CARBOGEN AMCIS opens new state-of-the-art facility dedicated to sterile liquid drug product manufacturing in France

  • Bubendorf, Switzerland (3 February 2023) – Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has opened a state-of-the-art facility in Saint-Beauzire, France.

CARBOGEN AMCIS opens new state-of-the-art facility dedicated to sterile liquid drug product manufacturing in France

Bubendorf, Switzerland (3 February 2023) – Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has opened a state-of-the-art facility in Saint-Beauzire, France.

The new site is dedicated to the custom development and production of sterile injectable drug products. Built on newly acquired land located 7km from an existing CARBOGEN AMCIS site in Riom, the new facility increases product development and manufacturing capacity for liquid and freeze-dried products for pre-clinical and clinical trials as well as small scale commercial use.

CARBOGEN AMCIS has over 15 years’ experience of developing safe injectable and liquid pharmaceutical forms for a wide range of disease areas. Construction started on the new site in January 2021. The facility forms two new fully-automated production lines for liquid and freeze-dried drug products, including highly potent compounds and advanced therapies such as antibody drug conjugates enabling increased customer access. The lines offer a flexible and versatile set up, which is unique within Europe and comes at a time when securing fill finish capacity can be a challenge for many pharmaceutical companies.

Pascal Villemagne, CEO of CARBOGEN AMCIS Group, said: “Over the last six years, CARBOGEN AMCIS has continued to expand our facilities and grow our capacity, enabling us to support more customers and increase access to new and diverse technologies and services.

“Our new site will enable us to fully synergize our world-class chemistry skills and continue to bring our customers’ science to life, helping us play our part in the roll-out of new and better treatments, which help improve patients’ quality of life or treat otherwise terminal illness.”

The 9,500m2 facility will be home to approximately 100 highly-skilled employees and create 50 new jobs throughout 2023.

François Baduel, Vice President of Business Development, Sales & Marketing of CARBOGEN AMCIS Group, said: “The opening of our new site in France signals an exciting time for us as we enhance our capacity to provide seamless drug product development and commercialization services for leading pharmaceutical and biopharmaceutical companies on a global scale.

“Applying state-of-the-art containment technologies, our new site in France cements us as the partner of choice for development and manufacture of drug products.”

CARBOGEN AMCIS’ nine sites across Switzerland, France, the United Kingdom, China and The Netherlands are home to cGMP-compliant, innovative technologies that enable the pharmaceutical and biopharmaceutical industries to bring new generation medicines to market.

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CARBOGEN AMCIS announces successful Swissmedic inspection at Vionnaz, Switzerland

CARBOGEN AMCIS announces successful Swissmedic inspection at Vionnaz, Switzerland

Bubendorf, Switzerland (Septembre 29, 2022) – Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced that its site in Vionnaz, Switzerland has successfully completed a Swissmedic inspection performed by Regional Medicines Inspectorate of Western Switzerland (ISOPTh).

The two-day inspection took place from September 20th to 21th, 2022 and was undertaken by an inspector of Regional Medicines Inspectorate of Western Switzerland (ISOPTh) at the Vionnaz, Switzerland, site. The routine inspection covered the Quality Management System compliance and no critical deviation were raised.

This inspection continues a series of successful inspections by Swissmedic in Vionnaz with the first inspection in 2015 followed by 2016, 2017 and 2020.

“I am very pleased by the positive outcome of the inspection,” said Pascal Villemagne, CEO of CARBOGEN AMCIS. “It’s a great achievement for our Vionnaz site and rewards the constant excellent work and commitment to quality of our dedicated team, maintaining our successful audit history.”

The facility was acquired by CARBOGEN AMCIS in 2014 and is designed to develop and manufacture highly potent active pharmaceutical ingredients (API) including the capability to produce highly potent warheads and linkers for antibody drug conjugates (ADC).


CARBOGEN AMCIS (www.carbogen-amcis.com) is a leading service provider offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries across all stages of clinical development and product life cycle. Our integrated services and innovative chemistry solutions support timely and safe drug development, allowing customers to better optimize available resources. CARBOGEN AMCIS is a wholly owned subsidiary of Dishman Carbogen Amcis Limited, Ahmedabad, India. 

Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

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CARBOGEN AMCIS AG Makes Capital Investments in ADC

  • Switzerland-based CARBOGEN AMCIS AG announces a series of significant investments aimed at enhancing its antibody drug conjugate (ADC) capabilities to better respond to increasing demand for ADCs in the development of highly targeted cancer treatments. The investments include a $4 million USD clean room clinical supply facility at the Bubendorf, Switzerland site and a $950,000 USD upgrade of the sterile manufacturing area at the facility in Riom, France. By adding on to the current High Potency facility, CARBOGEN AMCIS is well positioned to offer its partners seamless development and manufacturing services for ADCs.

CARBOGEN AMCIS AG Makes Capital Investments in ADC

Switzerland-based CARBOGEN AMCIS AG announces a series of significant investments aimed at enhancing its antibody drug conjugate (ADC) capabilities to better respond to increasing demand for ADCs in the development of highly targeted cancer treatments. The investments include a $4 million USD clean room clinical supply facility at the Bubendorf, Switzerland site and a $950,000 USD upgrade of the sterile manufacturing area at the facility in Riom, France. By adding on to the current High Potency facility, CARBOGEN AMCIS is well positioned to offer its partners seamless development and manufacturing services for ADCs.

“The new targeted cancer treatments, such as Adcetris, Kadcyla and Mylotarg, have fueled a growing demand for ADCs and we made the decision to expand our ADC service offer to support customers in the development of next-generation cancer treatments. We have taken into account customer feedback and market dynamics and are confident that our enhanced infrastructure will enable us to provide our partners in the pharmaceutical industry a needed resource in drug development,” said Mark C. Griffiths, CEO, CARBOGEN AMCIS and the Dishman Group.

The Bubendorf facility now features a new 100-sqm ADC clean room suite dedicated to the development and production of ADC clinical material under current good manufacturing practices (cGMP), and contains grade D and grade C areas to allow aseptic and safe handling of highly potent material at occupational exposure limit values (OELs) below 1 µg/m3 at 8-hour time weighted average (8h-TWA). A system of pressure cascade and air locks for material and personnel fully segregates both areas of the clean room from the rest of the building and ensures sterile operations within both compartments.

The grade D area of the lab is dedicated to operations such as the preparation of reagents and buffers as well as the sterilization of production equipment by dry oven or autoclave. The segregated grade C area is exclusively used for the conjugation, the purification, and the packaging of ADC material under cGMP and features (a) an isolator for the preparation of toxin solutions, (b) a barrier system for aseptic filtration, (c) a walk-in fume hood for handling of organic solvents, and (d) a bio-safety cabinet (classified grade C) for antibodies and ADCs.

The upgrades at our Riom, France location include the implementation of a new vaporized hydrogen peroxide (VHP) disinfection system and the installation of two new aseptic filling isolators operating under nitrogen atmosphere and at regulated temperature, which will expand the Grade A (ISO 5) manufacturing capability at OELs below 1 µg/m3 8h-TWA, allowing a maximum batch size up to 5’000 units (2 mL vials).

“In addition to strengthening our ADC capabilities, over the past 12 months, we have built a cross-functional team with expertise in chemistry, biochemistry and biology that is well equipped to support our customers’ cancer drug development programmes,” added Griffiths. Dr. Scott Miller, head of special projects, a chemist with over 19 years industry experience in the commercialization of oncology drugs, will lead CARBOGEN AMCIS ADC team and will support customers involved in ADC projects.

As major oncology players focus on ADCs as a high-potential opportunity in the development of targeted cancer therapies, CARBOGEN AMCIS offers a valuable outsourcing solution for the complex process of ADC development.

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a member of the Dishman Group based in Ahmedabad,India.

Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

Source: CARBOGEN AMCIS AG,Bubendorf,>Switzerland

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CARBOGEN AMCIS AG Continues to Invest in Expanding High Potency Capabilities

  • To meet rising demand for highly potent active pharmaceutical ingredients (APIs) spurred by the growing targeted therapy approach in the treatment of diseases, in particular oncology, Switzerland-based CARBOGEN AMCIS AG today announced that it has completed a capital investment project to upgrade its high potency capabilities.

CARBOGEN AMCIS AG Continues to Invest in Expanding High Potency Capabilities

To meet rising demand for highly potent active pharmaceutical ingredients (APIs) spurred by the growing targeted therapy approach in the treatment of diseases, in particular oncology, Switzerland-based CARBOGEN AMCIS AG today announced that it has completed a capital investment project to upgrade its high potency capabilities. An industry leader in the production of high potency APIs, CARBOGEN AMCIS offers drug developers the full range of high potency services, from development, manufacturing and chromatography, to antibody drug conjugates (ADCs), fill & finish, lyophilization, and life-cycle management.

The enhancements will include: 

  • A dedicated chromatography suite for Category 3 and 4 compounds at its niche-scale commercial facility for highly potent APIs in Bubendorf, Switzerland. The 55-sqm grade D area features three walk-in barrier hoods for safe handling of highly potent material and a 15 cm ID high performance liquid chromatography (HPLC) column for the purification of highly potent APIs in the range of 50 - 500 g/day.
  • A new Class 100,000 High Potency Kilo-lab with 110-sqm of floor space at its large-scale commercial facility for highly potent APIs in Bavla, India. The Kilo-lab features multiple glass-lined and stainless steel reactors and agitated nutsche filter driers (ANFDs) equipped with charging/discharging isolators. A negative pressure cascade and the high-efficiency particulate air (HEPA) filters allow the safe production of highly potent APIs at exposure limit values (OELs) between 1 μg/m³ and 50 ng/m³ at 8-hour time weighted average.

“The expansions in India and Switzerland continue CARBOGEN AMCIS’ investment in building out a global, high potency platform to meet the growing demand for high potency APIs for oncology applications. This move, along with parallel investments in the ADC arena in France and Switzerland, is a reflection of CARBOGEN AMCIS’ continued commitment to providing a broad range of personalized, expert services, capabilities and geographic choices to our clients to help them develop the next-generation cancer treatments,” commented Mark C. Griffiths, CEO, CARBOGEN AMCIS and the Dishman Group.

Choosing the right outsourcing partner for the development and manufacture of high potency APIs is a critical consideration for pharmaceutical companies who seek partners with expertise in chemistry, cutting-edge containment engineering technology and risk reduction in the handling of highly potent cytotoxic drugs. Since 2003, high potency APIs have been a core specialization for CARBOGEN AMCIS and the recent investments underscore the company’s commitment to offering strong technical expertise in the development and commercialization of New Chemical Entities (NCEs) and APIs, which resulted in the launch of more than 12 commercial products worldwide.

Thanks to its state-of-the-art R&D and manufacturing infrastructure and expertise in high potency APIs, CARBOGEN AMCIS is well positioned to contribute to the development of next-generation cancer treatments and other therapies.

About CARBOGEN AMCIS High Potency Facilities:

The Bubendorf facility was opened in 1987 and has seen a number of additions in its more than 20-year history. The manufacturing building was commissioned in 1996 and the lab, administration and containment facilities were opened in 2005. The site now supports over 180 employees, who focus on process optimization and supply of late-phase and commercial API supplies. 

