BUBENDORF, Switzerland (July 13th, 2016) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced, after reception of the Establishment Inspection Report (EIR), that two of its Swiss sites have successfully completed a U.S. Food and Drug Administration (FDA) inspection.
The Pre-Approval Inspections (PAIs) have been completed by an FDA inspector over four days: October 19-20, 2015 in Aarau and October 21 – 22, 2015 in Neuland. The inspections have been concluded with no Form 483 observations or major critical findings, thus confirming that no concerns were discovered during the inspection. The Establishment Inspection Report, received on July 13th, 2016, confirmed this conclusion.
“The successful inspection at the Aarau and Neuland sites underscores CARBOGEN AMICS’ track record of high quality development and manufacturing. These inspections follow a series of successful FDA inspections at our sites. Our Headquarters in Bubendorf have also been successfully inspected by the FDA in 2002, 2008, 2011 and 2014. We have again established the Dishman group’s commitment to consistently fulfill the highest quality requirements for all its sites,” commented Mark Griffiths, CEO Dishman Group. “Our quality team is working closely with every CARBOGEN AMCIS facility to build and reinforce a dependable and strong quality policy across the company.”
“I am delighted about this positive report from the FDA,” said Mr J.R. Vyas, Chairman of the Dishman Group. “This is a great result, which rewards all efforts from our team to maintain the highest level of quality. This also shows our commitment to meet and exceed our customers’ expectations. Since we know that the highest quality standards are essential, we will be well positioned to continue to support our customers’ needs.”
The Aarau and Neuland facilities have the flexibility to accommodate any project, be it API or analytical. They are located 10km away of each other and constitute a team of more than 200 employees.
- Total of 30 vessels from 10 L to 640 L
- Swiss Medic approved sites
- Fully cGMP compliant
- Specialized Chromatography Group
- Strong Analytical Capabilities & Specialties Lab
- Across all Site spanning Hazard & Safety Lab
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 Pharmaceuticals and Chemicals Ltd., Ahmedabad, India.
Dishman Pharmaceuticals and Chemicals Ltd (www.dishmangroup.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.