Axplora has confirmed the successful outcome of its latest inspection by the French National Agency for Medicines and Health Products Safety (ANSM) at its Chasse-sur-Rhône contract development and manufacturing (CDMO) site.

The audit, conducted in February 2025, resulted in no critical observations, reinforcing the site’s consistent record of compliance with current Good Manufacturing Practices.

This marks the ninth successful regulatory inspection for the Chasse-sur-Rhône site since 2003, highlighting Axplora’s sustained commitment to regulatory standards and operational consistency.

“This achievement is the result of our team’s quality, safety, and operational excellence mindset, all delivered with reliability, speed, and efficiency,” 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.”

The Chasse-sur-Rhône facility manufactures more than 30 clinical and commercial small molecules and plays a central role in Axplora’s integrated European CDMO network. The company operates five sites across Europe, each with a 100 percent regulatory inspection success rate. This network enables flexible, scalable manufacturing capabilities for pharmaceutical partners working across a product’s lifecycle, from early development to full commercialisation.

“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.”

Axplora, formed through the integration of PharmaZell, Farmabios, and Novasep CDMO, provides API manufacturing services to over 900 pharmaceutical and biotech companies worldwide. The company has expertise in complex chemistry, highly potent compounds, purification technologies, and antibody-drug conjugates.

With nine manufacturing sites across Europe and India, Axplora offers multi-site capacity for active pharmaceutical ingredient production and supply.