A new, highly automated production line, multi-purpose and high containment, suitable for the synthesis of highly active ingredients
Milan - The Group's new results have been announced by Olon, global leader of APIs production, upon the closure of the 2020 financial statements: the company confirms its trend of organic growth, the success of the integration process of the industrial and research and development activities of the numerous sites acquired in recent years, achieving its absolute historical record in terms of revenues, technical and R&D investments.
Olon closed its books with numbers that reflect a gradual and constant growth over the last five years: 65 million in strategic investments over 2021, focusing to boost most advanced technology platforms and expanding production capacity as well. The forward-looking strategy of the Italian Group focuses on production of highly potent active principles.
In the context of this exceptional international growth, the Rodano (Milan) site has been subject to major investments which have allowed the plant to significantly increase its production capacity and to raise its process quality standards, along with its environmental sustainability and the safety of its workers. The plant has extensive experience and capabilities in the development and manufacturing of highly potent APIs from clinical to commercial scale. In 2021 alone, the Rodano site received investments of 13 million to bolster it on several fronts.
Olon is pleased to announce the completion of a new highly potent API large scale production line, already available for customers. A new, highly automated production line, multi-purpose, and high-containment, suitable for the synthesis of highly active ingredients.
Rodano site, that relies on one of the most extensive expertise in handling highly potent pharmaceutical principles at global level, has raised the level of containment up to the actual standards and very large scale putting in place a set of primary and secondary containment designed to avoid the active substances diffusion in the working environment.
The line significantly strengthens the synthesis, finishing and drying section, to manage acid-based reactions and it can produce batches up to the significant quantity of 250 kg, with a necessary containment band of OEB5, for either highly active or highly toxic products (OEL 0,1-1 micrograms/m3).
“Our new production line in Milan is part of a development capacity expansion to address the strong market demand and furtherly reinforce our historical expertise in handling highly potent pharmaceutical ingredients. This additional capacity benefits customers by expediting the onboarding of new projects” comments Paolo Tubertini, Group Chief Executive Officer
Finally, the group, in line with its vision, has invested major resources into workplace safety, protection of individuals and protection of the environment. “Our aim is to continue to grow. We play a leading role as an Italian company but also as representatives of an industry that is crucial to public health and to the drug supply chain. We hope to pave the way to bring back to Europe the production of active ingredients, which represent the heart of the drug” concludes Roberta Pizzocaro, President of Olon Group.
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With a 2020’s Turnover of 530 Mio$, OLON supplies 34 Chemical Intermediates and more than 295 APIs for the Generic market.
Thanks to all the 2.200 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 160 active US DMFs and 79 granted CoS.
Always considering human safety and environmental security, OLON handles different and not-common manufacturing process technologies, such as Fluorination, Carbonylation and Fermentation – combined with chemical synthesis to produce APIs for the majority, proteins, high-value small molecules & microorganisms (application in pharma), food, feed, and other bio-industrial markets.
Headquartered in Rodano (Milan, Italy), OLON has 11 manufacturing facilities - 8 located in Italy, 1 in Spain, 1 in USA and 1 in India, designed in compliance with the strictest international requirements, and 3 branch offices in Hamburg (Germany), Florham Park NJ (USA) and Shanghai (China).
The manufacturing sites are regularly inspected by the most important national and international Authorities, and regularly audited by our partners and customers. The facilities are FDA-inspected and self-identified under GDUFA.
Besides pharmaceutical certifications OLON complies with ISO standards (14001), has dedicated areas for food-grade manufacturing and complies with Kosher, Halal and within 2018-Q3 also 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).