-   History


1997:
Foundation of ABX GmbH. Vision: Production of PET Precursor – Diprenorphine
1998:
Start with own laboratory ( 30 sqm ). Start with CRO business
2001:
Start of kit production in new facilities in Robert-Bosch-Strasse
2002:
Split off of CRO business into independent ABX-CRO GmbH. Purchase of facilities in Heinrich-Glaeser-Strasse 10 - 14 and start of reconstruction
2003:
Chemical labs and clean rooms in Heinrich-Glaeser-Strasse 12 operational
2004:
Successful audit by “Regierungspraesidium Dresden” for GMP production
2005:
Successful audit by FDA for GMP compliance for APIs. Successful audit by “Regierungspräsidium Dresden” for license of wholesalers
2006:
Change in ownership - new owner: CIL / Cambridge Isotope Laboratories, Inc. (USA), subsidiary of Otsuka Pharmaceuticals (Japan))
2007:
Hot (radiosynthesis) laboratory for R&D in Heinrich-Glaeser-Strasse 10 operational. Re-audit by “Regierungspraesidium Dresden” for GMP production
2008:
Re-audit by FDA for GMP compliance for APIs
2011:
Re-audit by “Landesdirektion Dresden” for GMP production
2012:
Re-audit by FDA for GMP compliance for APIs
2013:
New production building for GMP filling and assembling in Heinrich-Glaeser-Strasse 14 operational. Re-audit by “Landesdirektion Dresden” for the new ABX GMP facilty