The Bavla facility complements the Bubendorf high potency facility. The plant is one of the largest, extensive and flexible custom-manufacture high potency facilities in the world and enables customers to work with CARBOGEN AMCIS from early-stage route development to market supply without volume limitations. The Bavla facility caters to both cytotoxic and non-cytotoxic highly active substances in dedicated areas.

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a member of the Dishman Group based in Ahmedabad, India.

Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland

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CARBOGEN AMCIS Expands Operations in Switzerland

  • CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced plans to take over operations of a high-containment facility located in Vionnaz, Switzerland, 70 kilometers East of Geneva

CARBOGEN AMCIS Expands Operations in Switzerland

CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced plans to take over operations of a high-containment facility located in Vionnaz, Switzerland, 70 kilometers East of Geneva:

CARBOGEN AMCIS │ Route du Simplon 24 │ CH-1895 Vionnaz │ Switzerland

The high potency facility in Vionnaz opened in December 2005 and was formerly managed by Bachem AG as an integrated part of their site in Vionnaz. Designed to operate at OEL < 0.1μg/m3 8h-TWA, the unit is cGMP-compliant and inspected by Swissmedic and by the U.S. Food and Drug Administration (FDA). Effective today, CARBOGEN AMCIS has signed an agreement to officially take over control of this unit. Operations are slated to start later this fall.

“We are facing a significant increase in the demand for high potency services, spurred by the fast-paced growth of the Antibody Drug Conjugates (ADCs) market. The expansion in Vionnaz will ensure we can continue to fulfill customer needs and expectations while our company continues to grow and expand.” commented Mark Griffiths, CEO CARBOGEN AMCIS. “Our partners will benefit from additional high potency capabilities available at the Vionnaz facility such as high potency laboratories, cGMP kilo-scale manufacturing, as well as larger scale lyophilisation.”

The Vionnaz unit is dedicated to the development and manufacture of highly potent APIs and can accommodate projects from gram to multi-kilo scale. The facility is completely independent and features a process development laboratory, a dedicated QC laboratory and two production units fitted with reactors up to 30 L, as well as a freeze dryer for lyophilisation and chromatography. Operations involving cytotoxic compounds are performed under containment conditions in line with CARBOGEN AMCIS’ standards of safety and quality. The building is self-contained and segregated from the outside. All laboratories from gram to kilo-scale production are cGMP compliant.

The substantial increase in development capabilities and manufacturing space for highly potent drugs in Vionnaz, along with the recent construction of a clean room dedicated to conjugation projects in Bubendorf, positions CARBOGEN AMCIS as industry leader and outsourcing partner for complex highly potent APIs and ADCs. In the near future, the company plans to introduce additional capability for highly potent drugs at the Neuland (Hunzenschwil) site to meet customer needs in chemical development and niche commercial manufacturing.

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India. 

Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

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CARBOGEN AMCIS CEO Mark Griffiths Appointed to Dishman Board of Directors

  • CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced that Mark C. Griffiths, global chief executive officer of Dishman and CARBOGEN AMCIS, has joined the board of directors of Dishman Pharmaceuticals and Chemicals Ltd.

CARBOGEN AMCIS CEO Mark Griffiths Appointed to Dishman Board of Directors

CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced that Mark C. Griffiths, global chief executive officer of Dishman and CARBOGEN AMCIS, has joined the board of directors of Dishman Pharmaceuticals and Chemicals Ltd.

The appointment was made public by Shri Arpit J. Vyas, managing director,Dishman Pharmaceuticals and Chemicals Ltd.“We are excited to welcome Mark to the board of Dishman. Mark’s leadership at the helm of CARBOGEN AMCIS has turned the company into a success story in the pharmaceutical industry, leading to an increase in business from 63 to 100 million CHF since his appointment. We look forward to a path of continued success together,” said Vyas. Griffiths has served as chief executive officer since 2011 and has been associated with CARBOGEN AMCIS as director of operations and chief executive officer for almost ten years. He also worked for the Dishman Group as operations advisor overseeing the design and construction of the group’s large-scale manufacturing facilities for commercial supply of Highly Potent APIs (HPAPIs) in Shanghai, China, and Ahmedabad, India.

Griffiths has over 31 years of relevant industrial experience delivering high added value technical and operational solutions within the pharmaceutical and fine chemical industry. Qualified as an engineer and having gained significant experience in the management of complex, multi-task, multi-input projects, he brings a cross-functional ability to anticipate and optimize technical, operational and management issues. Griffiths has designed, built and managed facilities ranging in function from research and development to manufacturing. Griffiths holds a Master of Science in engineering from Bristol University, UK.

Dishman is a leading global outsourcing partner for the pharmaceutical industry, offering a rich portfolio of development, scale-up and manufacturing services that straddle the entire pharmaceutical value chain. The company offers cost-effective, high-quality research, development and manufacturing services that include production and supply of tailor-made, high-quality Intermediates and generic APIs to the global pharmaceutical industry. Its global presence includes multiple manufacturing sites in Europe, India, and China – making it one of the most geographically diversified players in the industry.

The Dishman board of directors consists of Shri Janmejay R. Vyas, Chairman & Managing Director; Mrs. Deohooti J. Vyas, Whole-Time Director; Shri Arpit J. Vyas, Managing Director; Shri Yagneshkumar B. Desai, Director; Shri Sanjay S. Majmudar, Director; and Shri Ashok C. Gandhi, Director.

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India. 

Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

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CARBOGEN AMCIS Passes Successful Inspection by Swissmedic

  • CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced a successful inspection by Swissmedic of its recently acquired site in Vionnaz, Switzerland.

CARBOGEN AMCIS Passes Successful Inspection by Swissmedic

CARBOGEN AMCIS, the Swiss-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced a successful inspection by Swissmedic of its recently acquired site in Vionnaz, Switzerland.

The site has been inspected by Swissmedic and by the U.S. Food and Drug Administration (FDA) in the past and the re-audit is due to the change of ownership. The two-and-a-half-day audit covered the Quality System related to development and manufacture of highly potent APIs at the Vionnaz facility, including Analytical and Quality Control. This is the first stage in the facility’s cGMP certification process, which should be completed in the next two months.

The high potency facility in Vionnaz is designed to operate at an occupational exposure limit (OEL) level down to 0.05μg/m3. CARBOGEN AMCIS acquired the facility in August 2014 to significantly increase the development and manufacturing capacity of highly potent APIs. This site has already demonstrated the capability to produce highly potent warheads and linkers, which can be transferred to our bio conjugation facility in Switzerland to create Antibody Drug conjugates (ADC) for cancer treatment therapy.

"The positive conclusion of this inspection demonstrates our commitment to the highest standards of quality across all of CARBOGEN AMCIS’ facilities,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS. "We acquired this site last year and, with the support of our expert groups in Switzerland, the Vionnaz team has been able to demonstrate to Swissmedic that CARBOGEN AMCIS meets all aspects of quality to supply our customers with GMP API’s from the facility. This continues our long track record of successful regulatory audits.”

“My team on-site is highly qualified with more than 10 years of experience in manufacturing highly potent APIs. Combined with our 15 years of expertise at CARBOGEN AMCIS, we managed to create really attractive synergies,” said Rolf Tunnemann, Director of CARBOGEN AMCIS Vionnaz facility. “As we move forward, we will continue to pursue opportunities to improve quality. We now have to follow the process and validate cGMP certification in the next few months.”

“I am proud of what our team has achieved in such a short length of time and delighted that we will be able to continue to support our clients growing needs,” commented Mark Griffiths, CEO, CARBOGEN AMCIS and the Dishman Group.

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India.  

Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.

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CARBOGEN AMCIS Expands Operations in Bubendorf

  • BUBENDORF, Switzerland (May 31st, 2016) — CARBOGEN AMCIS, the Swiss-based company offering process development and manufacturing of Active Pharmaceutical Ingredient (API) to the pharmaceutical industry, has announced the extension of its operations in Bubendorf.

CARBOGEN AMCIS Expands Operations in Bubendorf

BUBENDORF, Switzerland (May 31st, 2016) — CARBOGEN AMCIS, the Swiss-based company offering process development and manufacturing of Active Pharmaceutical Ingredient (API) to the pharmaceutical industry, has announced the extension of its operations in Bubendorf.
 
On May 26th, 2016, we (CARBOGEN AMCIS) have undersigned the acquisition of the land and buildings of GEA Pharma Systems AG in Bubendorf, Hauptstrasse 145. The acquisition close to our current headquarters will become effective on Jan. 1st, 2017.
 
Located on 5’200 m² of land, the 3360 m2 multi-story building is divided into laboratory, production, storage and office areas and provides a set of clean-room GMP compliant suites. We are planning modification work in order to adapt the building to our specific requirements and convert more of the facility into GMP operations areas.
 
“The immediate proximity to our current headquarters and our larger scale production site in Bubendorf, Switzerland, is ideal. It will allow us to significantly extend our laboratory capacity for highly potent development and small scale production as well as analytical support.” said Stephan Fritschi, Vice-President Operations at CARBOGEN AMCIS. “Operations are scheduled to expand into the new building in 2017”.
 
“In the last couple of years we have experienced a significant and continuous increase in customers’ demand for additional capacity, including demand for labs and small scale development.” said Mr Janmejay Vyas, Chairman of the Dishman Group of Companies. “This acquisition is targeted to support our business growth and company expansion. It will allow CARBOGEN AMCIS to keep its position as an industry leader and outsourcing partner for complex highly potent APIs and ADCs”.
 
“I am delighted that we are able to extend our operations in Bubendorf in order to fulfil our customer needs and their growing expectations.” Commented Mark Griffiths, Global CEO of CARBOGEN AMCIS and the Dishman Group. “Moreover, this facility will bring new opportunities to further enhance our capabilities and capacities. In the near future, the company plans to introduce a number of additional capabilities including, but not limited to, commercial manufacture of ADC’s and additional Cat 4 (ng OEL) development capacity. The new facility is closely located with our current CARBOGEN AMCIS Headquarters in Bubendorf and as such enables us to leverage the existing support network to the new site"
 

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India. 
 
Dishman Pharmaceuticals and Chemicals Ltd (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. The Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

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CARBOGEN AMCIS Sites at Aarau and Neuland in Switzerland Successfully Pass FDA Inspection

  • BUBENDORF, Switzerland (July 13th, 2016) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced, after reception of the Establishment Inspection Report (EIR), that two of its Swiss sites have successfully completed a U.S. Food and Drug Administration (FDA) inspection.

CARBOGEN AMCIS Sites at Aarau and Neuland in Switzerland Successfully Pass FDA Inspection

BUBENDORF, Switzerland (July 13th, 2016) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced, after reception of the Establishment Inspection Report (EIR), that two of its Swiss sites have successfully completed a U.S. Food and Drug Administration (FDA) inspection.

