Germantown, WI (May 12, 2011) – Global chemistry leader, Cambridge Major Laboratories (CML) has announced the first FDA inspection and commercial launch of an Active Pharmaceutical Ingredient the Company’s newest facility in Germantown, Wisconsin.
The company’s two manufacturing facilities were the subject of a FDA inspection, which included a pre-approval inspection and a general quality systems inspection of both sites.The FDA inspection represents the first for Cambridge Major’s newest, large scale API manufacturing facility and the seventh inspection over the past nine years. As the company continues to commercialize active pharmaceutical ingredients (API), the number of pre-approval inspections has consistently grown. Currently, Cambridge Major manufactures more than a dozen commercial products including innovative new drugs, generic substances, and medical imaging agents.
“The inspection and subsequent commercial launch is a major milestone for CML which is the first for our new, state of the art large scale API facility. ,” said Scanlan.
“Our objective, as always, is to ensure that our systems are in compliance with FDA requirements. I am very pleased with the outcome of the inspection which demonstrates the full devotion of the management and employees.”
Within 2 months of the successful FDA pre-approval inspection, the FDA announced approval of the product which represents the first commercial product produced in Cambridge Major’s new large scale facility. The approval adds to Cambridge Major’s momentum as the company continues to add employees and services to support its continued growth. “The NDA approval is a significant milestone for our newest facility and a clear sign that we are open for business at the facility. This particular CML facility is truly state-of-the-art and affords CML the capacity for growth and to continue serving customers with the highest level of service,” said Brian Scanlan, President and CEO of Cambridge Major.
About Cambridge Major Laboratories
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 manufacture.
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.
Media Contacts: Mike Payne (Cambridge Major Laboratories) – (262) 366-4950 Ext. 293 or m.payne@c-mlabs.com
