CARBOGEN AMCIS, an API manufacturing and process development organisation, has successfully completed two inspections by the US Food and Drug Administration at its Neuland and Aarau sites.
These routine assessments were carried out over five consecutive days in Neuland and Aarau, with the investigators finding no Form 483 observations or critical findings, affirming that no action for improvement was necessary.
The Neuland facility, which is located in Hunzenschwil, Switzerland, specialises in both drug development and medium-scale cGMP manufacturing.
It is the company’s second site which hoses a number of laboratories designed to develop potent compounds for drug products, and can handle analytics, API stability studies and API process research & development.
The Aarau facility, which has been around since 1994, has a similar focus to the Neuland facility, but is equipped with a number of technologies such as solid-state analysis tools and chromatography separation machines.
The primary activities of the site are API process research and development, small-scale API production and analytical services.
“The successful inspections at our Aarau and Neuland sites highlight CARBOGEN AMCIS’s consistent track record of high-quality development and manufacturing. This achievement reinforces our commitment to delivering the superior quality our customers expect,” said CEO of CARBOGEN AMCIS, Pascal Villemagne. “Our Quality Team collaborates closely with every CARBOGEN AMCIS facility to uphold a robust and reliable quality policy across the company.”
