You are here: Home ยป Archives for Centrient Pharmaceuticals

Centrient Pharmaceuticals announces its achievement of a significant milestone in the clean production of antibiotics

Rijswijk, The Netherlands, May 19, 2022 (GLOBE NEWSWIRE) —

Summary

  • Centrient Pharmaceuticals reached a significant milestone in the clean production of its antibiotics, with the lowest environmental impact and minimizing the potential contribution to antimicrobial resistance
  • The company is the first to publicly announce that Its entire supply chain of oral antibiotics "" including its own and supplier manufacturing sites – is fully compliant with the stringent Predicted No Effect Concentration (PNEC) discharge targets set by the AMR Industry Alliance
  • This achievement demonstrates Centrient Pharmaceuticals' commitment and leadership in the responsible production of antibiotics.

Centrient Pharmaceuticals announces 100% compliance with the stringent Predicted No Effect Concentration (PNEC) discharge targets set by the AMR Industry Alliance for clean manufacturing of its full oral antibiotics product range. This standard covers both Centrient's sites and its suppliers' sites. This achievement positions the company as a frontrunner in the industry with the delivery of responsibly–produced antibiotics, which minimize the possible contribution to antimicrobial resistance.

The PNEC discharge target is the concentration of an antibiotic in water at which there is unlikely to be a risk of adverse environmental effects or of antimicrobial resistance (AMR) developing. These scientific, risk–based targets were developed by the AMR Industry Alliance and cover around 120 active pharmaceutical ingredients (APIs) used in antibiotic manufacturing. Each individual antibiotic has a corresponding PNEC value, published in the AMR Industry Alliance table of Recommended PNECs for Risk Assessments (updated periodically).

High concentrations of antibiotic residues in factory wastewater can create hotspots of resistant bacteria which may lead to AMR. While manufacturing is just one of the contributors to the emergence of AMR in the environment, its impact cannot be overlooked. AMR is a major threat to global public health as well as to the healthcare industry. Many standard medical procedures such as organ transplants, chemotherapy, and surgeries such as caesarean sections become much more dangerous without effective antibiotics to prevent and treat infections. Antibiotics are the cornerstone of our modern healthcare system, and complying with PNEC standards enables manufacturers to ensure supply of these critically important medicines does not contribute to the risk of AMR.

The PNEC values are increasingly being recognized as the standard for antibiotic discharge concentrations in water and are expanding beyond Alliance companies and their supply chains. For example, tenders in the UK and Germany (health insurer AOK) include a specific reference to the PNEC discharge targets. Also, companies assessed externally by organizations such as the Access to Medicine Foundation will have public exposure for their performance on PNECs.

As a strong advocate for sustainable manufacturing, Centrient Pharmaceuticals became a founding board member of the AMR Industry Alliance in 2017, working with partners to raise awareness and deliver solutions to the AMR issue. Since then, the company's own journey to reaching full compliance has included establishing state–of–the–art wastewater treatment facilities at all their sites worldwide and developing tests for measuring antibiotic activity in wastewater streams, leading to a fully clean and PNEC–compliant supply chain.

"We are proud to be the first in our industry to publicly announce PNEC compliance for our oral antibiotics product supply chain.

At Centrient Pharmaceuticals, our commitment to Sustainability is in our DNA "" we ensure that the way in which we produce pharmaceuticals has the lowest environmental impact and does not contribute to AMR. We are proud of our PureActives enzymatic low–carbon technology, ISO 14001 certification of all our sites, and Board positions at the Pharmaceutical Supply Chain Initiative and AMR Industry Alliance.

We will continue to work with customers, suppliers, industry and government decision–makers across the value chain to make the supply and buying of antibiotics sustainable to curb AMR.", says Rex Clements, CEO at Centrient Pharmaceuticals.

Read our whitepaper "Manufacturing sustainable antibiotics for the future' here.

—————————————————————————————————————————————————————————————–


About Centrient Pharmaceuticals

Centrient Pharmaceuticals is the global leader in the production and commercialisation of sustainable antibiotics, next–generation statins, and anti–fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.

