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Analytical Support
Hovione has experience and capabilities to provide analytical services for Drug Substance, Drug Product and Inhalation Drug Product at all stages of development and commercial phases.
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Regulatory Affairs
Hovione has filings with every world health authority that has a DMF system for APIs including FDA EDQM PMDA,MHRA, HPRA, Infarmed among others.
Certificate of Suitability (CEP)
EP Certificates - Granted by EDQM
Hovione DMFs at FDA
List of DMFs
Article / Jan 01, 2012
A hybrid approach to reach stringent low genotoxic impurity contents in active pharmaceutical ingredients: Combining molecularly imprinted polymers and organic solvent nanofiltration for removal of 1,3-diisopropylurea
Separation and Purification Technology (2012), 86, 79-87
Article / Jan 01, 1995
Aspects of the stereospecific hydrogenation of the exocyclic double-bond of methacycline
Actas Encontro Nac. Catal. Basica Apl. (Ind. Ambiental), 3rd (1995), 271-82
Article / Jan 01, 2012
Carcinogenic pollutants in drug manufacturing
Magyar Kemikusok Lapja (2012), 67(2), 34-37
Article / Jan 01, 2012
Design of experiments as a tool for LC-MS/MS method development for the trace analysis of the potentially genotoxic 4-dimethylaminopyridine impurity in glucocorticoids
Journal of Pharmaceutical and Biomedical Analysis (2012), 70, 251-258
Article / Jan 01, 2012
Design, preparation and characterization of novel molecularly imprinted polymers for removal of potentially genotoxic 1,3-diisopropylurea from API solutions
Separation and Purification Technology (2012), 86, 190-198
Article / Jan 01, 2013
Environmental and economic analysis for selection and engineering sustainable API degenotoxification processes
Green Chemistry (2013), 15(1), 210-225