Olon wins 2020 CMO Leadership Awards

We are proud to announce that Olon has won the 2020 CMO Leadership Awards for Capabilities, Quality and Reliability.

We would like to thank our external partners for evaluating our company with such a positive response and all our colleagues for their daily efforts that contributed to the achievement of this important recognition.

#Olon #CMO #Awards

Copertura assicurativa dipendenti – Covid 19

Carissimi Colleghi,

Sono felice di comunicarVi che, per tutelare la salute dei nostri dipendenti, abbiamo deciso di attivare una copertura assicurativa specifica per il rischio di infezione da Coronavirus, rivolta a Voi ed ai collaboratori della nostra Società, in aggiunta alle coperture già in essere per gli incidenti professionali ed extraprofessionali e per i rischi di viaggio.

La copertura assicurativa prevede un’indennità di ricovero, un’indennità di convalescenza ed una serie di interventi di assistenza post ricovero (invio di un medico, trasporto in ambulanza, trasferimenti, supporto di baby sitter/collaboratore familiare per un certo numero di ore).

Vogliamo dare un reale sostegno ai nostri dipendenti in caso di necessità ed io, personalmente, desidero ringraziarVi ancora una volta per l’impegno e la dedizione che state dimostrando in questo periodo così critico.

#andratuttobene

Olon measures

As a pharmaceutical-chemical company our role is more important than ever at this critical moment: to keep on supplying medicines to pharmacies and hospitals.

We want to share with everyone what OLON is doing in order to give opportunity to other companies in foreign countries to be ready in case the outbreak is also reaching them.

In our industry the role of each single company is important and we need to actively maintain the entire complex supply chain.

OLON has implemented the following measures:

  • Strict sites access control, by checking the health status of those entering the sites
  • Regularly and thoroughly cleaning your hands with an alcohol-based soap or wash them with soap and warm water.
  • Frequently washing all the surfaces (door handles, desks, PCs, telephones, desks etc.) in order to guarantee proper sanitization.
  • Maintain at least 1 meter (3 feet) distance between yourself and anyone who is coughing or sneezing
  • Activities reorganized to decrease the simultaneous presence of people in the same place, at the same time working remotely, the number of people onsite has drastically decreased.
  • Avoid touching eyes, nose and mouth with the hands
  • Make sure you, and the people around you, follow good respiratory hygiene practices. This means covering your mouth and nose with your elbow fold or tissue when coughing or sneezing. Then dispose of the used tissue immediately.
  • Stay home if you feel sick. If you have fever, cough and difficulty breathing, seek and call medical attention.
  • Stay informed on the latest developments about COVID-19. Follow the advice given by your healthcare professional, your national and local public health authority or your employer on how to protect yourself and others from COVID-19.
  • Crowding situations should be avoided, prevention measures of the safety distance greater than 1 meter must be absolutely respected. High critical areas for example the cafeteria, and the dressing areas.
  • All cafeteria and break areas in our plants and HQ are closed.
  • For the changing rooms, in Italy, we distributed the workers at shift changes in small groups, in order to reduce the number of people present at the same time in the changing rooms and the result impact in the case one of the workers tested positive for coronavirus.
  • All the workers must use a protective mask at least FFP3
  • In order to optimize the use of light protection masks FFP3 (possible risk of shortage), semi/full face masks with proper filters are to be preferred for working activities in the plant
  • Other risk areas are offices and laboratories. People must stay in their offices and avoid moments of aggregation. The continuous use of the protection mask FFP3 is mandatory and a safety distance of more than 1 meter (3 feet) each other must be kept.
  • Avoid meetings, use phones and WebEx.
  • Use sanitizers for changing rooms, cafeteria, computers, and furnishings.
  • People must guarantee absolute compliance with hygiene rules and prevention measures even outside the factory or office.
  • As we are asking for a change in behavior, in addition to making provisions, adequate supervision and control must be guaranteed, immediately correcting the wrong behaviors.

Take care of your health and protect others around you by also taking the same measures outside the company and by following some practical advice in your daily life:

  • Take the empty lift or avoid taking it
  • If possible avoid public transportation, especially if it is crowded
  • Use e-commerce, if possible
  • Limit social life and preferably the use of social areas.
  • Limit contact with people over 70, they are the weakest and the most exposed category

Please feel free to send us  your comments and  suggestions at info.coronavirus@olonspa.it

Stay Safe!

Paolo Tubertini

CEO Olon

#olonwedontstop

#olonwedontstop

Italy is responding to a serious health emergency due to the outbreak of COVID-19.

OLON fully supports the actions undertaken by the Italian Government which are aligned with OLON corporate values, the ethics and the responsibility that the company has towards citizens, employees and clients.

OLON has encouraged smart working to manage the emergency and to contribute to the public safety.

#olonwedontstop

OLON workers are allowed to reach the workplace and to return home on a daily basis, the sites in Italy are operative and in compliance with the regulation issued by the Italian Government. Manufacturing activities are proceeding and final products are delivered to OUR CUSTOMERS!