The Pre-Approval Inspections (PAIs) have been completed by an FDA inspector over four days: October 19-20, 2015 in Aarau and October 21 – 22, 2015 in Neuland. The inspections have been concluded with no Form 483 observations or major critical findings, thus confirming that no concerns were discovered during the inspection. The Establishment Inspection Report, received on July 13th, 2016, confirmed this conclusion.

“The successful inspection at the Aarau and Neuland sites underscores CARBOGEN AMICS’ track record of high quality development and manufacturing. These inspections follow a series of successful FDA inspections at our sites. Our Headquarters in Bubendorf have also been successfully inspected by the FDA in 2002, 2008, 2011 and 2014. We have again established the Dishman group’s commitment to consistently fulfill the highest quality requirements for all its sites,” commented Mark Griffiths, CEO Dishman Group. “Our quality team is working closely with every CARBOGEN AMCIS facility to build and reinforce a dependable and strong quality policy across the company.”

“I am delighted about this positive report from the FDA,” said Mr J.R. Vyas, Chairman of the Dishman Group. “This is a great result, which rewards all efforts from our team to maintain the highest level of quality. This also shows our commitment to meet and exceed our customers’ expectations. Since we know that the highest quality standards are essential, we will be well positioned to continue to support our customers’ needs.”

The Aarau and Neuland facilities have the flexibility to accommodate any project, be it API or analytical. They are located 10km away of each other and constitute a team of more than 200 employees. 
-    Total of 30 vessels from 10 L to 640 L
-    Swiss Medic approved sites
-    Fully cGMP compliant
-    Specialized Chromatography Group
-    Strong Analytical Capabilities & Specialties Lab
-    Across all Site spanning Hazard & Safety Lab

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India.  

Dishman Pharmaceuticals and Chemicals Ltd (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

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Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS

  • AHMEDABAD, INDIA, August 11, 2016 – Dishman Pharmaceuticals and Chemicals Ltd (DPCL), leading outsourcing partner for the global pharmaceutical industry, today marked the 10-year anniversary of its acquisition of CARBOGEN AMCIS. A significant milestone of growth and development of Indian-Swiss business relations.

Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS

AHMEDABAD, INDIA, August 11, 2016 – Dishman Pharmaceuticals and Chemicals Ltd (DPCL), leading outsourcing partner for the global pharmaceutical industry, today marked the 10-year anniversary of its acquisition of CARBOGEN AMCIS. A significant milestone of growth and development of Indian-Swiss business relations.
 
CARBOGEN AMCIS (headquarters in Bubendorf, Switzerland) and Dishman Pharmaceuticals and Chemicals Ltd (headquarters in Ahmedabad, India) are both suppliers of complex services and products for the global pharmaceutical industry. In addition, each company belongs to the high-tech end of their country’s respective field.

“The acquisition by the Dishman Group of two pharmaceutical businesses from the company formerly known as Solutia Europe, which together formed CARBOGEN AMCIS, is a brilliant example of the impressive achievements companies can make through collaboration,” said Mark Griffiths, CEO, Dishman Group. “I am very proud of all our employees’ contributions to a decade of not only team work and business relationships, but also the sharing of cultures between India and Switzerland.”

More than 380 official representatives, customers, business partners, investors and employees will gather to celebrate this success during a Fusion event in Bubendorf on August 11, 2016. 
 
A portion of the ceremony will pay tribute to Mr. J.R. Vyas, Chairman, Owner of the Dishman Group and Founder of Dishman Pharmaceuticals and Chemicals Ltd.

“The ceremony gives us an opportunity to thank Mr. Vyas for his 10-year contribution to the success of this collaboration,” said Griffiths. “His achievement in seamlessly bringing two cultures together is remarkable, and I look forward to watching him lead Dishman Group into further growth and expansion for years to come.”

“Loyal clients, consistent quality confirmed through numerous successful audits by international regulators, as well as further planned expansions make a bright future for Dishman Group,” commented Mr. Vyas. “I am honoured to play a role in continuing to build a positive outlook for Indian-Swiss collaborative business ventures.”

Since 2006, both companies have played crucial roles for the group’s growth. The Dishman Manchester site was successfully integrated into CARBOGEN AMCIS in 2007, followed by the integration of the Shanghai site in 2015. CARBOGEN AMCIS’ footprint and capacity expanded through additional site acquisitions (Riom, France in 2012; Vionnaz, Switzerland in 2014) and the recently announced facility expansion in Bubendorf through the acquisition of land and buildings of GEA Pharma Systems AG. 

Today, the multi-million dollars service provider operates ten sites (two in India, one in Netherlands, four in Switzerland, one in the United Kingdom, one in France, and one in China), employing more than two thousand employees, and records a highly successful audit history.

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd, Ahmedabad, India. 
 
Dishman Pharmaceuticals and Chemicals Ltd (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. The Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

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CARBOGEN AMCIS Sites at Bubendorf, Aarau and Neuland in Switzerland Successfully Pass Swissmedic Inspection

  • BUBENDORF, Switzerland (July 21st, 2017) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced the renewal of cGMP certificates, and the successful completion of Swissmedic inspections at three of its sites.

CARBOGEN AMCIS Sites at Bubendorf, Aarau and Neuland in Switzerland Successfully Pass Swissmedic Inspection

BUBENDORF, Switzerland (July 21st, 2017) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced the renewal of cGMP certificates, and the successful completion of Swissmedic inspections at three of its sites. 

Swissmedic conducted inspections (general surveillance audits) of three of CARBOGEN AMCIS' facilities – Bubendorf, Aarau and Neuland – in late April and early May, 2017. No significant concerns were discovered during the inspections which resulted in the renewal of the GMP-certificates, granted for all three sites.

"The successful inspections of the Bubendorf, Aarau and Neuland facilities reinforce our commitment to the highest quality standard in Switzerland and worldwide,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS. “The three facilities meet all expectations related to cGMP and quality for API development and manufacturing services to support our customers. We are extremely pleased to continue our long-standing track record of successful inspections and regulatory audits.”

 “Our company is continuously growing and expanding its operations, particularly at our facilities in Bubendorf, Aarau and Neuland. A positive audit is a critical component of our expansion process. We remain deeply committed to excellence, so quality is crucial to our success and our customer's satisfaction," said Mark Griffiths, CEO, Dishman Group. 

Bubendorf 
Operating since 1987, the Bubendorf facility is CARBOGEN AMCIS’ headquarters. The site employs more than 250 people. Site information at-a-glance:

  • More than 30 vessels from 1 L to 2500L
  • FDA inspected
  • State of the Art ADC Laboratories
  • HiPo manufacturing up to 100 kg scale, up to Cat. 4
  • cGMP Chromatography to multi 100 kg scale
  • Late Phase and Commercial Supply of API


Aarau and Neuland facilities
The Aarau and Neuland facilities have the flexibility to accommodate any project, be it API or analytical. They are located 10km away from each other and constitute a team of more than 200 employees. Site information at-a-glance:
More than 30 vessels from 10 L to 630 L

  • FDA inspected
  • Fully cGMP compliant
  • Specialized Chromatography Group
  • Strong Analytical Capabilities and Specialties Lab
  • Across all Site spanning Hazard and Safety Lab


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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.  

Dishman Carbogen Amcis Limited (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

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CARBOGEN AMCIS Announces a Successful FDA Inspection of its Headquarters Site in Bubendorf, Switzerland

  • BUBENDORF, Switzerland (October 11th, 2017) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Bubendorf, Switzerland API manufacturing site has successfully completed a routine U.S. Food and Drug Administration (FDA) inspection.

CARBOGEN AMCIS Announces a Successful FDA Inspection of its Headquarters Site in Bubendorf, Switzerland

BUBENDORF, Switzerland (October 11th, 2017) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Bubendorf, Switzerland API manufacturing site has successfully completed a routine U.S. Food and Drug Administration (FDA) inspection.

The cGMP (current Good Manufacturing Practices) Audit was completed over five days, from September 4th to 8th, 2017. The inspection consisted of an analysis of all Quality Systems, processes and procedures related to the development, validation and manufacture of APIs and highly-potent APIs at the Bubendorf site. The inspection was concluded without major or critical observations or Form 483’s, thus confirming that no concerns were discovered during the inspection. The Final Establishment Inspection Report (EIR) is expected in the next six months.

“The successful FDA inspection of our Bubendorf site, proceeded by two successful inspections of our two other sites in Aarau and Neuland in 2015, reinforces CARBOGEN AMCIS’ commitment to delivering the highest standard of quality that our customers expect from us” said Mark Griffiths, CEO Dishman Group. “We look forward to sharing this exciting news with our customers at CPhI on October 24-26, 2017, in Frankfurt, Germany.”

“I am delighted about this positive outcome of the FDA inspection at Bubendorf,” said Mr. J.R. Vyas, Chairman and Founder of the Dishman Group. “This is a great achievement that rewards many years of dedication and commitment to quality by each of our team members, thus maintaining our long track record of successful regulatory inspections and audits.”  

The Bubendorf facility manufactures products according to cGMP standards and is routinely inspected by SwissMedic, the FDA and external customers. The facility underwent successful FDA inspections in 2002, 2008, 2011 and 2014.

Operating since 1987, the Bubendorf facility is CARBOGEN AMCIS’ headquarters. The site employs more than 250 people. Site information at-a-glance:
•    More than 30 reactors from 1 L to 2500L
•    FDA and Swiss Medic inspected
•    State of the Art ADC Laboratories
•    HiPo manufacturing up to 100 kg scale, up to Cat. 4+
•    cGMP Chromatography to multi 100 kg scale
•    Late Phase and Commercial Supply of API

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.  

Dishman Carbogen Amcis Limited (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

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CARBOGEN AMCIS Announces a Successful Swissmedic Inspection of its Site in Vionnaz, Switzerland

  • BUBENDORF, Switzerland (February 16, 2018) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Vionnaz site has successfully completed a Swissmedic inspection.

CARBOGEN AMCIS Announces a Successful Swissmedic Inspection of its Site in Vionnaz, Switzerland

BUBENDORF, Switzerland (February 16, 2018) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Vionnaz site has successfully completed a Swissmedic inspection.

Swissmedic conducted the inspection (general surveillance audits) over two days, on December 12-13, 2017 at CARBOGEN AMCIS’ Vionnaz site. The inspection covered the Quality System related to the development and manufacture of highly potent APIs, including Analytical and Quality Control. No significant concerns were discovered during the inspection, which will result in the renewal of the GMP-certificates for the site.

The high potency facility in Vionnaz is designed to operate at an occupational exposure limit (OEL) level down to 0.05μg/m3. CARBOGEN AMCIS acquired the facility in August 2014 to significantly increase the development and manufacturing capacity of highly potent APIs. This site has already demonstrated the capability to produce highly potent warheads and linkers, which can be transferred to our bio conjugation facility in Switzerland to create Antibody Drug conjugates (ADC) for cancer treatment therapy.

