Olon SpA Information

One OLON Olon is an Italian company world leader in the Active Pharmaceutical Ingredients (APIs) production, using synthetic and biological processes for Generic market as well as in Contract Development and Manufacturing (CDMO). Recently the Dossier Unit has been enlarged, considering the development of the Finished Drug Formulations (FDFs) and the preparation of the Common Technical Documents (CTD) dossier. With a 2017’s Turnover of 400 Mio$, Olon supplies 33 Chemical Intermediates (under CMO) and more than 250 APIs (31 under CMO) for the Generic market. Thanks to 1,500 employees, and to highly qualified R&D team – more than 200 people – Olon can offer complete integrated packages and services to support the full development of APIs based on strong knowledge in both Chemical and Biological process, all of them under a full cGMP and regulatory coverage – holder of about 130 active US DMFs and 50 granted CoS. Always considering human safety and environmental security, Olon handles different and not-common manufacturing process technologies, such as Fluorination, Carbonylation and Fermentation. Headquartered in Rodano (Milan, Italy), Olon has 9 manufacturing facilities – 7 located in Northern Italy, 1 in Spain and 1 in USA – compliant with international requirements, and 3 branch offices: Hamburg (D), Floram Park NJ (USA) and Shanghai (China). All manufacturing sites are regularly inspected by the most important national and international Authorities, and regularly audited by our partners and customers. All plants are FDA-inspected and self-identified under GDUFA. Besides pharmaceutical certifications, Olon has dedicated areas for food-grade manufacturing and complies with KOSHER, AHLAL and from 2018-Q2 with FSSC 22.000. To be highlighted Olon’s growing cooperation with Universities: University of Milan (Italy), Milan Politecnico (Italy), University of Pavia (Italy, University of Murcia (Spain), and PROMIDIS (Milan University spin-off).