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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

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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

Ahmedabad, India (May 21th, 2021) — India-based Dishman Carbogen Amcis Ltd, 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, Ph.D., 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 from 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 Ltd.

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 Ltd’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, developers, and manufacturers of vitamin D and its analogs. 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 industrial 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 Ltd 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 Ltd: https://academic.oup.com/ajcn/advance-article-abstract/doi/10.1093/ajcn/nqab123/6277980?redirectedFrom=fulltext

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Dishman Carbogen Amcis Ltd (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.

CARBOGEN AMCIS AG (www.carbogenamcis.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 Ltd, Ahmedabad, India.

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

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

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 Ltd, Ahmedabad, India.  Dishman Carbogen Amcis Ltd (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. 

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ISO22716 Cosmetics GMP standard accreditation

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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. 

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 Ltd, Ahmedabad, India.        Dishman Carbogen Amcis Ltd 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 Statement on COVID-19

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Dishman Carbogen Amcis Ltd Statement on COVID-19

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 do everything possible to limit an 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 Ltd


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
2. 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.
 
3. 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.

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Dishman Carbogen Amcis Ltd. Announces a Successful FDA Inspection of its Site in Bavla, India

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Dishman Carbogen Amcis Ltd. Announces a Successful FDA Inspection of its Site in Bavla, India

Ahmedabad, India (November 5th, 2018) — India-based Dishman Carbogen Amcis Ltd, a global outsourcing partner for the pharmaceutical industry, announced today that its manufacturing and development facility in Bavla has successfully completed an inspection by the U.S. Food and Drug Administration (FDA).

The FDA’s Current Good Manufacturing Practices (CGMP) audit, which is performed to ensure proper design, monitoring and control of manufacturing processes and facilities, was held from October 22-26. The five-day inspection focused on the Active Pharmaceutical Ingredient (API) units and ancillary areas of the Bavla site, specifically the quality system, production and packaging operations. The inspection also included examinations of the warehouses and quality control areas. No critical observations were reported and the final Establishment Inspection Report (EIR) is expected within the next six months.

“I am extremely pleased with the positive outcome of this FDA inspection. It is the result of our ongoing dedication to maintaining high quality standards and continuously meeting our customers’ expectations,” said Mr. J. R. Vyas, Chairman and Founder of the Dishman Carbogen Amcis Ltd Group.

“It was especially rewarding for us to hear that the auditor appreciated our Team’s’ open communication and transparent way of working. I am very proud of our staff. Their commitment to excellence every day is the key to our performance and our long track record of successful audits,” said Dr Himani Dhotre, CEO of the DCAL Bavla Site.

The Bavla facility manufactures products according to CGMP standards and is routinely inspected by legal authorities and external customers. The facility underwent successful FDA inspections in 2006, 2012, 2015 and 2016.

In operation since 1996, the Bavla facility is Dishman Carbogen Amcis Ltd’ main site and employs more than 900 people. The site also features:

  • Large CMO and CRO capacity (300,000 m2) - 750 qm reactor capacity
  • Kg to multi tonne per annum batch scale
  • Commercial Highly Potent Category 4 API manufacturing
  • FDA approved, Kosher, EDQM, TGA and DCGI/WHO approved
  • Featuring special technologies: Ozonolysis, Irradiation, Spray Drying, Hydrogenation, Chromatography, Peptide Synthesis, Enzyme Technology
  • 13 manufacturing units on site
  • Fully facilitated ADL and R&D labs for development
  • ISO 9001, ISO 13485, ISO 14001 and OHSAS 18001 certification

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

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