 “This inspection follows the first audit by Swissmedic in 2016 for the cGMP certification after we acquired this site,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS. “This successful inspection underscores CARBOGEN AMICS’ track record of high quality development and manufacturing. Our other facilities in Switzerland also successfully passed a series of audits last year; FDA audit in October 2017 for the Bubendorf (Headquarters) and Swissmedic inspections for the sites in Bubendorf, Neuland and Aarau in July 2017. This proves our commitment to consistently fulfill the highest quality requirements for all of our sites”.

 “I am proud of what the Vionnaz team has been able to achieve with support by our expert groups in Switzerland. Demonstrating to Swissmedic its capacity to meet all aspects of quality is a significant accomplishment,” said Mark Griffiths, CEO, Dishman Carbogen Amcis group. “This facility was acquired more than 3 years ago to extend our Antibody Drug Conjugate Services and increase the development and manufacturing capacity of highly potent APIs. I am delighted of this successful integration that meets the constantly growing demand of our customers.”

 ****

 CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.  

Dishman Carbogen Amcis Limited (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 

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Dishman Carbogen Amcis Opens Office in Kyoto, Japan

  • BUBENDORF, Switzerland (August 1st, 2018) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today the opening of their new Japanese office, located in Kyoto.

Dishman Carbogen Amcis Opens Office in Kyoto, Japan

BUBENDORF, Switzerland (August 1st, 2018) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today the opening of their new Japanese office, located in Kyoto. 

The opening of Dishman Carbogen Amcis Japan Ltd. marks yet another stepping stone for Dishman Carbogen Amcis, already actively serving the Japanese market for active pharmaceutical ingredients (APIs) development and commercialization services through its Swiss entity CARBOGEN AMCIS AG.

The new office is part of the company’s commitment to increase its presence in Japan and later in other Asia-Pacific markets. “The Japanese market is expanding and we face a growing demand from Japanese customers. Having a local presence will help to bring new opportunities and support the existing business more closely,” said Pascal Villemagne, Vice President, sales & marketing. “This new office will allow us to strengthen our existing customer relationships and help them understand our full capabilities - enabling more business opportunities and future growth.”

Dishman Carbogen Amcis Japan Ltd. starts its activity today with the relocation of one staff member from Switzerland. “My mission is to establish Dishman Carbogen Amcis Japan Ltd. and start up all business activities in the local office. I am thrilled to participate to this new opening.” said Paul Kuad, Sales Manager for the Japan territory. “The team will grow in the coming weeks as we hire local resources to support the sales team.”

“We recognize that Japan plays a critical role in today’s Pharmaceutical Industry and we want to demonstrate to our customers that we value our collaborations. Opening a Japanese office will allow us to better serve our customers and strengthen our local relationships,” said Mark Griffiths, Dishman Carbogen Amcis Group CEO. “In addition, the office will represent a strong advantage to further expand our business development aspirations in the Asia-Pacific arena.”

Japan office details:

Dishman Carbogen Amcis Japan Ltd.
KRP Building no. 4, 3rd floor
Chudoji Awatacho 93, Shimogyo-ku
Kyoto 600-8815
Japan

+81-75-315-9305

****

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited, Ahmedabad, India.       

Dishman Carbogen Amcis Limited (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

 

 

ブーベンドルフ、スイス201881日)スイスに本社を置カーボゲン・アムシス社は、医薬品のプロセス開発や高活性医薬品原体API)の製造に携わっています。この度、京都オフィスを開設する運びとなりましたので、以下の通りお知らせいたします。

 

スイスの子会社カーボゲン・アムシス社の高活性医薬品原体(APIs)の開発や商業生産を通じ、ディシュマン・カーボゲン・アムシス社は日本市場でもすでに活発に事業を展開してきました。そしてこの度、ディシュマン・カーボゲン・アムシス・ジャパン社を創設し、新たな踏み台を築くこととなりました。

新オフィスの開設は、日本、そして将来はアジア・太平洋地域の他の市場においてもプレゼンス強化を目指す、当社のコミットメントの表れです。営業バイスプレジデントのパスカル・ヴィルマーニュは、これについて次のように述べています。「日本市場は拡大しており、日本の顧客からの要望も増えています。現地にオフィスを置くことで新しい可能性が開け、既存事業のより入念なサポートも可能になります。また既存の顧客関係の強化を図り、当社の能力を最大限に活用していただくこともできます。こうして皆様の事業の可能性をさらに引き出し、より一層の成長に貢献できると期待しています」

ディシュマン・カーボゲン・アムシス・ジャパン社は本日、スイスから転任したスタッフ1名を迎え、運営を開始します。日本担当販売マネージャのポール・クアドは次のように語っています。「私の任務はディシュマン・カーボゲン・アムシス・ジャパン社を創設し、現地オフィスが担うべきすべての事業を開始することです。オフィスの新設にかかわることができ、まさに心躍る毎日です。数週間以内に販売チームのサポートをしてくれる人材を現地で採用し、チームを大きくしていく予定です」

また、ディシュマン・カーボゲン・アムシス・グループのマーク・グリフィスCEOも次のように述べています。「日本は今日、薬品業界において重要な役割を担っています。このことをはっきりと認識した上で、当社はこのような協力関係を高く評価し、そのことを顧客に示したいと思っています。日本オフィスの新設で当社の顧客サービスが向上し、日本との関係も強化されることでしょう。このオフィスはまた、アジア・太平洋地域の事業開発にさらに意欲的に取り組むための有力なアドバンテージともなるはずです」

日本オフィスの住所:

ディシュマン・カーボゲン・アムシス・ジャパン社
〒600-8815

京都市下京区中堂寺粟田町93

KRP4号館3階
電話075-315-9305

 ****

カーボゲン・アムシス社(www.carbogen-amcis.com)は、医薬品開発から商業生産まであらゆる段階に求められる各種のサービスを製薬業界およびバイオ医薬品業界に提供するリーディングカンパニーです。当社の統合サービスは、安全で時機を得た医薬品開発を支援する革新的な化学ソリューションを提供しており、お客様は利用可能なリソースを最大限に活用することができます。カーボゲン・アムシス社は、インドのアーメダバードを本拠地とするディシュマン・カーボゲン・アムシス社の子会社です。

ディシュマン・カーボゲン・アムシス社(www.dishmangroup.com)は、開発、スケールアップ、製造などのサービスを医薬品業界に提供するグローバルなアウトソーシングパートナーです。ディシュマン・カーボゲン・アムシス・グループは、欧州各地およびインドにて幅広い開発・製造ソリューションを提供し、顧客の事業改善に貢献しています。

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ISO22716 Cosmetics GMP standard accreditation

  • BUBENDORF, Switzerland (May 22nd, 2019) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Manchester site successfully passed the accreditation for the ISO22716 Cosmetics GMP standard.

ISO22716 Cosmetics GMP standard accreditation

BUBENDORF, Switzerland (May 22nd, 2019) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Manchester site successfully passed the accreditation for the ISO22716 Cosmetics GMP standard. 

CARBOGEN AMCIS Ltd (Manchester) successfully passed two stages of audit in December 2018 and in March 2019 by a third-party certification body conducted by Lloyd's Register Quality Assurance Limited. The audit sessions were to assess the compliance of the Quality Management System of CARBOGEN AMCIS Ltd against ISO 22716:2007.

The new accreditation solidifies the Manchester site capabilities for cosmetic ingredient development and production, allowing for production, control, storage and shipment of active ingredients for skin cream cosmetic products.

“CARBOGEN AMCIS Ltd has been developing and manufacturing cosmetic ingredients for over 20 years. We have a dozen cosmetic ingredients in development and/or production,” said Mark Griffiths, CEO, Dishman Group. “CARBOGEN AMCIS Ltd has a portfolio of cosmetic ingredients and the decision to implement the standard was to provide a Quality Management System to support the current and future cosmetic ingredients portfolio. Moreover, it will provide the basis for all of the products manufactured at the Manchester site and is not restricted to only cosmetic ingredients.”

“Our team was fully committed to successfully achieving this accreditation. The work involved the co-ordination of all departments across the site to implement the requirements of the standard,” said Ian Burley, Director ESQ. “We took a number of steps to meet the accreditation standard’s requirements, such as: gap analysis audits from external companies including CARBOGEN AMCIS AG Switzerland (Mother Company), training for key personnel and workshops. In addition, we have arranged specific external training for staff to ensure internal audits are conducted correctly and in a consistent manner,” added Ian Burley.

“This certification process is integrated in our commitment for continuous quality made by CARBOGEN AMCIS group in order to provide full customer satisfaction and safety by ensuring the quality of the production, storage and shipment of products,” said Robert Rhodes, Manchester Site Director/Director Technical Operations. “In order to maintain the standard, we will be audited every 6 months to ensure compliance is met.”

Manchester’s facility is fully integrated into the in-house supply chain for complex APIs. With over 30 years of experience, the site employs approximately 80 people. Site information at-a-glance:

  • Process research and custom synthesis of pharmaceutical intermediates, cosmetic ingredients and fine chemicals
  • 30 L to 4500 L reactors, cryogenic up to 3000 L
  • Production of early-phase APIs and large-scale intermediates
  • 50% of technical staff hold Ph.D. qualifications
  • > 100 projects per annum
  • In-house technologies to support different types of chemistry
  • Analytical laboratories and safety lab

****

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited, Ahmedabad, India.       

Dishman Carbogen Amcis Limited (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

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Successful FDA Inspection at Neuland, Switzerland

  • BUBENDORF, Switzerland (August 6, 2019) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today its Hunzenschwil (Neuland), Switzerland API manufacturing site has successfully completed a U.S. Food and Drug Administration (FDA) pre-approval inspection.

Successful FDA Inspection at Neuland, Switzerland

BUBENDORF, Switzerland (August 6, 2019) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today its Hunzenschwil (Neuland), Switzerland API manufacturing site has successfully completed a U.S. Food and Drug Administration (FDA) pre-approval inspection. 

The four-day, pre-approval inspection was undertaken by an FDA investigator from July 8-11, 2019. The inspection was concluded with no Form 483’s filed, thus confirming that no critical or major observation was raised during the inspection. The auditor will recommend the approval of API for which the audit was conducted. The final Establishment Inspection Report (EIR) is expected within the next six months.

“This latest pre-approval confirms the total commitment to quality and teamwork of each of our colleagues working across the entire company. Our team successfully completed the audit with the best possible result, thus ensuring our Client can progress towards bringing an important new treatment to patients,” said Mark Griffiths, Dishman Carbogen Amcis Group CEO. “I would like to congratulate everyone for the teamwork and the effort provided, and thank our clients for their continued trust in our Company.”

“This result is a continuation of a series of positive inspections across CARBOGEN AMCIS, reinforcing our successful history of regular FDA (11), Swissmedic (each Swiss site inspected every 2-3 years), Korean FDA (2) and ANSM (2) audits,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS.

“The successful audit is invaluable for our customers and the continued culture of quality for our business,” commented J.R. Vyas, Chairman of the Dishman Group. “Our priority is to put patients’ safety first and that is what drives us every day. All sites of the group are involved in the process of continuously improving our quality performance, and I encourage everyone to keep this commitment at the forefront of their daily activities.”

