Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today its Hunzenschwil (Neuland), Switzerland API manufacturing site has successfully completed a U.S. Food and Drug Administration (FDA) pre-approval inspection.
The four-day, pre-approval inspection was undertaken by an FDA investigator from July 8-11, 2019. The inspection was concluded with no Form 483’s filed, thus confirming that no critical or major observation was raised during the inspection. The auditor will recommend the approval of API for which the audit was conducted. The final Establishment Inspection Report (EIR) is expected within the next six months.
“This latest pre-approval confirms the total commitment to quality and teamwork of each of our colleagues working across the entire company. Our team successfully completed the audit with the best possible result, thus ensuring our Client can progress towards bringing an important new treatment to patients,” said Mark Griffiths, Dishman Carbogen Amcis Group CEO. “I would like to congratulate everyone for the teamwork and the effort provided, and thank our clients for their continued trust in our Company.”
“This result is a continuation of a series of positive inspections across CARBOGEN AMCIS, reinforcing our successful history of regular FDA (11), Swissmedic (each Swiss site inspected every 2-3 years), Korean FDA (2) and ANSM (2) audits,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS.
“The successful audit is invaluable for our customers and the continued culture of quality for our business,” commented J.R. Vyas, Chairman of the Dishman Group. “Our priority is to put patients’ safety first and that is what drives us every day. All sites of the group are involved in the process of continuously improving our quality performance, and I encourage everyone to keep this commitment at the forefront of their daily activities.”
The Hunzenschwil facility is one of CARBOGEN AMCIS’ four sites to offer development and manufacturing facilities for highly potent compounds. It manufactures products according to cGMP standards and is routinely inspected by Swissmedic, the FDA and external customers. Located in the district of Lenzburg in the canton of Aargau 25 km west of Zurich, the manufacturing site was opened in 2000.
Site information at-a-glance:
- Analytical services
- API and intermediate stability studies
- API process research and development
- Small-scale commercial API supply
- Crystallization laboratory
- FDA, MFDS and Swissmedic inspected
CARBOGEN AMCIS AG (www.carbogen-amcis.com)