BUBENDORF, Switzerland (July 21st, 2017) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced the renewal of cGMP certificates, and the successful completion of Swissmedic inspections at three of its sites.
Swissmedic conducted inspections (general surveillance audits) of three of CARBOGEN AMCIS' facilities – Bubendorf, Aarau and Neuland – in late April and early May, 2017. No significant concerns were discovered during the inspections which resulted in the renewal of the GMP-certificates, granted for all three sites.
"The successful inspections of the Bubendorf, Aarau and Neuland facilities reinforce our commitment to the highest quality standard in Switzerland and worldwide,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS. “The three facilities meet all expectations related to cGMP and quality for API development and manufacturing services to support our customers. We are extremely pleased to continue our long-standing track record of successful inspections and regulatory audits.”
“Our company is continuously growing and expanding its operations, particularly at our facilities in Bubendorf, Aarau and Neuland. A positive audit is a critical component of our expansion process. We remain deeply committed to excellence, so quality is crucial to our success and our customer's satisfaction," said Mark Griffiths, CEO, Dishman Group.
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 vessels from 1 L to 2500L
- FDA 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
Aarau and Neuland facilities
The Aarau and Neuland facilities have the flexibility to accommodate any project, be it API or analytical. They are located 10km away from each other and constitute a team of more than 200 employees. Site information at-a-glance:
More than 30 vessels from 10 L to 630 L
- FDA inspected
- Fully cGMP compliant
- Specialized Chromatography Group
- Strong Analytical Capabilities and Specialties Lab
- Across all Site spanning Hazard and 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 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.