The Hunzenschwil facility is one of CARBOGEN AMCIS’ four sites to offer development and manufacturing facilities for highly potent compounds. It manufactures products according to cGMP standards and is routinely inspected by Swissmedic, the FDA and external customers. Located in the district of Lenzburg in the canton of Aargau 25 km west of Zurich, the manufacturing site was opened in 2000.

Site information at-a-glance:

  • Analytical services
  • API and intermediate stability studies
  • API process research and development
  • Small-scale commercial API supply
  • Crystallization laboratory
  • FDA, MFDS and Swissmedic inspected

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is a wholly owned subsidiary of Dishman Carbogen Amcis Limited., Ahmedabad, India


Dishman Carbogen Amcis Limited (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

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COVID-19

  • We at Dishman Carbogen Amcis group of companies are taking the risks associated with COVID-19 very seriously, and have already implemented a set of measures aimed at limiting any risk to our employees, customers and patients. We have already established a dedicated working team who monitor the COVID-19 outbreak and all processes have been analyzed with regards to risks. This allows us to have all our operations running smoothly and we currently do not have an impact on our operations.

COVID-19

  • English

    Dear Customers and Partners,

    We at Dishman Carbogen Amcis group of companies are taking the risks associated with COVID-19 very seriously, and have already implemented a set of measures aimed at limiting any risk to our employees, customers and patients. We have already established a dedicated working team who monitor the COVID-19 outbreak and all processes have been analyzed with regards to risks. This allows us to have all our operations running smoothly and we currently do not have an impact on our operations.

    We are facing a unique situation in several of the countries where we have facilities. National governments are implementing measures and issuing advice to both companies and the public that will affect our organization. Nevertheless, we want to assure you that, even under these circumstances, we will continue our operations during this period of uncertainty for as long as it remains safe for our employees and/or physically possible within National Government regulations.

    We continually assess the situation to ensure the continuity of our services to you.

    To this end, we review daily the situation and all projects. If the situation on a daily basis would have any consequences for our work on your behalf, be assured that we will inform you, in an individual and personalized manner to discuss individual projects and plans. Accordingly, there is no need to request any further update at this time, your project manager or commercial contact will get in touch with you if at all necessary. 

    Again, we are committed to doing everything possible to limit the impact this situation could have on your projects.

    A summary of the measures already implemented by our teams to protect our employees and partners is attached to this letter.

    I wish you and your families and colleagues all the very best, including good health, and sincerely hope that this situation will improve over the coming weeks and months. Our entire global team remains at your disposal for any questions you may have.

    Mark C Griffiths
    Global CEO
    Dishman Carbogen Amcis


    Actions already implemented:

    1. Placing employees’ health, customers’ protection and patient safety first
    • Our employees receive regular updates and clear guidelines, especially hygiene requirements.
    • We have already taken measures to protect our employees at all our different locations, including limitation of contact (e.g. handshakes and other forms of physical greetings, …), quarantine of people coming back from high-risk areas, and installing disinfectant dispensers at site entrances.
    • Sick employees are not permitted to come on site. They must also inform HR of the state of their health.
    • We are following all local authorities’ recommendations and instructions to fight against virus propagation at all our site.
    • In the case of external visitors or third party contractors, the host/internal contact person is responsible for clarifying (in advance) whether the people stayed in or were in contact with persons from crisis areas in the last 14 days. In the event of suspected cases, the visit will be postponed. This procedure is under evaluation on a weekly basis and can be adjusted if the situation requires it.
    • All customer visits have been cancelled
    1. A secure supply chain

    Now as the pandemic status has been declared by the WHO the situation is considered as a Force Majeure situation. We do every effort to keep our supply chain channels open. Our supply chain has been assessed and we do not see any short-term risk of product shortage, because a large part of it is integrated within our group of companies.

    1. Avoiding unnecessary risks
    • All our meetings are to be conducted over teleconferences to limit face-to-face assemblies (e.g., restriction of travel between sites excepted for emergencies.)
    • Business trips are not permitted
    • We are moving to home office work for employees who are able to do so in order to minimize direct close personal contact with colleagues. Any colleagues in contact with the crisis area or suspected of being infected are required to remain at home and self-isolate.

    As a general reminder, even under normal conditions outside of pandemic periods, all our workers operate according to standard manufacturing procedures and apply to quality standards/SOPs dedicated to hygiene, (Personnel Hygiene, Clothing Policy and Industrial Hygiene) that maintains a high standard level of protection for people and products.

  • French

    Chers clients et partenaires,

    Le groupe d’entreprises Dishman Carbogen Amcis prend très au sérieux la menace que représente le COVID-19 (Coronavirus) et a déjà mis en oeuvre un ensemble de mesures visant à limiter tout risque pour ses employés, ses clients et ses patients. Nous avons déjà constitué une équipe de travail spécialisée qui surveille l’épidémie de COVID-19 et tous les processus ont été analysés au regard des risques. Cela nous permet d’assurer le bon déroulement de toutes nos opérations et nous ne subissons actuellement aucun impact sur nos activités.

    Nous sommes confrontés à une situation unique dans plusieurs des pays où nous sommes implantés. Les gouvernements nationaux instaurent des mesures et émettent des conseils à l’intention des entreprises et du public qui auront une incidence sur notre organisation. Néanmoins, nous tenons à vous assurer que, même dans ces circonstances, nous maintiendrons nos activités pendant cette période d’incertitude aussi longtemps que cela restera sans danger pour nos employés et/ou physiquement possible dans le cadre des réglementations du gouvernement national.

    Nous évaluons continuellement la situation afin d’assurer la continuité de nos services envers vous.

    Pour ce faire, nous examinons quotidiennement la situation et tous les projets. S’il devait y avoir des conséquences au quotidien sur notre travail en votre nom, soyez assuré que nous vous en informerons, de manière individuelle et personnalisée, pour discuter des projets et des plans individuels. Par conséquent, il n’est pas nécessaire de demander d’autres mises à jour pour le moment, votre chef de projet ou interlocuteur commercial prendra contact avec vous si nécessaire.

    Une fois encore, nous nous engageons à faire tout notre possible pour limiter l’impact que cette situation pourrait avoir sur vos projets.

    Un récapitulatif des mesures déjà mises en oeuvre par nos équipes pour protéger nos employés et partenaires est joint à cette lettre.

    Je vous souhaite, ainsi qu’à vos familles et à vos collègues, le meilleur, notamment une bonne santé, et j’espère sincèrement que cette situation s’améliorera au cours des semaines et des mois à venir. L’ensemble de notre équipe se tient à votre disposition pour répondre à toutes les questions que vous pourriez avoir.

    Mark C Griffiths
    Global CEO
    Dishman Carbogen Amcis


    Mesures déjà mises en oeuvre :

    1. Priorité à la santé des employés, à la protection des clients et à la sécurité des patients

    • Nos employés reçoivent régulièrement des mises à jour et des directives claires, notamment concernant les exigences en matière d’hygiène.

    • Nous avons déjà pris des mesures pour protéger nos employés sur tous nos différents sites, notamment la limitation des contacts (par exemple, poignées de main et autres formes de salutations physiques, etc.), la mise en quarantaine des personnes revenant de zones à haut risque, et l’installation de distributeurs de désinfectant à l’entrée des sites.

    • Les employés malades ne sont pas autorisés à venir sur les sites. Ils doivent également informer les Ressources humaines de leur état de santé.

    • Nous nous conformons à toutes les recommandations et instructions des autorités locales pour lutter contre la propagation des virus sur l’ensemble de nos sites.

    • Concernant les visiteurs externes ou les tiers contractuels, l’interlocuteur hôte/interne est tenu de préciser (à l’avance) si les personnes ont séjourné ou ont été en contact avec des personnes provenant de zones de crise au cours des 14 derniers jours. En cas de suspicion, la visite sera reportée. Cette procédure fait l’objet d’une évaluation hebdomadaire et peut être adaptée si la situation l’exige.

    • Toutes les visites de clients ont été annulées.

    1. Une chaîne d’approvisionnement sûre

    Maintenant que le statut de pandémie a été déclaré par l’OMS, la situation est considérée comme un cas de force majeure. Nous faisons tout notre possible pour que nos canaux d’approvisionnement restent ouverts. Après évaluation de notre chaîne d’approvisionnement, nous n’anticipons aucun risque de pénurie de produits à court terme, car celle-ci est en grande partie intégrée à notre groupe d’entreprises.

    1. Prévention des risques inutiles

    • Toutes nos réunions doivent se dérouler par téléconférence afin de limiter les rassemblements en face à face (par exemple, restriction des déplacements entre les sites sauf en cas d’urgence).

    • Les voyages d’affaires ne sont pas autorisés.

    • Nous incitons fortement au télétravail pour les employés qui le peuvent, afin de réduire au minimum les contacts personnels rapprochés et directs avec les collègues. Tous les collègues en contact avec la zone de crise ou soupçonnés d’être infectés sont tenus de rester chez eux et de s’isoler.

    Pour rappel, même dans des conditions normales en dehors des périodes pandémiques, tous nos collaborateurs travaillent selon des procédures de fabrication standard et appliquent des normes de qualité/procédures opérationnelles normalisées dédiées à l’hygiène (hygiène du personnel, politique vestimentaire et hygiène industrielle) qui maintiennent un niveau de protection élevé pour les personnes et les produits.

  • German

    Sehr geehrte Kunden und Partner,

    Wir von der Unternehmensgruppe Dishman Carbogen Amcis nehmen die mit COVID-19 verbundenen Risiken sehr ernst und haben bereits eine Reihe von Massnahmen ergriffen, um das Risiko für unsere Mitarbeiter, Kunden und Patienten zu begrenzen. Wir haben bereits ein spezielles Arbeitsteam eingerichtet, das den COVID-19-Ausbruch überwacht, und alle Arbeitsprozesse wurden im Hinblick auf die bestehenden Risiken analysiert. Dies ermöglicht uns einen reibungslosen Ablauf all unserer Tätigkeiten, und bis zum jetzigen Zeitpunkt hat dies keine Auswirkungen auf unsere Arbeit.

    Wir stehen in mehreren Ländern, in denen wir Niederlassungen haben, vor einer außssergewöhnlichen Situation. Die nationalen Regierungen setzen Massnahmen um und geben Empfehlungen sowohl für Unternehmen als auch für die Öffentlichkeit, die sich auf unsere Organisation auswirken. Wir möchten Ihnen jedoch versichern, dass wir auch unter den gegebenen Umständen unsere Geschäftstätigkeit in dieser Zeit der Unsicherheit fortsetzen werden, solange dies für unsere Mitarbeiterinnen und Mitarbeiter sicher und/oder im Rahmen der Vorschriften der nationalen Regierungen physisch möglich bleibt.

    Wir bewerten die Situation kontinuierlich, um die Weiterführung unserer Dienstleistungen für Sie sicherzustellen.

