September 3, 2018

Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, announced today the acquisition of a local generics chemical operations API manufacturing facility in Mahad, India, as part of a continuing expansion of its global footprint.

Paolo Tubertini, CEO of Olon, commented, “By acquiring a manufacturing base in India, Olon will have the opportunity to accelerate growth by adding new CDMO projects and to develop new generic products for the Indian market. It comes with a world-class manufacturing facility and a dedicated team of experts that will support us in delivering high-quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements.

Following the acquisition of Ricerca Biosciences’ Chemical Division in mid-2017 and the investment of more than €10 million to expand APIs manufacturing lines in the Settimo Torinese facility, - a leading-edge plant for development and production of APIs and advanced intermediates through microbial fermentation technology - we have now completed a further step in our strategic plan. To accomplish all the objectives listed in the Olon 3 years’ development plan, we will move to the next target: to play an important role in the manufacturing of biologics API’s.”

The Mahad site, which supplies products to Sandoz, a division of the Novartis Group, is an established and reputable API manufacturing facility in India and provides a number of lifesaving medicines to the Indian healthcare system and patients around the world. As part of the asset purchase agreement, the parties have committed to sign a long-term supply contract to guarantee continuous supply of Sandoz products manufactured in Mahad. No impact on jobs is planned and Olon intends to invest in the site and pursue business development opportunities to optimize the plant’s utilization and expand its customer base.

“We look forward to a seamless transition for employees, patients, customers, partners and other stakeholders,” added Mr. Tubertini. “We are impressed by the know-how at the Mahad plant and intend to leverage their expertise to develop new opportunities in the pharmaceutical market, in India and elsewhere.”

The acquisition of the Mahad API manufacturing facility is expected to be completed in early 2019, following a transition process. No financial details were disclosed.

About 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 more than 250 APIs for Generic market and more than 60 between API and chemical Intermediates under CDMO.

Thanks to 1,500 employees, and to the 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), Florham 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.

For further information:

Mrs. Elena Barboni / Olon S.p.A.
Tel.: +39 02 9523 5208 - Email: ebarboni@olonspa.it

FESTIVAL 2018 DELL’INNOVAZIONE E DELLA SCIENZA

CPHI Worldwide in Madrid

Olon on Pharma’s Almanac Magazine

Olon Announces Investment and Expansion of APIs Manufacturing Capabilities

Rodano, Italy – January 26^th, 2018 – Between 2016 and 2017, Olon SpA, European leader of API manufacturing, invested more than 10 million € to expand APIs manufacturing lines in Settimo Torinese facility, which is the leading-edge plant for development and production of APIs and advanced intermediates through microbial fermentation technology. This investment allowed Olon to increase production capacity of APIs up to approx. 1500 kg/year, with different batch sizes up to 30 kg/batch.

This investment included the empowering of DSP (Downstream Process), involving the installation of four (4) different full automated chromatographic columns, besides the installation of six (6) new reactors and a new TFF (Tangential Flow Filtration) unit. Additionally, to isolate lyophilised products in GMP conditions, a new freeze dryer was installed. Utilities and warehouses was empowered with a cold room as well, in order to guarantee the cold chain within the whole process

The investment involved not only the DSP but also the fermentation area. In fact, a fundamental step to increase the yearly capability was the installation of new fermenters equipped with the standard state of art automation system.

The new APIs productive line is GMP compliance and validated. It is part of an ongoing strategic investment campaign in APIs manufacturing, which involves all Olon sites.

OLON acquired RICERCA

OLON SPA (P&R Group) ACQUIRES RICERCA BIOSCIENCES CHEMICAL DIVISION IN OHIO (USA)

Acquisition strengthens service offering of global CDMO and Generics provider for research and manufacturing

Milan (Italy) – June 9, 2017 Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and Generics supplier, announced today the acquisition of Ricerca Biosciences’ Chemical Division of the contract research (CRO) and CDMO based in Concord, Ohio, USA. This acquisition strengthens the service offering of Olon for the pharmaceutical and biotech industry, and to benefits the Ricerca Biosciences customer base by providing large scale manufacturing capabilities in Europe.

Paolo Tubertini, CEO of Olon, commented, "By acquiring a research and manufacturing base in the US, Olon will have the opportunity to accelerate growth by adding new CDMO projects and to develop new Generic products for the American market." Luca Mantovani, OLON Managing Board member, added, "We are delighted to add Ricerca Biosciences to Olon Group, as this strategic step will broaden our contract research and manufacturing services for all our global customers". No financial details were disclosed.

About Ricerca
Ricerca Biosciences is a US-based CRO supporting the development and manufacture of APIs and performance materials in support clinical supply, market development and commercial distribution.  Ricerca’s extensive process/synthetic chemistry, analytical chemistry and engineering expertise provides a synergy that excels at first-time scale-ups and subsequent development of safe, reliable, robust and cost effective manufacturing processes.    Meeting client needs has been the foundation of Ricerca’s business philosophy and is second only to its commitment to safety and regulatory compliance. www.ricerca.com