We stand proudly at the centre of modern healthcare, as a maker of essential and life–saving medicines. With our commitment to Quality, Reliability and Sustainability at the heart of everything we do, our over 2,200 employees work continuously to meet our customers' needs. We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.

Founded 150 years ago as the "Nederlandsche Gist– en Spiritusfabriek', our company was known as Gist Brocades and more recently DSM Sinochem Pharmaceuticals. Headquartered in Rijswijk (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.

For more information please visit www.centrient.com or contact Centrient Pharmaceuticals Corporate Communications, Alice Beijersbergen, Director Branding & Communications. E–Mail: alice.beijersbergen@centrient.com.

About the AMR Industry Alliance

The AMR Industry Alliance was formed in 2017. With approximately 100 life sciences companies and trade associations, it represents nearly one–third of the volume of sales and the majority of all novel products. Members have committed to report on activities they are undertaking in the areas of research & science, access to antibiotics and appropriate use of these, as well as responsible environmental manufacturing to tackle the rapid spread of antimicrobial resistance. If AMR remains unchecked, the annual death toll could climb from 700,000 each year to 10 million by 2050 and the economic impacts could be on par with those of the 2008 financial crisis. The AMR Industry Alliance ensures that signatories collectively deliver on the specific commitments made in the Industry Declaration on AMR and the Roadmap for Progress on Combating AMR and measures progress made in the fight against AMR.

Forward–looking statements

This press release may contain forward–looking statements with respect to Centrient Pharmaceuticals' future financial performance and position. Such statements are based on current expectations, estimates and projections of Centrient and information currently available to the company. Centrient cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. Centrient has no obligation to update the statements contained in this press release, unless required by law. The English language version of the press release is governing.


GLOBENEWSWIRE (Distribution ID 8545387)

Centrient Pharmaceuticals boosting statins API manufacturing capacity

Rotterdam, The Netherlands, June 21, 2021 (GLOBE NEWSWIRE) —

Summary:

  • Centrient Pharmaceuticals has started production at its newly built statins API manufacturing unit in Toansa, India.
  • With this expansion the company is doubling its production capacity of Atorvastatin and Rosuvastatin, meeting the increased demand for its high–quality uniquely produced statins.
  • Centrient Pharmaceuticals' statins are one of the most sustainably produced in the industry by eliminating harmful solvents, generating less waste, and a reduced carbon footprint of 32% as compared to traditional manufacturers.
  • Using backward integrated manufacturing methods, and dedicated production facilities, Centrient Pharmaceuticals is able to offer its customers security of supply.

Centrient Pharmaceuticals ("Centrient"), the global leader in sustainable antibiotics, next–generation statins and anti–fungals, announced today to have started production at its new statins manufacturing unit. With the building of its second dedicated unit on the Toansa site in India now completed, the company will double its statins production capacity. This will enable Centrient to meet growing demand for its sustainably manufactured Atorvastatin and Rosuvastatin Active Pharmaceutical Ingredients (APIs).

Statins are currently the most prescribed drug class globally for the treatment of high cholesterol and cardiovascular diseases and are among the top–selling drugs worldwide. The markets for Atorvastatin and Rosuvastatin in particular, has shown steady growth in the past years, as a result of the continued global prevalence of high cholesterol issues, replacement of older generation statins, and genericization of the market.

Starting almost a decade ago, Centrient has grown today into one of the leading statin API suppliers worldwide, servicing large pharma companies around the globe.

Next to high–quality features like long shelf life and large batch sizes, the company offers security of supply to customers through its dedicated statins production facility and backward integration. Being backward integrated, Centrient is independent from external imports of starting materials. Its enzymatic route of synthesis and patented technology minimise the use of harmful solvents, generate less waste, and reduce the company's carbon footprint by 32% as compared to traditional manufacturers.

The news of the facility expansion follows major milestones on statins that the company reached in the past years. In 2012, under the name of DSM Sinochem Pharmaceuticals, it was the first pharmaceutical manufacturer worldwide to offer generic Atorvastatin APIs under a Certificate of Suitability to the Monograph of the European Pharmacopoeia (CEP). Since 2014, it has produced the unique Atorvastatin APIs in its state–of–the–art facility in Toansa, India for third–party customers.

