Axplora’s Chasse-sur-Rhône site successfully passes its ninth consecutive regulatory inspection
Published on June 04, 2025
Axplora, a global leader in API small molecule and ADC (antibody-drug conjugate) manufacturing, is proud to announce that its Chasse-sur-Rhône CDMO site in France has successfully passed its latest on-site inspection by the French National Agency for Medicines and Health Products Safety (ANSM). Conducted in February 2025, the inspection confirmed the site’s full compliance with current Good Manufacturing Practices (cGMP), with no critical remarks or 483 observations.
This achievement marks the ninth successful inspection at Chasse-sur-Rhône since 2003 and underscores Axplora’s unwavering commitment to regulatory rigor and operational reliability.
“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.”
With more than 30 clinical and commercial small molecules, the Chasse-sur-Rhône site plays a central role in Axplora’s integrated global network, which includes nine sites with a 100% regulatory inspection success rate. Together, these facilities deliver world-class capabilities for custom development and manufacturing of APIs and intermediates. They also ensure flexibility, scalability, and robust supply for pharmaceutical innovators worldwide, from small-scale to large-scale quantities, throughout the entire product lifecycle.
“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.”
This milestone reinforces Axplora’s position as a trusted CDMO partner, dedicated to delivering high-quality, compliant, and efficient manufacturing solutions that help pharmaceutical innovators bring life-changing therapies to patients faster.
About Axplora
Axplora is a trusted manufacturing partner to over 900 of the world’s leading pharmaceutical and biotech companies, formed from the integration of PharmaZell, Farmabios, and Novasep CDMO—three industry leaders with decades of experience in pharmaceutical manufacturing. Axplora delivers high-quality, reliable, and sustainable solutions across the pharmaceutical value chain.
With deep capabilities in complex chemistry and industrial manufacturing combined with an agile, explorer’s mindset, Axplora supports pharmaceutical and biotech companies in developing and producing life-changing therapies. PharmaZell and Farmabios are renowned for their expertise in active pharmaceutical ingredients (APIs), highly potent compounds, and regulatory excellence, while Novasep CDMO is a leader in small molecule and antibody-drug conjugates (ADCs) manufacturing while being a pioneer in purification technologies.
Axplora operates 9 API manufacturing sites across Europe and India, providing multi-site capacity to partners worldwide.
For more information, visit www.axplora.com
Press contact:
Will Frost (UK/US) Thomas Goldberg (Europe)
Phone: +44 (0)7799652421 +33 (0)6 03 78 55 63
