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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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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. 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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DISHMAN CARBOGEN AMCIS OPENS OFFICE IN KYOTO, JAPAN

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Dishman Carbogen Amcis Ltd 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 Ltd, 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 Ltd 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 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 Europe and in India.



ディシュマン・カーボゲン・アムシスが京都オフィスを開設

ブーベンドルフ、スイス(2018年8月1日) — スイスに本社を置くカーボゲン・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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