In addition, the company was one of the first three companies worldwide that started to offer generic Rosuvastatin APIs under CEP in 2016. Two years later, the first generic Rosuvastatin and Atorvastatin finished dosage forms were launched in Western Europe.

"With the doubling of our production capacity, we demonstrate our commitment to maintain our leadership position in line with our strategy and to continue supporting our customers' business growth. Guided by our brand promise of Quality, Reliability, and Sustainability, Centrient's Rosuvastatin and Atorvastatin offer superior performance in all three areas to the benefit of our customers and the environment.", says Frans Vlaar, Chief Commercial Officer at Centrient.

Ground breaking of the new manufacturing unit started at the end of 2019 and commercial supplies from the new unit will start in mid–2021. With the new manufacturing line being operational and doubling the production capacity, Centrient will be even better positioned to secure supply, meeting the growing demand from customers and helping to improve the lives of patients who are in need of these medicine.

"We are extremely proud that we have been able to complete this project in a timely way given the challenges of executing such a complex project in the midst of the COVID pandemic," says Jim McPherson, Chief Quality & Technical Operations Officer. "It reinforces our absolute commitment to meet the expectations of our customers as a partner of choice – delivering reliable and secure supply using leading sustainable technologies. The facility incorporates design features that allow further improvements in GMP and energy utilization, and enable greater automation for improved process control."

—————————————————————————————————————————————————————————————————–


About Centrient Pharmaceuticals

Centrient Pharmaceuticals is the leading manufacturer of beta–lactam antibiotics, and a provider of next generation statins and antifungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.

We stand proudly at the centre of modern healthcare, as a maker of essential and life–saving medicines. With our commitment to Quality, Reliability and Sustainability at the heart of everything we do, our over 2200 employees work continuously to meet our customers' needs. We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.

Founded 150 years ago as the "Nederlandsche Gist– en Spiritusfabriek', our company was known as Gist Brocades and more recently DSM Sinochem Pharmaceuticals. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, Egypt, the United States and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.

For more information please visit www.centrient.com or contact Centrient Pharmaceuticals Corporate Communications, Alice Beijersbergen, Director Branding & Communications. E–Mail: alice.beijersbergen@centrient.com.

Forward–looking statements
This press release may contain forward–looking statements with respect to Centrient Pharmaceuticals' future financial performance and position. Such statements are based on current expectations, estimates and projections of Centrient and information currently available to the company. Centrient cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. Centrient has no obligation to update the statements contained in this press release, unless required by law. The English language version of the press release is governing.


GLOBENEWSWIRE (Distribution ID 8257451)

Centrient Pharmaceuticals to acquire Astral SteriTech, expanding its product portfolio with sterile injectable antibiotic finished dosage forms

Rotterdam, the Netherlands, February 15th, 2021, Feb. 15, 2021 (GLOBE NEWSWIRE) —

  • Further strengthens Centrient Pharmaceuticals' position as the global business–to–business industry leader in beta–lactam antibiotics
  • Broadens Centrient Pharmaceuticals' product portfolio with sterile injectable Semi–Synthetic Cephalosporin and Semi–Synthetic Penicillin finished dosage forms, able to further meet the needs of customers in these segments and become a preferred partner for customers
  • Brings in–house manufacturing capabilities for high–quality sterile antibiotic powder injectable finished dosage forms with two US FDA–approved production lines

Centrient Pharmaceuticals ("Centrient"), the business–to–business leader in sustainable, enzymatic antibiotics, next–generation statins and anti–fungals, today announced the signing of an agreement for the acquisition of Astral SteriTech Private Limited ("Astral SteriTech"), a leading international manufacturer specialised in sterile antibiotic injectable finished dosage forms. With the acquisition of Astral SteriTech, Centrient strengthens its position as the global business–to–business industry leader in beta–lactam antibiotics.

The acquisition of Astral SteriTech is an important step on Centrient's journey to become the leading, diversied and fully integrated partner to generics marketers.

The products offered by Astral SteriTech are sterile injectable finished dosage forms for Semi–Synthetic Cephalosporins and Semi–Synthetic Penicillins. Being close to Centrient's core products of beta–lactam antibiotics, the acquired product portfolio provides Centrient a diversification opportunity within the attractive growing niche segment of sterile injectable antibiotics.

