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May 4, 2004 Germantown, WI USA: Cambridge Major Laboratories announces that two Pre-Approval Inspections, conducted during the weeks of April 19th and April 26th 2004, resulted in no Form 483 observations. The first inspection, performed by the U.S. Food and Drug Administration related to an Active Pharmaceutical Ingredient to be launched in the United States. The second inspection, performed by the Korean Food and Drug Administration, related to a new drug to be launched in that country.

“The results of these inspections underscore Cambridge Major’s commitment to Quality and Regulatory excellence,” said Dr. Michael Major, President and CEO of Cambridge Major Labs.
“Making our way through two concurrent PAI’s by two agencies with no 483’s is truly remarkable. Our QA and QC groups have put in tremendous effort and do whatever is possible to achieve the highest quality standards”.

“Our customers can be assured that Cambridge Major has the experience to successfully develop new drugs from pre-IND through validation and NDA or ANDA, said Brian Scanlan, Vice President of Business Development of Cambridge Major Labs. “Our mission is to be the top small-volume API manufacturer in the country, and solid quality and regulatory groups ensure a foundation to achieve this goal.”

In the past 9 months alone, Cambridge Major has had 4 successful Pre-Approval Inspections, adding to 5 other FDA inspections (PAI’s and General Inspections) over the past several years. The company expects several more FDA inspections over the next 12-18 months on new products the company is developing including NCE’s and Generic Substances.

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 two facilities near Milwaukee, Wisconsin including process chemistry laboratories, kilo labs, a pilot plant, 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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