Courroux, Switzerland – Wednesday, 21 January, 2026 Adragos Pharma, a leader in the CDMO industry, is pleased to announce it has received formal approval from the Swiss Agency for Therapeutic Products (Swissmedic) for their newly modernized sterile manufacturing suite, the Beta Line.
This critical milestone follows a comprehensive modernization program in 2024/2025 and a successful Swissmedic site inspection in October of 2025. The approval confirms that the Beta Line meets the highest standards of regulatory compliance and is ready for GMP operations.
The extensive upgrade was a significant undertaking focused on ensuring future-readiness and incorporating the most advanced manufacturing technology, including state-of-the-art Reduced Access Barrier Systems (RABS).
Highlights of the validation and modernization program include:
- 300,000 person-hours of dedicated work
- 150 completed validation activities
- 250 distinct equipment calibrations
- 350 updated Standard Operating Procedures (SOPs)
In addition to regulatory approval, the site’s enhanced capabilities and quality systems were validated during three separate customer audits, all of which yielded positive feedback.
The site is now completing the final Aseptic Process Simulations (APS) to formally demonstrate pristine aseptic control. Upon successful completion, the team will resume manufacturing commercial batches to serve its robust order book.
About Adragos Pharma
Adragos Pharma is an internationally operating contract development and manufacturing organization, headquartered in Munich, Germany. Its declared goal is to expand its existing production network through acquisitions in Europe, North America, and Japan, to attain a global-leading position, and to set new standards in customer service and data centricity. In its buy-and-build growth strategy, Adragos Pharma is supported by FSN Capital, a leading Scandinavian investment firm.
For more information, contact us at publicrelations@adragos-pharma.com