    Zu diesem Zweck überprüfen wir täglich die Situation und alle Projekte. Wenn die tägliche Situation Konsequenzen auf unsere für Sie geleistete Arbeit haben sollte, können Sie sich darauf verlassen, dass wir Sie auf individuelle und persönliche Art und Weise darüber informieren werden, um einzelne Projekte und Pläne zu besprechen. Dementsprechend besteht zu diesem Zeitpunkt kein Anlass dazu, weitere Aktualisierungen anzufordern. Ihr Projektmanager oder geschäftlicher Kontaktpartner wird sich bei Bedarf mit Ihnen direkt in Verbindung setzen.

    Wir betonen, dass wir alle bestrebt sind, alles Erforderliche zu tun, um die Auswirkungen dieser Situation auf Ihre Projekte möglichst gering zu halten.

    Eine Zusammenfassung aller Maßnahmen, die unsere Teams bereits zum Schutz unserer Mitarbeiter und Partner ergriffen haben, ist diesem Schreiben beigefügt. 

    Ich wünsche Ihnen und Ihren Familien und Kollegen alles Gute sowie eine gute Gesundheit und hoffe aufrichtig, dass sich diese Situation in den kommenden Wochen und Monaten verbessern wird. Unser gesamtes globales Team steht Ihnen jederzeit für weitere Fragen zur Verfügung.

    Mark C Griffiths
    Global CEO
    Dishman Carbogen Amcis


    Bereits ergriffene Massnahmen:

    1. Die Gesundheit unserer Mitarbeitenden, der Schutz unserer Kunden und die Sicherheit der Patienten stehen an erster Stelle
    • Unsere Mitarbeiter erhalten regelmässige Aktualisierungen und klare Richtlinien, insbesondere in Bezug auf Hygieneanforderungen.
    • Wir haben bereits Massnahmen ergriffen, um unsere Mitarbeitende an all unseren verschiedenen Standorten zu schützen, einschliesslich Kontaktbeschränkungen (z.B. Händeschütteln und andere mit Körperkontakt verbundene Formen der Begrüssung usw.), Quarantäne von Personen, die aus Risikogebieten zurückkehren sowie die Installation von Desinfektionsmittelspendern an den Eingängen der Standorte.
    • Erkrankte Mitarbeitende dürfen den Standort nicht betreten. Darüber hinaus müssen Sie die Personalabteilung über ihren Gesundheitszustand informieren.
    • Wir befolgen die Empfehlungen und Anweisungen der lokalen Behörden zur Eindämmung der Virusausbreitung an allen Standorten.
    • Bei externen Besuchern oder Fremdfirmen ist der Gastgeber/interne Ansprechpartner dafür verantwortlich, (im Voraus) zu klären, ob sich die betreffenden Personen selbst in den letzten 14 Tagen in Risikogebieten aufgehalten haben oder mit entsprechenden Personen in Kontakt standen. Bei Verdachtsfällen wird der Besuch verschoben. Dieses Verfahren wird wöchentlich bewertet und kann bei Bedarf angepasst werden.
    • Alle Kundenbesuche wurden abgesagt. 
    1. Eine sichere Lieferkette 

    Nachdem die WHO den Pandemiestatus erklärt hat, gilt die bestehende Situation als höhere Gewalt. Wir bemühen uns, unsere Lieferkettenkanäle so weit wie möglich offen zu halten. Unsere Lieferkette wurde evaluiert und wir sehen derzeit kein kurzfristiges Risiko für Produktausfälle, da ein grosser Teil davon in unsere Unternehmensgruppe integriert ist.

    1. Unnötige Risiken vermeiden
    • All unsere Treffen sollen nun über Telefonkonferenzen durchgeführt werden, um persönliche Versammlungen einzuschränken (z.B. Reisebeschränkung zwischen Standorten, mit Ausnahme von Notfällen).
    • Geschäftsreisen sind nicht gestattet.
    • Alle Mitarbeiter, die dazu in der Lage sind, sollen nun im Home Office arbeiten, um den direkten engen persönlichen Kontakt mit Kollegen zu minimieren. Alle Kollegen, die mit Risikogebieten in Kontakt standen oder bei denen der Verdacht einer Infektion besteht, müssen zu Hause bleiben und sich selbst isolieren.

    Zur allgemeinen Erinnerung: All unsere Mitarbeiter arbeiten auch unter normalen Bedingungen und unabhängig von der Pandemie nach Standardfertigungsverfahren und Qualitätsstandards/SOPs zur Hygiene (Personalhygiene, Bekleidungsvorschriften und Arbeitshygiene), die ein hohes Standardniveau zum Schutz von Menschen und Produkten aufrechterhalten

  • Dutch

    Beste klanten en partners,

    Bij de Dishman Carbogen Amcis-bedrijvengroep nemen we de risico's die aan COVID-19 zijn verbonden zeer serieus en hebben we al een reeks maatregelen geïmplementeerd, die zijn bedoeld om het risico voor onze werknemers, klanten en patiënten te beperken. We hebben al een toegewijd team opgericht die de ontwikkelingen rondom de de COVID-19 uitbraak volgt en zijn alle werkprocessen geanalyseerd met betrekking tot de risico's. Dit laat ons toe om al onze activiteiten soepel te laten verlopen en we ondervinden momenteel nog geen impact op onze activiteiten.

    We worden geconfronteerd met een unieke situatie in verschillende landen waar we activiteiten hebben. Nationale overheden implementeren maatregelen en geven advies aan zowel bedrijven als het publiek die van invloed zal zijn op onze organisatie. Desalniettemin willen we u verzekeren dat we, zelfs onder deze omstandigheden, onze activiteiten zullen voortzetten gedurende deze periode van onzekerheid, zolang de veiligheid van onze werknemers is geborgd en conform de richtlijnen van de nationale overheidsvoorschriften.

    We beoordelen de situatie voortdurend om de continuïteit van onze producten aan u te garanderen.

    Om dit te bereiken, evalueren we dagelijks de situatie. Als de dagelijkse situatie gevolgen heeft voor ons werk en indirect gevolgen heeft voor onze verplichtingen aan u, kunt u er zeker van zijn dat we u op een individuele en persoonlijke manier zullen informeren over actuele- en toekomstige leveringen.

    Nogmaals, we doen er alles aan om de impact, die deze situatie zou kunnen hebben, op uw leveringen te beperken.

    Een samenvatting van de maatregelen die onze teams reeds hebben genomen om onze werknemers en partners te beschermen, is aan deze brief toegevoegd.

    Ik wens u en uw families en collega's het allerbeste toe, inclusief een goede gezondheid, en hoop van harte dat deze situatie de komende weken en maanden zal verbeteren. Ons hele wereldwijde team blijft tot uw beschikking voor alle vragen die u misschien zal hebben.

    Mark C Griffiths
    Global CEO
    Dishman Carbogen Amcis


    Reeds geïmplementeerde acties:

    1. De gezondheid van werknemers, de bescherming van klanten en patiëntveiligheid staan voorop
    • Onze werknemers ontvangen regelmatige updates en duidelijke richtlijnen, vooral hygiëne-eisen.
    • We hebben al maatregelen genomen om onze werknemers op al onze verschillende locaties te beschermen, waaronder beperking van contact (bijv. handdrukken en andere vormen van fysieke begroetingen, ...), quarantaine van mensen die terugkomen uit risicovolle gebieden en het installeren van desinfecterende dispensers bij de ingangen van de site.
    • Voor zieke werknemers is het verboden om op de site te komen. Ze moeten HR ook informeren over de toestand van hun gezondheid.
    • We volgen alle aanbevelingen en instructies van de lokale autoriteiten om de verspreiding van het virus op al onze sites te voorkomen.
    • In het geval van externe bezoekers of externe contractanten, is de gastheer/ interne contactpersoon verantwoordelijk voor het (voorafgaand) verduidelijken of de mensen de afgelopen 14 dagen hebben verbleven in of contact hebben gehad met personen uit de crisisgebieden. In het geval van vermodelijke gevallen zal het bezoek worden uitgesteld. Deze procedure wordt wekelijks geëvalueerd en kan worden aangepast indien de situatie dit vereist.
    • Alle klantenbezoeken zijn geännuleerd.
    1. Een veilige toeleveringsketen

    Nu de status van de pandemie door de WHO is vastgesteld, wordt de situatie beschouwd als een situatie van overmacht. We doen er alles aan om onze kanalen van de toeleveringsketen open te houden. Onze toeleveringsketen is beoordeeld en we zien geen kortetermijnrisico op productietekort, omdat een groot deel daarvan geïntegreerd is binnen onze bedrijvengroep.

    1. Vermijd onnodige risico's
    • Al onze vergaderingen moeten worden gehouden via teleconferenties om persoonlijke vergaderingen te beperken (bijv. beperking van reizen tussen sites behalve voor noodsituaties.)
    • Zakenreizen zijn niet toegestaan
    • We gaan over naar kantoorwerk van thuis voor werknemers die in staat zijn om dit te doen om direct persoonlijk contact met collega's te minimaliseren. Alle collega's die in contact komen met het crisisgebied of vermoedelijk zijn besmet, moeten thuis blijven en zichzelf isoleren.

    Ook onder normale omstandigheden buiten de pandemieperioden, werken al onze werknemers volgens standaard fabricageprocedures en voldoen ze aan kwaliteitsnormen/SOP’s. Hierin zijn de maatregelen ten aanzien van de hygiëne, (persoonlijke hygiëne, kledingbeleid en industriële hygiëne) vastgelegd en die een hoog standaard niveau van bescherming borgen voor mensen en producten.

  • Chinese

    尊敬的客户及合作伙伴:

    Dishman Carbogen Amcis 集团公司正在积极地处理与 COVID-19  有关的风险,且已采取一系列措施最小化员工、客户和患者所面临的任何风险。我们已成立专门的工作小组来监控 COVID-19 的传播,并已对所有流程进行风险分析。此举可确保我们的所有项目得以顺利进行,而且我们的运营目前未受任何影响。

    我们拥有生产基地的不同国家所面临的状况也不尽相同。各国政府正在采取措施并向企业和公众发出建议,这将对我们的构造运营造成一定的影响。尽管如此,但我们依然努力,在确保我们的员工安全且各国政府规定允许的范围内,我们也将在这个充满不确定性的时间段内继续我们的业务。

    我们会持续评估形势的发展,以确保继续为您提供服务。

    为此,我们会每天审查疫情状况和所有项目。如果当日的疫情状况会对我们为您的项目开展的任何工作产生任何影响,请放心,我们会以不同的方式通知您,并针对相关项目和计划进行讨论。如有必要,与您联系的项目经理或者商务部联系人将与您取得联系。

    再次说明,我们承诺采取一切可行的措施来限制此次疫情可能会对您的项目产生的影响。

    我们的团队已采取的、致力于保护员工和合作伙伴的措施摘要随附于本函件。

    我在此祝愿您和您的家人、同事一切安好,健康平安,并真诚地希望这种状况在未来几周和几个月内会有所改善。我们的全球团队随时准备为您的疑问作出解答。

    Mark C Griffiths
    Global CEO
    Dishman Carbogen Amcis
    全球 CEO


    已实施的措施:

