be met via
GMP manufacturing.

Likewise, cyclodextrins used in
clinical trials are also essential to be
manufactured under GMP conditions.
CycloLab offers
manufacturing cyclodextrins
and certain cyclodextrin-enabled
formulations under cGMP conditions
in its in-house clean area, which has
authorized for manufacturing pharmaceutical ingredients.

This offer is also ideal for
cyclodextrin-based clinical
investigational products where a
simplified preclinical safety study
is adequate.
3 Our offer includes the compilation
of the product specification and
related analytical services as well
as stability studies.

Once a comprehensive data
package is compiled we can
support our customers with
every necessary information for
filing DMF/CTD/IMPD dossier.
The production output of our
site reaches several kilograms,
a capacity ideal for medical
diagnostic tools and clinical
investigational products.

Higher demands can be
met via technology transfer to
an industrial partner of CycloLab.

Links on the page:
  • Manufacturer's license from the Hungarian National Institute of Pharmacy to produce non-sterile formulations and clinical investigational products

If you are interested in this service offer: