SwissMedic Authorizes Production of Commercial Drugs in Canton Aargau4 June 2012
BUBENDORF, Switzerland (June 4, 2012) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its two sites in canton Aargau, Switzerland have obtained the legal authorization from SwissMedic, the Swiss Agency for Therapeutic Products, to manufacture drug substances for commercial scopes. The licence was granted by the Swiss Agency upon successful cGMP (current Good Manufacturing Practices) inspections at both sites in March.
Before this authorization, the cGMP sites in Aargau were exclusively focused on process research and development of early phase drugs and on the rapid supply of APIs for toxicology and early phase clinical trials.
Currently, CARBOGEN AMCIS manufactures commercial APIs under cGMP from all its three sites in Switzerland:
Located 30 km west of Zurich, the Aarau site operates since 1994 and features 16 general reactors from 16 L up to 640 L operating at temperatures comprised between -100º to 160ºC. Typical batch sizes here range from few kilos up to 50 Kg. The site accommodates a staff of 85 employees.
Hunzenschwil (Neuland), Switzerland
The Neuland facility opened in 2000 and houses approximately 40 employees. The site has 14 general reactors from 6 L up to 630 L for the manufactures commercial API. The reactors operate at temperatures between -100º to 160ºC. Typical batch sizes here range from few kilos up to 50 Kg.
Operating since 1987, the Bubendorf features 27 general reactors from 50 L to 2,500 L and four reactors from 100 L to 250 L dedicated to highly-potent compounds. Reactors operate at temperatures between –80ºC and +160ºC and pressures from 1 mbar to 25 bar. Typical batch sizes here range up to 200 Kg and, for highly-potent APIs, up to 35 Kg. The site supports 160 employees.
The positive SwissMedic inspection at Aargau follows the previous FDA inspection at the Bubendorf site announced by the company earlier this year.
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 Group (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, China and India.
Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland