Global pharmaceutical chemistry leader Cambridge Major Laboratories Europe, B.V. (CML-Europe) is pleased to announce the successful completion of its first Food and Drug Administration inspection. The inspection included a pre-approval inspection and general quality systems audit and concluded with no Form 483 being issued.
“This successful FDA inspection represents a major milestone for the CML-Europe facility,” said Peter van Tilburg, President of CML-Europe. “We place Quality above all else, and I am so proud that the dedication and performance of the CML-Europe team resulted in this successful outcome."
The successful inspection is the culmination of efforts to demonstrate CML-Europe’s ability to supply world-class development services and niche commercial API's to its growing customer base.
“CML-Europe will always be committed to quality and strong leadership, and this commitment is evidenced by two significant recent hires,” said Peter van Tilburg. In September, 2013, CML-Europe hired Dr. Marcel Schreuder Goedheijt as Director Operations, and Mr. Jan Douwstra as Head of Production. Dr. Schreuder Goedheijt brings a wealth of chemical pharmaceutical and business experience from his previous positions at DSM, DSM Pharma Chemicals, MSD and Diosynth BV. Mr. Douwstra held previous positions at the Academic Medical Centre, Amsterdam and St. Radboud University Medical Centre, Nijmegen, as well as Abbott Healthcare B.V., Solvay Pharmaceuticals B.V. Weesp, and Smit & Zoon B.V. Amersfoort.Cambridge Major Laboratories, Inc. announced its intent to merge with AAIPharma Services, Corp. on October 2, 2013. About Cambridge Major Laboratories, Inc. Cambridge Major Laboratories, Inc. (CML) is a leading global chemistry outsourcing partner to the pharmaceutical and biotechnology industries. The Company produces pharmaceutical intermediates and Active Pharmaceutical Ingredients (API), from early preclinical development to commercial manufacturing. Operating from FDA-inspected facilities in the US and Europe, CML is organized along five key Centers of Excellence, including: Process Chemistry, GMP Manufacturing, Solid State Chemistry, Analytical Services, and Quality/Regulatory Compliance. CML is a portfolio company of American Capital, Ltd. (NASDAQ: ACAS).