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January 17, Germantown, WI USA: Cambridge Major Laboratories today announced it has commenced GMP operations in its new, state of the art facility in in Germantown Wisconsin. The 50,000 square foot cGMP facility represents the future of Cambridge Major and underscores the company’s continuing strength in the custom chemicals marketplace.

Coming off of a 50% growth in business in 2004, Cambridge Major has accelerated its transition plan into the new site. The plan involved first commissioning and qualifying all HVAC, common utilities and GMP kilo lab production suites. This phase of the work has been completed and GMP manufacture is underway. Phase 2 of the transition involves the commissioning and qualification of the plant areas which is currently in an advanced stage of completion.

“Due to our remarkable growth in 2004, the pressure was on to transition GMP operations to the new, larger site as soon as possible”, said Brian Scanlan, Vice President of Corporate Development at Cambridge Major. “We have moved rapidly to qualify the site, ensuring that all possible systems and equipment are in compliance for production of GMP materials, both clinical and commercial API’s. Teams have worked the past 6 months mapping out, testing, and qualifying the entire HVAC system, utilities, and GMP processing suites giving our customers the comfort that our state-of-the-art facility will exceed their expectations on environmental and process controls. Now that our GMP suites are fully qualified, we are focusing our efforts on the plant areas, and we anticipate completion of this in the next 1-2 months.”

Cambridge Major also produces commercial API’s (combination of generics and NCE’s), many in GMP kilo lab suites, and as such these processes are currently being re-validated at the new site ahead of an anticipated FDA inspection later this year.

Cambridge Major Laboratories, Inc. is a service-based chemistry outsourcing partner to the world’s leading pharmaceutical and biotechnology companies, producing pharmaceutical intermediates, API’s, and other fine organic chemicals. Specializing in chemical process development and advanced multi-step organic synthesis, the Company operates a new, state-of-the-art facility near Milwaukee, Wisconsin including process chemistry laboratories, kilo labs, 2 mini-plant suites, 2 main plant bays, and complete analytical laboratories. The Company has been FDA inspected and approved for cGMP manufacturing. Visit us at www.c-mlabs.com.

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