ten23 health supports commercial product testing for US customers following FDA approvals

Key Highlights

• The FDA approval relates to a U.S. customer’s commercial product, and recognizes that ten23 health’s Basel (BASE) and Visp (VIVA2) QC labs can be used to perform GMP-compliant analytical release testing and stability studies, including microbiology, content, purity, identity and pharmacopeial testing.
• This milestone further confirms ten23 health’s vertically integrated offerings — from formulation and process development to fill/finish and now FDA-approved QC testing — supporting clients across the full lifecycle of injectable and sterile drug products.
• The achievement underscores ten23 health’s commitment to rigorous regulatory standards, quality assurance, and scientific expertise, aligned with its mission to serve Patients, People, Planet.

“We are delighted to have achieved FDA acceptance of our QC laboratories, on top of our Swissmedic GMP certifications,” affirms Hanns-Christian Mahler, CEO of ten23 health. “Our pharmaceutical and biotech clients can now rely on our analytical team and infrastructure to meet U.S. regulatory expectations—without requiring duplicate arrangements elsewhere. Our testing and QC offerings, integrated with our development and manufacturing activities, will reduce complexity, accelerate timelines and help to supply products to patients in the U.S.”

“Recognition by the FDA is a great reward for the hard work of everyone in our Quality Control team, and an important signal that we can meet the standards of the U.S regulatory agency. We are excited to grow the business as ten23 health becomes more international,” remarks Ivana Heckel, Head of QC at ten23.

Strategic Impact and Client Benefits

• Full range of service offering: ten23 health offers a truly integrated platform formulation, process development, sterile manufacturing and analytical testing — all under one roof.
• Regulatory readiness: Clients leveraging ten23 health’s services can now benefit from QC standards which align with FDA expectations for clinical and commercial submissions.
• Quality & sustainability: Reflecting its purpose-driven agenda, ten23 health continues to invest in high-quality infrastructure and sustainable operations, thereby offering not only technical excellence but also responsible manufacturing practices.
• Global access, Swiss Excellence: Based in Basel and Visp, Switzerland, ten23 health delivers to clients around the world while leveraging Swiss regulatory standards, precision and culture of quality.