BUBENDORF, Switzerland (October 11th, 2017) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Bubendorf, Switzerland API manufacturing site has successfully completed a routine U.S. Food and Drug Administration (FDA) inspection.
The cGMP (current Good Manufacturing Practices) Audit was completed over five days, from September 4th to 8th, 2017. The inspection consisted of an analysis of all Quality Systems, processes and procedures related to the development, validation and manufacture of APIs and highly-potent APIs at the Bubendorf site. The inspection was concluded without major or critical observations or Form 483’s, thus confirming that no concerns were discovered during the inspection. The Final Establishment Inspection Report (EIR) is expected in the next six months.
“The successful FDA inspection of our Bubendorf site, proceeded by two successful inspections of our two other sites in Aarau and Neuland in 2015, reinforces CARBOGEN AMCIS’ commitment to delivering the highest standard of quality that our customers expect from us” said Mark Griffiths, CEO Dishman Group. “We look forward to sharing this exciting news with our customers at CPhI on October 24-26, 2017, in Frankfurt, Germany.”
“I am delighted about this positive outcome of the FDA inspection at Bubendorf,” said Mr. J.R. Vyas, Chairman and Founder of the Dishman Group. “This is a great achievement that rewards many years of dedication and commitment to quality by each of our team members, thus maintaining our long track record of successful regulatory inspections and audits.”
The Bubendorf facility manufactures products according to cGMP standards and is routinely inspected by SwissMedic, the FDA and external customers. The facility underwent successful FDA inspections in 2002, 2008, 2011 and 2014.
Operating since 1987, the Bubendorf facility is CARBOGEN AMCIS’ headquarters. The site employs more than 250 people. Site information at-a-glance:
• More than 30 reactors from 1 L to 2500L
• FDA and Swiss Medic inspected
• State of the Art ADC Laboratories
• HiPo manufacturing up to 100 kg scale, up to Cat. 4+
• cGMP Chromatography to multi 100 kg scale
• Late Phase and Commercial Supply of API
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.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.