Cambridge Major Laboratories Europe, B.V. Announces Successful FDA Inspection At Weert Facility
21 10월 2013 - 10:00PM
Business Wire
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).
For more information on the company, visit www.c-mlabs.com.
About AAIPharma Services Corp.
AAIPharma Services Corp. is a leading provider of contract
services that support all phases of drug development. The company’s
wide array of capabilities includes analytical and formulation
development, material testing services, microbiology, clinical and
commercial contract manufacturing, pharmaceutical packaging, and
stability services. Serving more than 600 clients around the globe
and headquartered in Wilmington, N.C., AAIPharma is a portfolio
company of Water Street Healthcare Partners, a strategic investor
focused exclusively on health care.
For more information on the company,
visit www.aaipharma.com.
Media Contacts:CMLKim Black-Washington,
+1-262-955-4715k.black-washington@c-mlabs.comorAAIPharma Services
Corp.Jeff A. Parrott, Ph.D.media_relations@aaipharma.comRelated
Links:Cambridge Major Laboratories Home
Pagehttp://www.c-mlabs.com/AAIPharma Home
Pagehttp://www.aaipharma.com/
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