BUBENDORF, Switzerland (27 October 2021) — Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the completion of a U.S. Food and Drug Administration (FDA) inspection at the site in Aarau, Switzerland.
The pre-approval FDA paper inspection for an intermediate product from a customer was conducted from 17 August - 15 September 2021. By receiving the result in October 2021 the inspection was concluded successfully with no findings, confirming that no on-site inspection is required at the Aarau site for this product.
The product manufactured at the Aarau facility will be processed into the final drug that the customer expects to be approved in the USA in November 2021.
“This positive inspection result from the FDA is a demonstration of our team’s commitment to the highest level of quality. This result continues a series of positive inspections by the FDA at CARBOGEN AMCIS reinforcing our successful audit history. I would like to congratulate everyone for the great effort and thank our customer for their trust in our company.” said Mark Griffiths, Dishman Carbogen Amcis Group CEO.
Opened in 1994, the Aarau facility has the flexibility to accommodate a wide range of projects, be it API or analytical. The site is centrally located in Switzerland between Zurich, Basel and Lucerne, 38km away from the headquarters in Bubendorf.
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Total of 16 vessels from 16 L to 630 L
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Swiss Medic approved site
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Fully cGMP compliant
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Specialized Chromatography Group
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Strong Analytical Capabilities & Specialties Lab
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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.