    1.将员工的健康、客户的防护和病人的安全放在第一位

    • 我们会定期向员工传达最新的消息及明确的指导方针,尤其是卫生要求。
    • 我们已在所有工作场所采取措施保护我们的员工,包括接触限制(例如,握手及其他形式身体接触问候等等)、对从高危地区返回的人员进行隔离、及在办公厂址入口安装消毒剂分发器。
    • 生病的员工禁止来公司办公。其也必须向该国的人力资源部通报其健康状况。
    • 我们正在遵循所有地方当局的建议和指示,在所有工作场所抗击病毒的传播。
    • 如果外部人员或第三方承包商来访,负责人/内部联络人负责(提前)明确该等人士在过去 14 天内是否去过高危地区或与来自高危地区的人士有接触。如果出现疑似病例,拜访将会被推迟。我们每周会对这一程序进行评估,如果状况需要,则会进行调整。
    • 所有客户拜访均已取消

    2.安全的供应链 

    世界卫生组织现已宣布疫情处于大流行状态,而这种情况被认为是不可抗力。我们竭尽全力保持我们的供应链渠道开放。我们已对供应链进行评估,而且我们目前未看到任何产品短缺的短期风险,因为大部分都整合在我们的集团公司内部。

    3.避免不必要的风险。

    • 我们所有的会议都将通过电话会议进行,以限制面对面集会(例如,限制不同办公厂址之间的差旅,紧急情况除外)。
    • 禁止出差
    • 为了尽量减少同事间直接的个人接触,我们已经安排可在家办公的同事于家中办公。与高危地区有接触的或疑似被感染的同事必须在家自我隔离。

    再提醒一下,即使在没有发生疫情的正常情况下,我们所有的员工都遵照标准的制造流程操作,并严格遵照卫生方面的质量标准和SOP(个人卫生、着装政策和劳动卫生),为我们的员工和产品提供高标准的保护。

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CARBOGEN AMCIS announces major investments of more than CHF 100 million in Switzerland and France

  • We at Dishman Carbogen Amcis group of companies are taking the risks associated with COVID-19 very seriously, and have already implemented a set of measures aimed at limiting any risk to our employees, customers and patients. We have already established a dedicated working team who monitor the COVID-19 outbreak and all processes have been analyzed with regards to risks. This allows us to have all our operations running smoothly and we currently do not have an impact on our operations.

CARBOGEN AMCIS announces major investments of more than CHF 100 million in Switzerland and France

  • English

    BUBENDORF, Switzerland (August 17, 2020) — Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and drug products manufacturing company, announced today new expansion plans in Switzerland and France. 

    CARBOGEN AMCIS announces two major expansion projects that will increase manufacturing capacity to better meet the demands of the current market and its customers. The new facilities, located in Switzerland and France, will be phased in over the next four years, totaling investments in excess of CHF 100m (over €90 million). This follows six years of constant growth for the company.

    In Switzerland, the project will be initiated in 2021 with construction of a new API manufacturing facility at its Hunzenschwil site. This project will progress in several phases. It is planned for this new unit to be operational by summer 2024.

    “The facility is designed to provide space for CARBOGEN AMCIS to grow over the next 10 years with the initial phase comprising of 12 new vessels (from 630 liters to 4000 liters) and associated filtration and drying capabilities,” said Stephan Fritschi, vice president of operations. “We have an impressive pipeline, and now our customers can benefit from more diverse offerings.”

    In addition to the new Swiss API manufacturing facility, additional investments are planned with a dedicated budget to improve some of the existing technologies and to increase the capacity of the current Swiss sites, such as adding chromatography equipment, new reactors in production and new laboratories.

    In France, on newly acquired land located 7 km from an existing site in Riom, construction will begin in January 2021 with a new, state-of-the-art facility dedicated to custom development and manufacturing of parenteral drug products. This facility will allow handling complex formulations, including a large range of different types of APIs from biologics to any kind of highly potent compounds.

    “After years of growth, it’s exciting to have reached our current production limits and to be able to expand our facilities and grow our capacity, which will match the future market demand,” said Pascal Villemagne, vice president of sales and marketing. “Our new facility in Riom will not only enable us to support more customers, but will also give them access to innovative fill and finish technologies.”

    The new French site will be able to supply both clinical batches up to phase III and small-scale for commercial. There will be two automated lines: the first one for both liquid filling plus lyophilization and the second one dedicated to liquid forms. In addition, state-of-the-art development and analytical laboratories will be incorporated to support customer projects. Operations will commence during Q1 of 2023.

    “Our objective is ambitious, nevertheless, we are taking a responsible approach to our growth in order to give the company and our employees a sustainable future. As an established leader in the pharmaceutical outsourcing industry for the past 40 years and with strong relationships with our customers, our company is ready to take this next step in capability and capacity. We are embarking on the expansions in order to secure CARBOGEN AMCIS’s position,” said Mark Griffiths, CARBOGEN AMCIS CEO.

    Photo caption: The new facility in Riom, France will allow CARBOGEN AMCIS to support more customers and enables access to innovative fill and finish technologies.

    ****

    CARBOGEN AMCIS (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS is owned by Dishman Carbogen Amcis Limited, Ahmedabad, India. 

    Dishman Carbogen Amcis Limited (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in India. 

     

  • French

    CARBOGEN AMCIS annonce d’importants investissements de plus de 100 millions de francs suisses (plus de 90 millions d’euros) en Suisse et en France

    BUBENDORF, Suisse (le 17. août 2020) - La société suisse CARBOGEN AMCIS, qui développe des procédés pharmaceutiques et fabrique des principes actifs (API) et des médicaments, a annoncé aujourd’hui de nouveaux plans d’expansion en Suisse et en France.

    CARBOGEN AMCIS annonce deux grands projets d’expansion visant à augmenter sa capacité de production pour mieux répondre aux exigences du marché et de ses clients. Ces nouvelles installations, situées en Suisse et en France, seront déployées progressivement au cours des quatre prochaines années. L’investissement total s’élève à plus de 100 millions de francs suisses (plus de 90 millions d’euros). Cette évolution s’inscrit dans le prolongement de six années de croissance constante de l’entreprise.

    Le projet sera lancé pour la Suisse en 2021 avec la construction d’une nouvelle unité de production de principes actifs sur le site de Hunzenschwil. Il se déroulera en plusieurs phases. La nouvelle unité devrait être opérationnelle d’ici l’été 2024.

    « L’installation est conçue pour permettre l’expansion de CARBOGEN AMCIS au cours des dix prochaines années. La phase initiale comprendra 12 nouveaux réacteurs (de 630 litres à 4 000 litres) avec les capacités de filtration et de séchage associées », explique Stephan Fritschi, vice-président opérations. « Notre portefeuille est impressionnant, et nos clients vont désormais bénéficier d’offres plus diversifiées. »

    Outre la nouvelle usine suisse de fabrication de principes actifs, des investissements supplémentaires sont prévus, avec un budget dédié qui permettra d’améliorer certaines technologies existantes et d’augmenter la capacité des sites suisses actuels, comme l’ajout d’équipements de chromatographie, de nouveaux réacteurs en production et de nouveaux laboratoires.

    En France, la construction commencera en janvier 2021 sur un terrain nouvellement acquis situé à 7 km du site actuel de Riom. Il accueillera un nouveau bâtiment ultramoderne dédié au développement et à la fabrication de médicaments à usage parentéral. Celui-ci permettra de traiter des formulations complexes, notamment une large gamme de différents types de principes actifs, allant des produits biologiques à tout type de composés hautement actifs.

    « Après des années de croissance, il est stimulant d’avoir atteint nos limites de production actuelles, de pouvoir nous agrandir et augmenter notre capacité afin de répondre aux demandes futures du marché », commente Pascal Villemagne, vice-président ventes et marketing. « Notre établissement de Riom nous permettra non seulement de soutenir plus de clients, mais il leur donnera aussi accès à des technologies de remplissage et de finition (Fill and Finish) innovantes. » 

    Le nouveau site français sera en mesure de fournir à la fois des lots cliniques jusqu’à la phase III et des lots commerciaux à petite échelle. Deux lignes automatisées y seront déployées : la première pour le remplissage de liquides plus la lyophilisation et la seconde dédiée aux formes liquides. En outre, des laboratoires de recherche et de développement de pointe seront intégrés pour soutenir les projets des clients. Les opérations commenceront au cours du premier trimestre 2023.

    « Notre objectif est certes ambitieux, mais nous adoptons une approche responsable de notre croissance afin de donner à l’entreprise et à nos collaborateurs un avenir durable. En tant que leader établi depuis 40 ans dans le secteur de la sous-traitance pharmaceutique et grâce aux relations solides que nous entretenons avec nos clients, notre entreprise est prête à franchir ce nouveau cap en termes de capacité et de compétences. Nous nous lançons dans ces projets d’expansion afin de sécuriser la position de CARBOGEN AMCIS », souligne Mark Griffiths, PDG de CARBOGEN AMCIS.

    ****

    CARBOGEN AMCIS (www.carbogen-amcis.com) est un prestataire de services de premier plan qui propose un portefeuille de services de développement et de commercialisation de médicaments aux industries pharmaceutique et biopharmaceutique à chaque étape du développement clinique et du cycle de vie des produits. Nos services intégrés et nos solutions chimiques innovantes favorisent un développement rapide et sûr des médicaments, ce qui permet à nos clients de mieux optimiser les ressources disponibles. CARBOGEN AMCIS est une filiale à part entière de Dishman Carbogen Amcis Limited, Ahmedabad, Inde.

    Dishman Carbogen Amcis Limited (www.dishmangroup.com) est un partenaire de sous-traitance mondial pour l’industrie pharmaceutique, offrant un portefeuille de services de développement, d’échelle et de fabrication. Le groupe Dishman Carbogen Amcis améliore les activités de ses clients en fournissant une gamme de solutions de développement et de fabrication sur des sites en Inde. 

     

  • German

    CARBOGEN AMCIS kündigt Investitionen von mehr als 100 Millionen Schweizer Franken (90 Millionen Euro) in der Schweiz und Frankreich an

    BUBENDORF, Schweiz (17. August 2020) – das Schweizer Unternehmen CARBOGEN AMCIS, das pharmazeutische Verfahren entwickelt und aktive pharmazeutische Wirkstoffe (API) und Arzneimittel herstellt, hat heute neue Expansionspläne in der Schweiz und in Frankreich bekanntgegeben.

    CARBOGEN AMCIS kündigt zwei grosse Expansionsvorhaben zur Erhöhung der Produktionskapazitäten an, um den aktuellen Kunden- und Marktanforderungen besser gerecht zu werden. Anknüpfend an das kontinuierliche Unternehmenswachstum der letzten sechs Jahre werden die neuen Anlagen in der Schweiz und in Frankreich in den nächsten vier Jahren schrittweise in die Infrastruktur integriert und umfassen ein Gesamtinvestitionsvolumen von mehr als 100 Millionen Schweizer Franken (über 90 Millionen Euro).

    In der Schweiz wird das Projekt 2021 mit dem Bau einer neuen API-Produktionsanlage am Standort Hunzenschwil in Angriff genommen. Das Projekt umfasst mehrere Phasen. Die neue Niederlassung soll bis Sommer 2024 in Betrieb genommen werden.

