CARBOGEN AMCIS Announces Successful First FDA Pre-Approval Inspection at Its Vionnaz Site

BUBENDORF, Switzerland (September 28, 2026) — CARBOGEN AMCIS part of the Dishman Carbogen Amcis Group, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce the successful completion of the first U.S. Food and Drug Administration (FDA) Pre-Approval Inspection (PAI) at its Vionnaz facility in Switzerland. The inspection concluded without the issuance of a Form 483.

The FDA conducted the inspection from September 7 to 11, 2026 as part of the regulatory review of a product manufactured at the site. The inspection covered key aspects of the product and its manufacturing process, including manufacturing and batch documentation, process validation, equipment qualification, analytical method validation, cleaning validation, supplier qualification, change control, deviations, corrective and preventive actions (CAPAs), and training.

“This first FDA Pre-Approval Inspection is an important milestone for our Vionnaz site. Its successful completion reflects our continued focus on quality and compliance in the development and manufacture of highly potent APIs. Vionnaz plays an important role in Dishman Carbogen Amcis group’s integrated offering, particularly through its expertise in highly potent compounds,” said Stephanie Schlienger, V.P. Quality & Compliance.

“Completing the inspection without the issuance of a Form 483 is a positive outcome for the site. It reflects the ongoing commitment of our teams to maintaining robust quality standards and meeting our customers’ expectations. I would like to thank everyone who contributed to the preparation and supported the inspection,” said Stephan Fritschi, CEO.

Acquired by CARBOGEN AMCIS in 2014, the Vionnaz facility specialises in the development and small-scale manufacture of highly potent APIs, including warheads and linkers for antibody-drug conjugates. The site has dedicated process development, production and quality control facilities.

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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.imdcal.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.