News

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


5 November 2018

Ahmedabad, India (November 5th, 2018) — India-based Dishman Carbogen Amcis Limited, 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 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’ 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

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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 India.

Dishman Carbogen Amcis Opens Office in Kyoto, Japan


1 August 2018

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

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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 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

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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。

Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS


11 August 2016

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.

 

 

News

5 November 2018
Dishman Carbogen Amcis Ltd. Announces a Successful FDA Inspection of its Site in Bavla, India

1 August 2018
Dishman Carbogen Amcis Opens Office in Kyoto, Japan

11 August 2016
Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS

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