#olonwedontstop

OLON informs you that the actions undertaken by the Italian Government are not including any particular restriction to the freight transport (raw materials, finished goods). As of today OLON has delivered all the manufactured goods to the forwarding agents for worldwide shipping.

Olon would like to say thank you to all partners for their incredible commitment and strong support. More than ever, your contribution is essential to support the health of human beings!

#olonwedontstop

Paolo Tubertini – CEO Olon

Olon updates

Esteemed Partners and Colleagues,

In this critical and challenging period, Olon informs you that our activities are regularly proceeding.
We are very conscious of our role and duty in delivering APIs (active pharmaceutical ingredient) for more than 100 million patients around the world.
We are doing our utmost to preserve our partner’s service continuity through our Italian and foreign sites, to give strong support in these particular circumstances of health care that is going through worldwide.

Olon, as already informed, is proactively following all official recommendations and fully in compliance with the regulations issued by the Italian Ministry of Health and with the rules of the Prime Ministerial Decree 20200308 of 08.03.2020 issued by the Italian Government.

Olon would like to say thank you to all employees and partners for their incredible commitment and strong support. More than ever, your contribution is essential to support the health of human beings!

Paolo Tubertini – CEO Olon

“Olon is proud to collaborate with Novartis and its partners to help make hydroxyurea more broadly available and in a sustainable way”

The government of Ghana has announced the availability of hydroxyurea for the treatment of people with sickle cell disease (SCD), marking the official launch of a first public-private partnership of its kind.

Mr. Tubertini, CEO of Olon, commented: “it was an honor to be invited by our partner Novartis to be present for the kick-off announcement on November 7th. We are proud to contribute to turn down this disease that afflicts the African continent by making hydroxyurea available to patients in Ghana. As a demonstration of our commitment to patients with sickle cell disease we will sponsor 12.000 treatments by supply of hydroxyurea.”

Please also see below official announcement:

Government of Ghana makes hydroxyurea available to people with sickle cell disease through first of its kind public-private partnership with global medicines company Novartis

  • Government is already working to accelerate inclusion of the medicine and associated laboratory testing in the National Health Insurance Scheme
  • Novartis has already delivered more than 20 000 treatments and is committed to implementing two clinical trials with novel biologic treatment for sickle cell disease
  • Partnership includes establishing national treatment guidelines, newborn screening, and centers of excellence for treatment of sickle cell disease; making accessible treatment options available in line with the global standards of care; and using digital technologies to monitor and evaluate patient registration, report real-time data, and help ensure safe large scale roll-out of medicine
  • 15 000 babies are born with sickle cell disease every year in Ghana

Accra, Ghana, November 6, 2019 Today, the Government of Ghana announced the availability of hydroxyurea for the treatment of people with sickle cell disease (SCD), marking the official launch of a first of its kind public-private partnership to improve the diagnosis and accelerate treatment for people with SCD. The launch follows the signature of a  Memorandum of Understanding in January among the Ministry of Health of Ghana, Ghana Health Service, the Sickle Cell Foundation of Ghana and global medicines company Novartis to create a holistic approach to help manage the disease. Ghana is the first African country to commit to offering the global standard of care for their people with SCD.

“I am proud of this bold partnership, and it is my hope that, through this collaboration, we will help ease the pain and improve the lives of people living with sickle cell disease in our country. We are committed to put SCD among the priorities on our national health agenda and to take the necessary steps to make treatment broadly available through our National Health Insurance Scheme, bringing much-needed relief to families struggling to cover the cost of care for their loved ones,” said H.E. Alhaji Dr. Mahamudu Bawumia, Vice President of the Republic of Ghana. “Our collective goal is to reimagine what the future could look like for people with sickle cell disease: where children do not need to miss out on school or be singled out; where young adults can have equal opportunity for employment; and where families can flourish and continue to be the bedrock of our civil society—in a nutshell, we will make every effort to ‘normalize’ sickle cell disease within the Ghanaian society.”

To date, Novartis has delivered more than 20 000 treatments of hydroxyurea. Initially, the therapy will be made available through 11 trained treatment centers, as well as through private distribution channels, and is expected to cover the needs of patients for up to 12 months. The partners aim to open more treatment centers by the end of the year, and Novartis is committed to delivering a total of 60 000 treatments. Discussions are already underway for inclusion of the medicine and associated laboratory testing in the National Health Insurance Scheme, as well as prioritizing SCD as a national program.

Hydroxyurea is a commonly used medicine for patients with SCD in developed countries, and is approved for use in both adults and children. In October 2018, the Ghana FDA granted marketing authorization to Novartis hydroxyurea, making it the first time that hydroxyurea will be available for this indication in Ghana. A recent study, published in the New England Journal of Medicine indicates that hydroxyurea treatment is effective and safe in children with SCD in sub-Saharan Africa and reduces the incidence of pain events (vaso-occlusive crises),  malaria, blood transfusions, and death.