With the broadened product portfolio, Centrient can further meet the needs of its customers in Semi–Synthetic Cephalosporin and Semi–Synthetic Penicillin finished dosage forms and become the preferred partner in these segments.

Astral SteriTech has a US FDA–approved manufacturing site with two manufacturing lines and serves customers in highly regulated markets like the United States and other regions such as South Asia.

The transaction is subject to customary regulatory approvals and closing conditions.

Rex Clements, CEO at Centrient said: "The acquisition of Astral SteriTech is a significant step forward on the journey we at Centrient have undertaken to become the preferred commercial partner to our customers in Semi–Synthetic Cephalosporin and Semi–Synthetic Penicillin antibiotics.

By broadening of our product portfolio and adding advanced manufacturing capabilities, we will strengthen the delivery of our value proposition of Quality, Reliability and Sustainability.

These finished dosage forms are critical medicines in healthcare but face increasing risks of supply shortage. At Centrient, we are committed to ensuring a sustainable supply of these products in healthcare, in line with our purpose to improve lives by being at the centre of sustainable and accessible healthcare."

Dr. Dushyant Patel, Chairman and Managing Director at Astral SteriTech said: "We are proud that with Astral SteriTech's core competencies and proven strong track record in sterile injectable Semi–Synthetic Cephalosporin and Semi–Synthetic Penicillin finished dosage forms, we can contribute to synergize and consolidate Centrient's antibiotics product portfolio, to support their geographical expansion agenda.

Centrient's vision and strategies for global success blended with Astral SteriTech's strong fundamentals in the niche area will not only enhance quality of service to existing clients but will help expand the business horizon."

For the transaction, Barclays acted as the exclusive financial advisor, and Sidley Austin LLP and Trilegal as legal advisors to Centrient Pharmaceuticals. J.P. Morgan acted as the exclusive financial advisor and Shardul Amarchand Mangaldas & Co as legal advisor to Astral SteriTech.

—————————————————————————————————————————————————————————————————–

About Astral SteriTech Private Limited

Astral SteriTech is a leading international contract manufacturer specialized in sterile antibiotic powder injectable finished dosage forms.

Established as Astral Pharmaceutical Industries in 1991 by Dr. Dushyant Patel, current Chairman and Managing Director, and renamed into Astral SteriTech Private Limited in 2012, the company carved its niche as a preferred Contract and Development Manufacturing Organisation in the industry segment of sterile antibiotic injectable formulations. The company has a US FDA–approved manufacturing site with two dedicated manufacturing lines, located in Vadodara, Gujarat, India, and serves customers in high regulated markets like the United States and other regions such as South Asia.

The company's core competencies include advanced aseptic fill and finish technologies and processes, the highest quality standards supported by its robust Quality System, regulatory services along all product development stages, and extensive product development knowledge.

For more information on Astral SteriTech please visit www.astralsteritech.com.

About Centrient Pharmaceuticals

Centrient Pharmaceuticals is the global leader in the production and commercialisation of sustainable antibiotics, next–generation statins and anti–fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.

We stand proudly at the centre of modern healthcare, as a maker of essential and life–saving medicines. With our commitment to Quality, Reliability and Sustainability at the heart of everything we do, our over 2200 employees work continuously to meet our customers' needs. We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.

Founded 150 years ago as the "Nederlandsche Gist– en Spiritusfabriek', our company was known as Gist Brocades and more recently DSM Sinochem Pharmaceuticals. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, Egypt, the United States and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.

For more information please visit www.centrient.com or contact Centrient Pharmaceuticals Corporate Communications, Alice Beijersbergen, Director Branding & Communications. E–Mail: alice.beijersbergen@centrient.com.

Forward–looking statements

This press release may contain forward–looking statements with respect to Centrient Pharmaceuticals' future financial

performance and position. Such statements are based on current expectations, estimates and projections of Centrient and information currently available to the company. Centrient cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. Centrient has no obligation to update the statements contained in this press release, unless required by law. The English language version of the press release is governing.


GLOBENEWSWIRE (Distribution ID 8152934)