Olon
About Olon
We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities.
Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs) in our network of facilities allows clients full access to integrated services resulting in faster production and delivery timelines, with one of the most extensive track records. We rely on synthetic and biological processes both for Generic and Contract Development and the Manufacturing market, in a full cGMPs environment, following ICH Q7 compliance.
With our structured expertise in chemical synthesis and microbial biomanufacturing, we are one of the leading international players of API and HPAPI production. Our sites are equipped with multi-purpose, dedicated lines where we can produce at different levels of high containment, up to OEB 5.
Our expertise is applied to the production of APIs for treatments used in many key therapeutic areas and for some breakthrough pharmaceutical products. We are leaders, among others, in the production of retinoids, antineoplastic, cardiovascular and metabolic diseases compounds, antibiotics and antivirals.
Headquartered in Rodano (Italy), Olon has 11 manufacturing facilities – 8 located in Italy, 1 in Spain (Murcia), 1 in the USA (Concord, Ohio) and 1 in India (Mahad), all compliant with international requirements, 2 branch offices (Florham Park - USA and Mumbai - India), and 2 trading offices (Hamburg - Germany and Shanghai - China). The facilities of Capua and Settimo Torinese (Italy) are biotech centers, while the one in the USA is fully dedicated to R&D.
Vision and Mission
We develop creative ideas and pathways for prompt and sustainable solutions in life science industry.
Olon at a Glance
Our History
Since the foundation, Olon has achieved continuous development that drives our economic growth and global expansion.
We rely on a global network, built up through a pathway of successful acquisitions of companies representing international manufacturing excellence.
2003
Acquisition of:
- Solchem Italiana
- Laboratori Mag
- Antibioticos
Highly specialized in microbial biomanufacturing, one of the most extensive experience of industrial microbial biomanufacturing in UE
2003
2011 - 2012
- OLON establishes the international footprint opening new offices in Shanghai and in USA
- The Group is established, as merging of the acquired companies, and it is named Olon
2016
Acquisition of:
- INFA Group
three further manufacturing facilities
- Labochim, Sifavitor, Italy
- Derivados Quimicos Spain
2016
2017
Acquisition of:
- Ricerca Bioscience, USA
Established as a carve out of the R&D centre
2018 - 2019
- Capua Bioservices becoming one of the first companies in Europe producing with microbial biomanufacturing for third parties
- Novartis API plant in Mahad, India
- Opening Mumbai Offices
2018 - 2019
Research and Innovation
Innovation has driven our business model since ever. We constantly develop technological platforms: a long-term programme in which the Group has invested substantial human and economic resources, in order to explore new technologies or new applications for existing technologies.
The aim is to facilitate the production of new pharmaceuticals and improve the quality and sustainability of the manufacturing process for those which we already produce.
We constantly invest in our sites to upgrade the facilities in terms of GMP and technology standard, and to increase the manufacturing capacity.
We are working on the cutting edge of R&D applied both to chemistry, with flow chemistry, photochemistry and electrochemistry, and to biotechnologies.
Technologies
We have available one of the widest range of leading-edge technologies chemistry and biotechnology expertise, combining well established and novel practices for efficient and successful manufacturing, ensuring safe, fast and cost effective commercial processes.
- High Potent Compound handling capabilities
- Filter driers, isolators and high-tech segregated areas
- Photochemical conversions
- Chromatographic purification
- High pressure hydrogenations
- Cryogenic reactions, Hydrogenation also for acidic substances, Fluorination
- Distillation column
- Biocatalytic transformation
- Controlled substances as psychotropic, lysergic acid intermediate
- Micronization
- Biotechnology expertise Gene Synthesis, - Protein Expression & Production, Recombinant Peptides
R&D Expertise
In Olon, expertise and competence are combined with great flexibility at different levels, namely in the field of microbial fermentation processes - always considering human safety and environmental security.
Our R&D expertise is divided into the following main points:
- In site R&D fully equipped and dedicated analytical R&D laboratory
- High containment labs and C-GMP kilo labs
- Quality by design and design of experiment, taking advantage of parallel synthesis equipment
- Process safety & Scale-up Lab
- Highly innovative team
- Collaborations with University international network
- 300 proprietary patents and patent applications
Quality and Regulatory Expertise
With 350 compounds sold worldwide, Olon has a deep knowledge of global regulations, and this represents a big value for all our partners.
We can translate our Generics expertise in regulatory matters into the CDMO business and, reversely, we found an opportunity to borrow from the strengths of the CDMO business.
Olon not only follows the partner through the entire development journey but is also able to boost the product’s performance and contribute to its business success. 15% of Olon’s total employees work in R&Q affairs, with these results: we manage 300 APIs, 450 DMFs, about 170 active US DMFs and 80 granted CEPs.
Internal excellence serving the customers:
- Regulatory process centralized at the HQ
- Unique point of contact supporting the Partner along the entire process
- Strong internal expertise, high skills and deep know-how
- We submit DMF inside ICH and outside ICH
- We manage them globally, covering all geographic areas, including countries with highest demanding regulatory system as Latin America, Far East, China, Russia, Japan, WHO, Africa Regulatory Bodies, Australia
We are constantly inspected by the Regulatory bodies of all the Countries where we market our products. Olon sites are inspected on regular basis by the local Regulatory Agency, AIFA.
Since November 1, 2017 the EU-FDA mutual recognition agreement (MRA) of GMP inspections, including Italy, has come into force: the MRA allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders.
FDA will continue to perform some inspections in foreign countries but FDA expects to perform fewer routine surveillance inspections in countries like Italy, having a capable inspectorate.
Sustainability
Our concrete commitment is to build new sustainability, involving the company in all operations and business aspects. A new sustainability integrates respect for the environment, with that for the people who work for us, through training and inclusiveness. Finally, a new sustainability that positively influences all those with our Company works: suppliers, public and private bodies, and customers. And, of course, we do not forget all those who use the products we have contributed to develop and produce, as we are aware of the value we are generating in their life.
To validate all our achievements concerning sustainability, in 2022 we were acknowledged with the Bronze Medal of the EcoVadis rating.
- Continuous manufacturing
- Photochemistry
- Electrochemistry
- Biocatalysis
- Microbial fermentation
- Partnerships supporting the communities where our sites are based
- Public-private partnership involving the African state’s own government, aimed at helping the local population suffering from sickle cell disease
- Code of conduct and a declaration of sustainability requirements that we submit to all suppliers and global business partners
- Programs for people development
- Diversity&Inclusion
- Olon School, best practice of STEAMiamoci by Assolombarda
- Great attention to safety, with goal of zero accidents
ESG
Sustainability Targets
Governance
The companies of the Olon Group established the Code of Ethics to define clearly and comprehensively the values which inspire the Group in reaching its goals. Compliance with it is essential for the proper operation, reliability, reputation, and image of the Group, which are fundamental elements for the success and for the current and future development of the businesses operated by Group Companies.
The Organization and Management Model provides an indispensable guide for all our employees and collaborators, and sets out clear codes of conduct, control schemes and measures to prevent crimes and corrupt practices.