“All the traditional names by which SCD is known allude to the episodes of severe pain experienced by people with the disease,” said Prof. Kwaku Ohene-Frempong, MD, President of the Sickle Cell Foundation of Ghana and Program Coordinator for the National Newborn Screening Program for Sickle Cell Disease. “Hydroxyurea is a drug with proven efficacy in reducing pain episodes and other complications of the disease. Currently, the highest standard of care for people with SCD starts with early diagnosis through newborn screening followed by penicillin prophylaxis to prevent early death from infection, and hydroxyurea therapy to ease the pain, prevent other complications and improve quality of life.”  

At the same time, Novartis has committed to develop a child-friendly formulation of hydroxyurea and has announced plans to conduct two clinical trials in Ghana and Kenya for its next-generation treatment for SCD, crizanlizumab. Crizanlizumab is a novel targeted biologic therapy that is expected to help reduce pain crises in people with SCD. The trials are expected to start in 2020; this will be the first time that a biologic therapy, which is not a vaccine, enters multicenter clinical trials in sub-Saharan Africa (excluding South Africa).

“Novartis is deeply committed to reimagining medicine for patients in Ghana and across Africa,” said Vas Narasimhan, MD, CEO of Novartis. “Building on our long heritage of addressing malaria and leprosy in Africa, we’re excited to help improve the diagnosis and treatment of people with sickle cell disease here in Ghana. Novartis is proud to join this pioneering partnership, which could accelerate efforts to forge a healthier future for children across the continent.”

Sickle cell disease is recognized by the World Health Organization as a public health priority and a neglected health problem in sub-Saharan Africa. Approximately 80% of individuals with SCD globally are born in sub-Saharan Africa, and there is evidence to suggest that more than half of affected individuals may die before the age of five due to preventable complications. In Ghana, it is estimated that 15 000 babies are born with sickle cell disease every year2.

The five-year partnership aims to improve and extend the lives of people with SCD through a comprehensive approach to screening and diagnosis; treatment and disease management; training and education; and elevating basic and clinical research capabilities. Specifically, the partners aim to collaborate on field testing and implementation of SCD treatment guidelines, the establishment of centers of excellence across regions and the implementation of newborn screening at these centers. In addition, partners plan to employ digital technologies to monitor and evaluate patient registration, report real-time data and help ensure safe large scale roll-out of medicine.

In parallel, Novartis is working with Zipline, a California-based automated logistics company, to make sickle cell treatments widely available, especially in rural areas. Zipline is already operating two distribution centers in Ghana, in Omenako and Asante Mampong, with plans to open two more in the near future.

In addition, in order to help further ensure a sustainable supply of high quality hydroxyurea, Novartis has entered a strategic collaboration with Olon, a manufacturer based in Italy that supplies the active ingredient for the drug. “We are proud to collaborate with Novartis and its partners to help make hydroxyurea more broadly available and in a sustainable way,” said Paolo Tubertini, CEO of Olon. “As a demonstration of our commitment to patients with sickle cell disease and this program, we will also contribute, without cost, the active ingredient to cover approximately 12 000 thousand treatments. Our hope is to continue to meet the needs and challenges of those living with sickle cell disease and their families to improve access to quality health care.”

About Sickle Cell Disease

Sickle cell disease is a debilitating, inherited blood disorder. It causes affected red blood cells to become sickle-shaped, stiff and fragile – easily breaking apart. Blood vessels and blood cells become sticky due to damage caused by sickle cells and ongoing chronic inflammation. That leads to blood cells sticking to each other and to the blood vessels and causing blockages – called vaso-occlusion –  which can lead to the acute episodes of pain (known as sickle cell pain crises or vaso-occlusive crises), stroke and other life-threatening complications5. It is a lifelong illness that can put an emotional, physical, and financial burden on patients and their families.

SCD is a global health problem, with the highest burden of disease concentrated in sub-Saharan Africa. In countries in West, Central and East Africa, the prevalence of the sickle cell gene is between 10 to 30 percent, while in some areas it is as high as 45%. It is estimated that approximately 1 000 children in Africa are born with SCD every day and more than half die before they reach five years of age. This is due primarily to lack of early diagnosis through newborn screening, penicillin prophylaxis, parental education, and comprehensive care. In resource-poor countries, more than 90 percent of children with SCD do not survive to adulthood1. Despite the adoption by the WHO of an SCD strategy for Africa in 2010, the disease is largely absent from the global or national health agenda.

http://www.moh.gov.gh/hydroxyurea-sickle-cell-medicine-now-available-in-ghana/

Mahad plant becomes Olon

Olon S.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 4th, 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. Рthe global provider of CDMO services in the field microbial fermentation in January 2019 Рwe 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 Рused to treat several types of bacterial infections, including tuberculosis Рand 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.√ó

Olon S.p.A. is a worldwide leader in the development and production of APIs (Active Pharmaceutical Ingredients).
The ideal partner for custom synthesis and contract manufacturing projects.

NEWS & EVENTS

Mahad plant becomes Olon


April 1, 2019Olon announces the completion of the acquisition of Mahad plant in India.READ MORE

OLON at DCAT 2019


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