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GMP Synthesis and Production
16 March, 2017
GMP manufacture of cyclodextrins, process validation, regulatory documentation
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 been
authorized for manufacturing pharmaceutical ingredients
This offer is also ideal for cyclodextrin-based clinical investigational products where a simplified preclinical safety study is adequate.
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
technology transfer to an industrial partner of CycloLab.
Links on the page:
from the Hungarian National Institute of Pharmacy to produce non-sterile formulations and clinical investigational products
Order sheet for custom GMP synthesis
if you have further questions!
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