SMEPAC certification received for an area of OLON F1 production plant

We are pleased to communicate that an area of OLON F1 production plant, at Rodano site, has received the SMEPAC certification.

The plant includes lines 3 and 4 for the production of High Potent Active Ingredients (HAPI) with high containment, recognized OEB4 and OEB5, thanks to the use of specific technologies such as filter driers, isolators for powder loading and unloading (glove-boxes) and high-tech confined areas.

The plant allows to handle substances in isolation according to a scale that varies from OEB1 to OEB5, where OEB5 represents the maximum containment value and that is why, the high performance attributed to our plant, is for us a big potential for the production lines.

The emphasis that this type of plant has received in the last few years is mainly due to the desire to minimize the impact of the manipulation and synthesis of chemicals on the external environment.

For this reason, the production and handling processes of the High Potent Active Ingredients must be carried out safely in equipment that keeps all the material being processed inside it, creating a protective barrier between the operator/external environment and inside the equipment.

OLON invests on solvents materials recovery plant at Rodano site

At the end of 2018, Olon signed an important investment to build a plant for the recovery of solvents materials from chemical productions.

In just over one year, the ambitious project was completed, including: a distillation plant with double batch columns, which allows the recovery of solvents of processes production; 6 storage tanks of distillate solvents and 4 for raw material storage; a control room for programming and monitoring; a laboratory for quality control.

The entire structure has multipurpose capabilities and in a short time the plant will be extended for other processes to recover solvents materials from all Olon sites, which would otherwise be disposed of and lost.

OLON API’s Nitrosamine confirmatory test

The analyses of nitrosamines are challenging. Ultralow levels of these impurities must be quantified in diverse and complex matrices. The developed methods then need to be validated to conform to GMP requirements.

OLON is internally equipped with the required equipment to meet these limits, including Thermo Scientific™ Q Exactive™ Hybrid Quadrupole-Orbitrap Mass Spectrometer.

We have experience with nitrosamine testing, including validating quantitative and test limit methods for our APIs, as well as screening testing methods.

We can provide both toxicological and analytical support for risk evaluation using also third parties qualified suppliers.

OLON announces the opening of 2 new areas at Segrate site

OLON announces the opening of 2 new areas at Segrate site that will help us increasing our production and or know-how:

– a new process safety laboratory able with state of the art equipment such as reaction calorimeter, adiabatic calorimeter and DSC

– a new containment pilot plant: this new investment further strengthens and expands the range of services OLON now can offer to our customers by extending them to a higher level of containment and processing of highly active ingredients

We support those who support us

OLON is a privileged company that, like others, has the benefit and the commitment of continuing industrial activities to produce medicines.

This makes us think about our role: we represent a value for the community and not only for ourselves.

Aware of this, we opened a specific aid program towards all Italian municipalities in which we operate as they are the first structures facing the difficulties of citizens and will proceed on this way.

Some examples of the initiatives we support are: the distribution of masks to citizens in the Municipality of Casaletto Lodigiano; the activation of the psychological listening service in the Municipality of Dorno; the purchase of material for the Red Cross of the Municipality of Capua; free meals for people in difficulty in the Municipality of Mulazzano … and many others.

If we can contribute to our communities it is also thanks to the dedication and resilience that all our employees are showing; for this, we wish to extend the thanks received from the Mayors to all of them.

We are OLON #allinone #dontstopOLON

Olon S.p.A. expands microbial GMP capabilities at its manufacturing site in Capua

Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, celebrates today the start of the construction of a new GMP manufacturing facility at its microbial CDMO facility located in Capua, Italy.

Paolo Tubertini, CEO of Olon, commented, “I am pleased to announce the start of this GMP capacity expansion just within 6 months after the acquisition of Capua BioServices. This truly confirms the real opportunity to accelerate growth in Olon‚ CDMO service positioning and to be recognized as European Leader in the CDMO of microbial fermentation.”

The construction of this new GMP facility is associated to a long-term strategic partnership with a large pharmaceutical company. The engineering project is designed to support the manufacture of multiple products, up to commercial scale. It is a great addition to Olon‚ recent successes in the development and execution of GMP as well as Food-grade engineering projects; from first concept to final commissioning, based on green-field and brown-field, under extremely challenged timelines.

About Olon

Olon is an Italian company providing global services in the field of API manufacturing (including generics) and CDMO services; based on chemistry and biotechnology. Olon offers dedicated solutions for its clients in pharmaceutical and food industry; from R&D to pilot to commercial stage.

In 2018 the company reached a turnover of US$ 500 million with approximately 2000 employees. Headquartered in Rodano (Milan, Italy), Olon has 11 manufacturing facilities spread over Europe (Italy and Spain), USA (Concord OH) and India (Mahad) as well as branch offices in Hamburg (Germany), Florham Park NJ (USA) and Shanghai (China).  Olon combines its unique manufacturing capacity in chemistry (7320 m3) and fermentation (4500 m3), with its track record in API’s (>100 years of experience, >230 API’s) and CDMO (>50 years of experience, >30 projects per year) and with its core capabilities such as fluorination, carbonylation and high-potent manufacturing (>30 HPAPI).

Olon acquires CapuaBioservices S.p.A.

March 18-21, 2019 – NY USA – Meet OLON team at DCAT week

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 ‚Äì 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

Olon Acquires Manufacturing Facility in India

March 18-21, 2019 – NY USA – Meet OLON team at DCAT week

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, Рa leading-edge plant for development and production of APIs and advanced intermediates through microbial fermentation technology Рwe 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

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 ‚Äì 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

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