Covance Clinical Research Unit in Leeds Opens New GMP Pharmacy
Leeds, Yorkshire, United Kingdom, 21 February 2005 Covance Inc. ( NYSE: CVD ) announced today that it has completed construction and validation of a fully compliant cGMP (current good manufacturing practices) pharmacy at its clinical research unit (CRU) in Leeds. One of only a few such facilities in the UK, this new pharmacy meets cGMP requirements defined by the European Union Clinical Trials Directive (EUCTD) for the manufacture of all Investigational Medicinal Products.
Joe Herring, President and Chief Executive Officer of Covance, joined the Leeds CRU management today in a ribbon cutting ceremony to open the new pharmacy. "Covance continues to invest in our Leeds CRU so that we can provide outstanding clinical pharmacology support to our clients over the long term. This cGMP pharmacy demonstrates our commitment to global regulatory compliance, and positions Covance for continued growth" said Mr. Herring.
To meet the needs of pharmaceutical companies outside the European Union, the new pharmacy has been granted a Manufacturing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA). Covance has eliminated the need for additional logistics since a Qualified Person, as required by the implementation of the EUCTD, ensures that both manufacturing site and imported batches meet European Union standards of cGMP prior to release. The pharmacy has also undergone a successful inspection by the MHRA to confirm cGMP compliance.
Additional new services available for clients include the preparation of aseptic doses for intravenous administration, and cGMP-compliant small-scale manufacture of fit-for-purpose formulations for first-in-human clinical studies.
Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1 billion, global operations in 18 countries, and approximately 6,700 employees worldwide. Information on Covance's products and services, recent press releases , and SEC filings can be obtained through the Covance website.
Statements contained in this press release, which are not historical facts, are forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All such forward-looking statements including the statements contained herein regarding anticipated trends in the Company's business are based largely on management's expectations and are subject to an qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, the Company's ability to continue to attract and retain qualified personnel, the fixed price nature of contracts or the loss of large contracts, and other factors described in the Company's filings with the Securities and Exchange Commission.
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