ten23 health has announced that its Quality Control (QC) laboratories have received acceptance from the U.S. Food and Drug Administration, marking an important regulatory milestone for the company’s testing capabilities. This recognition builds on the Swissmedic Good Manufacturing Practice (GMP) certifications already obtained for its QC facilities and further strengthens ten23 health’s position as a reliable partner for global pharmaceutical and biotech clients.
The FDA acceptance concerns ten23 health’s QC laboratories that perform analytical testing for sterile pharmaceutical products destined for the U.S. market. Combined with existing GMP approvals, these laboratories now operate under a framework that meets both Swiss and U.S. regulatory expectations for commercial products. This evolution confirms the robustness of ten23 health’s quality systems and processes for release and stability testing.
Dual certification unlocked
The FDA acceptance applies specifically to the QC laboratories in Basel and Visp, which handle analytical testing for release and stability of commercial products. These sites now meet both U.S. and Swiss regulatory standards, providing clients with validated testing capabilities aligned to international GMP requirements. This positions ten23 health to support quality assurance for injectable medicines targeting global markets.
Commercial supply enabled
With FDA-accepted QC labs in Basel and Visp, ten23 health can integrate testing services directly into commercial product supply chains for the U.S. This includes method transfer, routine release testing, and stability programs essential for regulatory compliance and product lifecycle management. Clients benefit from streamlined validation processes without the need for additional site-specific qualifications.
Basel-Visp synergy
The dual-site QC infrastructure in Basel and Visp allows ten23 health to pair analytical testing with its development, fill-finish, and manufacturing services. This setup supports end-to-end workflows where QC data from these accepted labs feeds into batch release decisions and ongoing stability monitoring for sterile injectables.
Signal for Valais
This step gives additional international visibility to the expertise hosted within the Valais life sciences environment. The FDA acceptance of QC laboratories located in the region, as well as in Basel, underlines that infrastructure in Valais can meet the standards required to serve global pharmaceutical markets. Without changing the scope of the announcement itself, this milestone contributes to consolidating the image of Valais as a competent and trusted base for high‑quality, compliant services in the life sciences field.