    „Das Werk soll CARBOGEN AMCIS in den nächsten 10 Jahren anfänglich mit 12 neuen Reaktoren (von 630 bis 4000 Liter) und den damit verbundenen Filtrations- und Trocknungskapazitäten in seinem Wachstum unterstützen“, so Stephan Fritschi, Vizepräsident Operations. „Wir haben bereits eine beeindruckende Pipeline und können nun unseren Kunden ein noch vielfältigeres Angebot bieten.“

    Zusätzlich zu der neuen Schweizer API-Produktionsanlage sind weitere Investitionen mit einem zweckgebundenen Budget geplant, um einige der bestehenden Technologien zu verbessern und die Kapazität der aktuellen Schweizer Standorte zu steigern. Dazu gehören beispielsweise zusätzliche Chromatographie-Anlagen, neue Reaktoren in der Produktion und Laborausbauten.

    In Frankreich beginnt im Januar 2021 auf einem neu erworbenen Gelände nur 7 km von dem bisherigen Standort in Riom entfernt der Bau einer neuen, hochmodernen Anlage für die kundenspezifische Entwicklung und Herstellung parenteraler Arzneimittel. Dieses Werk ermöglicht die Handhabung komplexer Formulierungen, einschliesslich einer grossen Auswahl an verschiedenen Arten von APIs, von Biologika bis hin zu hochwirksamen Verbindungen jeglicher Art.

    „Nach Jahren des Wachstums ist es aufregend, unsere derzeitigen Produktionsgrenzen erreicht zu haben und nun unsere Anlagen und Kapazitäten erweitern zu können, um der zukünftigen Marktnachfrage zu entsprechen“, sagt Pascal Villemagne, Vizepräsident Vertrieb und Marketing „Mit unserem neuen Werk in Riom können wir nicht nur mehr Kunden erreichen, sondern ihnen auch Zugang zu innovativen Fill-&-Finish-Technologien eröffnen.“

    Der neue französische Standort wird sowohl klinische Chargen bis zur Phase III als auch kleine Chargen für den kommerziellen Einsatz liefern können. Er wird zwei automatisierte Produktionslinien umfassen: die erste für die Abfüllung flüssiger Formen sowie Lyophilisierung und die zweite ausschliesslich für flüssige Formen. Darüber hinaus werden hochmoderne Entwicklungs- und Analyselabore zur Unterstützung von Kundenprojekten eingerichtet. Der Betrieb soll im ersten Quartal 2023 aufgenommen werden.

    „Unser Ziel ist ehrgeizig. Dennoch gehen wir verantwortungsvoll mit unserem Wachstum um, um dem Unternehmen und unseren Mitarbeitenden eine nachhaltige Zukunft zu bieten. Als in der pharmazeutischen Outsourcing-Industrie seit 40 Jahren etablierter Marktführer mit starken Beziehungen zu unseren Kunden ist unser Unternehmen bereit, diesen nächsten Schritt in Bezug auf unser Leistungsportfolio zu gehen. Wir nehmen die Expansion in Angriff, um die Marktposition von CARBOGEN AMCIS zu sichern“, meint Mark Griffiths, CEO von CARBOGEN AMCIS.

    ****

    CARBOGEN AMCIS (www.carbogen-amcis.com) ist ein führender Dienstleister für die pharmazeutische und biopharmazeutische Industrie, der mit einem Dienstleistungsportfolio zur Arzneimittelentwicklung und -vermarktung in allen Phasen der klinischen Entwicklung und des Produktlebenszyklus aufwarten kann. Die umfassenden Dienste bieten innovative chemische Lösungen für eine schnelle und sichere Arzneimittelentwicklung und ermöglichen Kunden eine bestmögliche Nutzung ihrer verfügbaren Ressourcen. CARBOGEN AMCIS gehört zu Dishman Carbogen Amcis Limited in Ahmedabad, Indien. 

    Dishman Carbogen Amcis Limited (www.dishmangroup.com) ist ein globaler Outsourcing-Partner für die Pharmaindustrie und bietet ein breites Portfolio an Entwicklungs-, Ausbau- und Fertigungsdienstleistungen. Die Dishman Carbogen Amcis Group unterstützt das Geschäft ihrer Kunden durch die Bereitstellung einer Reihe von Entwicklungs- und Fertigungslösungen an Standorten in Indien. 

     

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CARBOGEN AMCIS announces a co-investment agreement of more than CHF 15 million with a key client to expand Swiss site

  • BUBENDORF, Switzerland (April 29th, 2021) — Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and drug products manufacturing company, announced today a joint funding agreement with a long standing Japan based customer to build a site extension at the Bubendorf site in Switzerland.

CARBOGEN AMCIS announces a co-investment agreement of more than CHF 15 million with a key client to expand Swiss site

BUBENDORF, Switzerland (April 29th, 2021) — Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and drug products manufacturing company, announced today a joint funding agreement with a long standing Japan based customer to build  a site extension at the Bubendorf site in Switzerland.  

The expansion will be created adjacent to an existing manufacturing facility on the Bubendorf Switzerland Site. This important expansion will incorporate a new production line comprising of two 850 L reactors and one agitated filter drier. The facility is designed for highly potent manufacturing up to category 4 (OEL of 1 µg/m³ and lower).

“We are grateful for the trust our customer has placed in us by deciding to support the Bubendorf site extension. Their investment will enable the creation of a state-of-the art facility that will benefit them directly,” said Pascal Villemagne, VP sales and Marketing, CARBOGEN AMCIS. “This joint investment cements our working relationship over the long term and lays the foundation for a promising future.”

CARBOGEN AMCIS will produce exclusively for the signatory customer a complex highly potent drug component for a commercial antibody-drug-conjugate API. 

“The production of this intermediate involves five CARBOGEN AMCIS facilities around the world: three sites in Switzerland (Bubendof, Hunzenschwil and Aarau), one in the UK (Manchester) and one in China (Shanghai).The highly potent production element will take place in Bubendorf, in the new building extension.” Commented Mark Griffiths, CARBOGEN AMCIS CEO. “We are thrilled and honoured to collaborate with our customer on this project to treat patients of need and also proud to demonstrate our ability to integrate our global supply chain network.”

Currently, the planning phase for the building extension is underway and the Company expects to commence operations in autumn 2022.

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.

Dishman Carbogen Amcis Limited (imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 
 

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Dishman Carbogen Amcis Ltd announces successful results from the partnership with Boston University School of Medicine on study that uncovers treatment for vitamin D deficiency (2)

  • Ahmedabad, India (May 21th, 2021) — India-based Dishman Carbogen Amcis Limited, a global outsourcing partner for the pharmaceutical industry, welcomes the results of a new study that provides critical insights into the treatment of vitamin D deficiency in obesity and in fat malabsorption syndromes. The research was conducted by Boston University School of Medicine and supported in part by a grant from Dishman Carbogen Amcis Ltd’s wholly owned subsidiary CARBOGEN AMCIS B.V.

Dishman Carbogen Amcis Ltd announces successful results from the partnership with Boston University School of Medicine on study that uncovers treatment for vitamin D deficiency

Ahmedabad, India (May 21th, 2021) — India-based Dishman Carbogen Amcis Limited, a global outsourcing partner for the pharmaceutical industry, welcomes the results of a new study that provides critical insights into the treatment of vitamin D deficiency in obesity and in fat malabsorption syndromes. The research was conducted by Boston University School of Medicine and supported in part by a grant from Dishman Carbogen Amcis Ltd’s wholly owned subsidiary CARBOGEN AMCIS B.V.

Dishman Carbogen Amcis Ltd (DCAL) is a leading global manufacturer of vitamin D analogs and related APIs. DCAL partnered with Dr. Michael Holick, MD, PhD, professor of medicine, physiology and biophysics and molecular medicine at Boston University School of Medicine, to determine whether alternative vitamin D-type substances provide significant health benefits in people suffering with impaired distribution and metabolism of vitamin D.

“We believe that partnerships with academic institutions help uncover important insights and make great discoveries that benefit the pharmaceutical industry and, most importantly, the patients directly”, said Arpit Vyas, Global Managing Director of Dishman Carbogen Amcis Limited.

The study results will benefit obese people and, e.g., patients who have undergone gastric bypass surgery, which quite generally results in vitamin D malabsorption. Thus, those patients run an elevated risk of bone diseases like osteoporosis and osteomalacia due to softening of the bones. 

Researchers observed that a form of vitamin D, known as 25-hydroxyvitamin D3 (Calcifediol), was absorbed faster and better than the same dose of vitamin D. “This vitamin D metabolite is better absorbed in patients with fat malabsorption syndromes and since it is not as fat soluble, it does not get diluted in the body fat and is effective in raising and maintaining blood levels,” said Dr. Michael Holick. “Therefore, using 25-hydroxyvitamin D3 could be a novel approach for treating vitamin D deficiency in patients with fat malabsorption syndromes.”
CARBOGEN AMCIS B.V. provided the 25-hydroxyvitamin D3 capsules, which were produced at its parent company Dishman Carbogen Amcis Limited’s Bavla facility in Ahmedabad, specifically for this study, thus becoming yet another global project for DCAL. 

With over 70 years of vitamin D experience DCAL is one of the leading innovators, developer and manufacturers of vitamin D and its analogues. DCAL is engaged in these activities both at the DCAL location in Ahmedabad, India and at its CARBOGEN AMCIS B.V. location in the Netherlands which is also active in the production and sales of vitamin D analogs (e.g., Alfacalcidol, Calcifediol, and Calcitriol), Ergocalciferol, and Cholesterol and lanolin related products for key markets as pharmaceutical, cosmetic, food, feed as well as industry applications. DCAL manufactures raw material for vitamin D ingredients and develops a range of vitamin D analogs and metabolites which are used as APIs in pharmaceutical products across the world.
“Our Vitamin D activities are a source of particular pride. Since 2007 when the Netherlands facility was acquired by DCAL we have continually invested to ensure that we remain at the forefront of innovation. Our industry partners rely on the quality of the APIs we deliver. Through this collaboration with Boston University School of Medicine, we sought to advance our industry’s understanding of the full potential of vitamin D supplements for patients with various needs,” said  Rob Eijkman, site director CARBOGEN AMCIS B.V., Netherlands.  


“The collaboration with Boston University and Dr Holick has been an exercise in complete focus upon patients of need and efficient solutions to meet that need,” commented Dr Peter Müller, senior scientific advisor for DCAL. “Dishman Carbogen Amcis Limited has worked closely with Boston University School of Medicine on investigating the roles that vitamin D substances play in humans. In addition to the results of the study addressed here, the partnership has resulted in a mutually beneficial exchange of scientific views, including participation by Dr. Holick in scientific forums at DCAL.” 
For more information about the Boston University study supported by Dishman Carbogen Amcis Limited: https://academic.oup.com/ajcn/advance-article-abstract/doi/10.1093/ajcn/nqab123/6277980?redirectedFrom=fulltext 
 

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CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited., Ahmedabad, India.

Dishman Carbogen Amcis Limited (imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India. 
 

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