April 1, 2019

OlonS.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, announces today the closing of the acquisition of the manufacturing facility in Mahad, India.

After an intensive transition period started on September 4^th, Olon India will start definitively all the activities the next April 1st according to the strategy of Olon S.p.A.

Paolo Tubertini, CEO of Olon, commented, “With this acquisition Olon achieved another successful milestone toward our growing strategy.”

Following the acquisition of Ricerca Biosciences’ Chemical Division in mid-2017 and Capua BioServices S.p.A. - the global provider of CDMO services in the field microbial fermentation in January 2019 - we have now completed a further step in our strategic plan. With this acquisition, Olon has successfully finalized its 3 years’ development plan, we will move to the next target: to play an important role in the manufacturing of biologics API’s.

The CEO of OLON India Mr Claudio Massari, told: “A new most important journey will start for Mahad site with the new company Olon API India Pvt Ltd. I am looking forward to the future of this company in India as one of Company leader in the API manufacturing not only for the Indian market but for the entire world. Thanks to the excellent facility, strong experienced and talented people, I’m proud to lead Olon India and sure of the long success”.

After the carve out from Sandoz, as part of the asset purchase agreement, the parties have committed to sign a long-term supply contract to guarantee continuous supply of products manufactured in Mahad. The plant’s main product is Rifampicin - used to treat several types of bacterial infections, including tuberculosis - and its derivate.

Olon intends to invest in the site and pursue business development opportunities to optimize the plant’s utilization and expand its customer base.

The new company Olon API India Pvt Ltd. has already launched important investment project, establishing a new head office in Mumbai, hiring additional people, improving the organization and Indian market presence and beginning a Technology Transfer introducing new production to the Mahad site.

The Mahad site, which supplies products to Sandoz, a division of the Novartis Group,is an established and reputable API manufacturing facility in India with a reaction capacity of 580 m³ and approximately 270 employees. This site provides a number of lifesaving medicines to the Indian healthcare system and patients around the world, with a 2018 turnover equally divided between Indian and foreign markets.

About Olon

OLON is an Italian company leader in the production of Active Pharmaceutical Ingredients (APIs) via synthesis and biological processes for the generic market and for contract development and manufacturing (CDMO) requirements.

Complementary to its activities is the Dossier Unit, whose team of dedicated professionals work on the development of the Finished Drug Formulations (FDFs) and the preparation of the Common Technical Documents (CTD) dossier.

Turnover in 2018 of US$ 400 million, with more than 230 APIs (20 under CMO) for the Generic market and 33 chemical intermediates (under CMO).

Olon is holder of about 155 active US DMFs and 69 granted CoS. and is able to handle several particular process technologies, such as Fluorination, Carbonylation and Fermentation.

With 2000 employees, of which 200 alone are in the specialized R&D team, Olon offers complete integrated packages and services to support full development of APIs based on strong knowledge in both Chemical and Biological process, all in full cGMPs and with regulatory coverage.

Headquartered in Rodano (Milan, Italy), Olon has 10 manufacturing facilities – 8 located in Italy, 1 in Spain and 1 in USA, all compliant with 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.

January 25, 2019

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 Capua BioServices S.p.A., a global provider of CDMO services in the field of microbial fermentation, as part of a continuing expansion of its global footprint.

Paolo Tubertini, CEO of Olon, commented, “By acquiring Capua BioServices, Olon will have the opportunity to accelerate growth by adding new CDMO projects and to be recognized as European Leader in the CDMO of microbial fermentation (total fermentation capacity of 4.500 m3). It comes with a world-class manufacturing facility and a dedicated team of experts that will support us in delivering high-quality services that meet or exceed customer expectations.

Following the acquisition of Ricerca Biosciences’ Chemical Division in mid-2017 and the manufacturing site in Mahad (India), announced in Q3 2018 with closing in Q1 2019, we have now completed a further step in our strategic plan. With this acquisition Olon has successfully finalized his 3 years’ development plan.”

Capua BioServices is a global provider of high-quality services in the field of custom microbial process development and manufacturing. Capua BioServices offers dedicated solutions for proteins, specialty small molecules and microorganisms for applications in pharma, food, feed and other bio-industrial markets. The site is beta-lactam free with a total fermentation capacity of about 1.400 m3, located in Capua, nearby Naples (South of Italy) with approximately 200 employees. Over the past 60 years, the company has built a track record based on extensive experience in working with a variety of bacterial, yeast and fungal systems. 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.

About Olon

OLON is an Italian company leader in the production of Active Pharmaceutical Ingredients (APIs) via synthesis and biological processes for the generic market and for contract development and manufacturing (CDMO) requirements.

Complementary to our activities is the Dossier Unit, whose team of dedicated professionals work on the development of the Finished Drug Formulations (FDFs) and the preparation of the Common Technical Documents (CTD) dossier.

Turnover in 2018 of US$ 400 million, with more than 250 APIs (31 under CMO) for the Generic market and 33 chemical intermediates (under CMO).

Olon is holder of about 130 active US DMFs and 50 granted CoS. and is able to handle several particular process technologies, such as Fluorination, Carbonylation and Fermentation.

With 1,500 employees, of which 200 alone are in the specialized R&D team, Olon offers complete integrated packages and services to support full development of APIs based on strong knowledge in both Chemical and Biological process, all in full cGMPs and with regulatory coverage.

Headquartered in Rodano (Milan, Italy), Olon has 10 manufacturing facilities – 7 located in Northern Italy, 1 in Spain 1 in USA and 1 in India, all compliant with 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.

In addition to pharmaceutical certifications, Olon has dedicated areas for food-grade manufacturing and complies with Kosher, Halal and from 2018-Q2 with FSSC 22.000.

For further information please contact:

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

September 4, 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

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