ABX Milestones

From a small Lab with 5 employees 
to a worldwide Trusted Partner
 

1997

Foundation of ABX

ABX was founded as a manufacturer and supplier of small-molecule PET tracer chemicals, laying the foundation for its future leadership in molecular imaging and radiopharmaceutical development.
2004

First FDA Inspection Successfully Completed

ABX successfully underwent its first FDA site inspection, demonstrating its commitment to international quality and compliance standards.
2006

Integration into the CIL and Otsuka Group

ABX became part of Cambridge Isotope Laboratories (CIL) and Otsuka, strengthening its global presence and expanding its capabilities in healthcare and life sciences.
2007

Radiochemistry Facility and First Cyclotron Commissioned

ABX commissioned its dedicated radiochemistry facility and installed its first cyclotron (10 MeV), significantly expanding its capabilities in radionuclide production and radiopharmaceutical manufacturing.
2011

First GMP Peptide Production

ABX successfully produced its first GMP-compliant peptides, marking an important milestone in the development and manufacturing of high-quality pharmaceutical products.
2014

Exclusive PSMA and Peptide Licensing Agreement

ABX secured a licensing agreement with DKFZ Heidelberg for PSMA and peptide technologies, paving the way for innovations in targeted diagnostics and therapy.
2017

Manufacturing Authorization for Radiopharmaceuticals

ABX received manufacturing authorization for radiopharmaceuticals, supporting clinical and commercial production programs, including contributions to landmark projects such as the VISION trial.
2021

Approval of Radelumin® in France

ABX achieved approval of [¹⁸F]PSMA-1007 in France under the brand name Radelumin®, representing a significant advancement in prostate cancer diagnostics.
2022

Opening of Advanced GMP Laboratories

ABX commissioned state-of-the-art GMP laboratories dedicated to the development and production of APIs, precursors, and reference standards, further strengthening its manufacturing excellence.
2023

Positive European MRP for Radelumin®

Radelumin® received a positive outcome through the European Mutual Recognition Procedure (MRP), enabling additional marketing authorizations across multiple European countries.
2024

Commercial Manufacturing Authorization for Radelumin®

ABX obtained manufacturing authorization for the production and supply of Radelumin® to local healthcare institutions and hospitals.
2025

Expansion of Cyclotron Capacity

The installation of a new 30 MeV cyclotron significantly expanded our production capabilities, enabling increased output and supporting the growing global demand for radioisotopes and radiopharmaceuticals.

From Phase I to Market
End-to-End Manufacturing Capabilities EstablishedThe launch of fully integrated radiopharmacy production facilities enables seamless support throughout the entire product lifecycle, from early-stage clinical development and Phase I-III trials to commercial-scale manufacturing and supply.

Growing Team, Growing Impact
Our team expanded to more than 400 employees, reflecting our continued growth and commitment to advancing innovation in radiopharmaceutical manufacturing and patient care.
2026

Expansion of the Radeberg Production Site

Construction commenced on the expansion of our Pillnitzer Street facility, adding new manufacturing and development capacities to support future growth and increasing market demand.

Strategic Acquisition of TRIMT
The acquisition of TRIMT significantly expanded our product portfolio, strengthened our expertise across the radiopharmaceutical value chain, and enhanced our ability to deliver innovative solutions to customers worldwide.
Today

Driving Innovation in Radiopharmaceuticals Worldwide

Today, ABX is a globally recognized partner for radiopharmaceutical development, GMP manufacturing, and the supply of high-quality products enabling precision diagnostics and targeted therapies worldwide. With the Radelumin network now spanning more than 30 CMO sites across the globe, we are expanding access to advanced radiopharmaceutical manufacturing and helping bring innovative therapies closer to patients in more regions than ever before.