CARBOGEN AMCIS AG, a subsidiary of Dishman Carbogen Amcis Limited, has announced the successful completion of a Swissmedic inspection at its Vionnaz facility in Switzerland. This achievement reaffirms the site’s compliance with stringent regulatory and Good Manufacturing Practices (GMP) standards.
The routine inspection, conducted by the Swiss Agency for Therapeutic Products (Swissmedic) from November 13-14, 2024, focused on the Quality Management System for the development and production of Highly Potent Active Pharmaceutical Ingredients (APIs). The inspection also reviewed analytical and quality control processes. Following the two-day audit, the site’s GMP certification was renewed, continuing its unbroken record of compliance since the first inspection in 2015.
Acquired in 2014, the Vionnaz facility specializes in small-scale production of Highly Potent APIs (up to category 5), including warheads and linkers for antibody-drug conjugates (ADCs). It boasts state-of-the-art infrastructure with three process development laboratories, a QC lab, production units equipped with reactors up to 30 liters, preparative chromatography systems, and pilot-scale freeze dryers.
This milestone reflects CARBOGEN AMCIS’s unwavering commitment to maintaining the highest regulatory standards and reinforces its position as a leader in pharmaceutical process development and API manufacturing.
