ABX advanced biochemical compounds      



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

  legal notice       home page       search       email