CARBOGEN AMCIS announces successful FDA and Swissmedic inspections of its facilities in Switzerland
BUBENDORF, Switzerland (02 june 2023) – 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 its headquarters in Bubendorf, Switzerland and a Swissmedic routine inspection at Bubendorf, Aarau and Neuland, Switzerland.
From December 8th - 16th 2022, a seven-day surveillance inspection was undertaken by the U.S. FDA at its facility in Bubendorf, Switzerland. The inspection concluded with a Form 483 listing two observations. CARBOGEN AMCIS has initiated measures to correct the observations, which the FDA has accepted.
In January 2023, The Swiss Agency for Therapeutic Products, Swissmedic, successfully concluded their routine inspection of CARBOGEN AMCIS’ Bubendorf, Aarau and Neuland sites with no critical observations. The inspection included Bubendorf’s newly enhanced manufacturing division. Swissmedic validated CARBOGEN AMCIS’ existing GMP manufacturing authorization of all three sites for an unlimited period without restrictions.
Pascal Villemagne, CEO of CARBOGEN AMCIS in Europe, said: “The outcome of these inspections further highlights the full commitment of our team to deliver quality products and services to our clients.
I would like to congratulate everyone for their contributions to our success and the continuous support from our customers to deliver high value solutions to patients around the world.”
CARBOGEN AMCIS’ Swiss-based facilities focus on the development, process optimization and commercial supply of API products. They also accommodate bioconjugation manufacturing, highly potent manufacturing, intermediate-scale production, chromatography and freeze-drying.
Martin Schneider, Director Quality & ESH and Chief Quality Officer of CARBOGEN AMCIS, said: “The result of these new inspections adds to the series of positive inspections across our facilities and reinforces our successful history of FDA and Swissmedic inspections.”
All four Swiss-based CARBOGEN AMCIS’ facilities manufacture products according to cGMP standards and are routinely inspected by legal and regulatory authorities. The facilities underwent successful Swissmedic inspections in 2015, 2017, 2018, 2020 and 2022, and the Bubendorf facility underwent successful FDA inspections in 1997, 2002, 2008, 2011, 2014 and 2017.
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 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.