API small molecule and ADC contract manufacturer Axplora's Chasse-sur-Rhône, France CDMO site has passed its latest on-site inspection by the French National Agency for Medicines and Health Products Safety (ANSM).
This achievement confirms the site's full compliance with current cGMP practices, with the company receiving no critical remarks or 483 observations.
This is the ninth successful inspection at Axplora's Chasse-sur-Rhône site since 2003, which produces more than 30 clinical and commercial small molecules for its European pharmaceutical clients, as well as those further afield.
“This achievement is the result of our team’s quality, safety and operational excellence mindset,” said Daniel Lasanow, Site Director.
“We are proud to provide a trusted, fully compliant environment that supports our customers’ API development from early-phase projects through to commercial supply.”
Axplora's Chasse-sur-Rhône site plays a central role in Axplora’s integrated European CDMO network, which comprises of five sites across the continent.
Together, these facilities deliver custom API and intermediate development and manufacturing services, providing a robust supply for pharmaceutical customers at small or large-scale quantities.
“Our quality mindset is deeply embedded at every level of our operations,” added Sébastien Bosc, Head of Quality Assurance at Chasse-sur-Rhône.
“These inspection results are not only a recognition of our robust systems, but also a validation of the ongoing investment and continuous improvement we are pursuing so can meet and exceed regulatory expectations.”
