West Pharmaceutical Services Announces European and Asian Manufacturing Sites for Westar RS Pharmaceutical Components.Business Editors/Health/Medical Writers LIONVILLE, Pa.--(BUSINESS WIRE)--June 5, 2003 West Pharmaceutical Services (NYSE NYSE See: New York Stock Exchange : WST WST In currencies, this is the abbreviation for the Samoan Tala. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. ) today announced it will be adding Westar(R) RS processing capabilities to its facilities in Le Nouvion, France; Eschweiler, Germany; and Jurong, Singapore. These sites will be registered with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) and each will be supported by a Drug Master File Drug Master File or DMF is a document prepared by a manufacturer in the pharmaceutical industry and submitted solely at his discretion to the Food and Drug Administration (FDA). There is no requirement by law or FDA regulation to present a DMF. (DMF (Distribution Media Format) A floppy disk format from Microsoft that was used to distribute its software. DMF floppies compressed more data (1.7MB) onto the 3.5" diskette, and the files could not be copied with normal DOS and Windows commands. A DMF utility had to be used. ) with the FDA. Westar RS is the trade name for pharmaceutical components that are washed, may be pre-siliconised and are delivered to pharmaceutical manufacturers ready-to-sterilize. The facilities will adhere to adhere to verb 1. follow, keep, maintain, respect, observe, be true, fulfil, obey, heed, keep to, abide by, be loyal, mind, be constant, be faithful 2. applicable Current Good Manufacturing Processes (CGMP) requirements and will produce components meeting the same specifications for bacterial endotoxin Endotoxin A biologically active substance produced by bacteria and consisting of lipopolysaccharide, a complex macromolecule containing a polysaccharide covalently linked to a unique lipid structure, termed lipid A. , bioburden and particulate levels as for ready-to-sterilize components processed at West's facility in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The extensive validation of the Westar RS process complies with European regulatory requirements and assures consistently high quality products. "The Westar RS process is unique in that it was developed in the United States and has been widely integrated into our customers' processes there for more than five years," said Robert Keating, President of West's Pharmaceutical Services Division, Europe and Asia. "We are pleased that now we can offer regional sourcing to help our European and Asian customers register their products for sales in the U.S." Value to Manufacturers When specifying Westar RS products, manufacturers transfer portions of their component preparation process to West Pharmaceutical Services. West's stringent requirements for quality, validated processes and adherence to CGMPs, assure that product meets defined specifications. The information from the Westar process is documented provided for U.S. and Canadian registrations in site specific DMFs. A letter of authorization to reference the DMF can be obtained from West's U.S. headquarters. About West Pharmaceutical Services West Pharmaceutical Services, Inc. (NYSE: WST) is a global drug delivery technology company that applies proprietary materials science, formulation research and manufacturing innovation to advance the quality, therapeutic value, development speed and rapid market availability of pharmaceuticals, biologics, vaccines and consumer healthcare products. West is the world's premiere provider of standard-setting systems and device components for parenterally par·en·ter·al adj. 1. Physiology Located outside the alimentary canal. 2. Medicine Taken into the body or administered in a manner other than through the digestive tract, as by intravenous or intramuscular administered medicines and an emerging leader in the development of advanced formulation technologies for the transmucosal delivery of drugs. Internationally headquartered in Lionville, Pennsylvania, West supports its partners and customers from 50 locations throughout North America, South America, Europe, Mexico, Japan, Asia and the Pacific and Australia. For more information, visit West at www.westpharma.com. Cautionary Statement Regarding Forward-Looking Information Certain statements contained in this document or in other company documents and certain statements that may be made by management of the Company orally may contain forward-looking statements as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements can be identified by the fact that they do not relate strictly to historic or current facts. They use words such as "estimate," "expect," "intend," "believe," "plan," "anticipate" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or condition. In particular, these include statements concerning future actions, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings All actions that are authorized or sanctioned by law and instituted in a court or a tribunal for the acquisition of rights or the enforcement of remedies. , and financial results. Because actual results are affected by risks and uncertainties, the Company cautions investors that actual results may differ materially from those expressed or implied in any forward looking statement. It is not possible to predict or identify all such risks and uncertainties, but factors that could cause the actual results to differ materially from expected and historical results include, but are not limited to: sales demand, timing of customers' projects; successful development of proprietary drug delivery technologies and systems; regulatory, licensee and/or market acceptance of products based on those technologies; competitive pressures; the strength or weakness of the U.S. dollar; inflation; the cost of raw materials; the availability of credit facilities; and, statutory tax rates. With respect to the explosion and fire at the Company's Kinston, NC plant, the following factors should also be taken into consideration: the timely replacement of production capacity; the adequacy and timing of insurance recoveries for property losses; the unpredictability of existing and future possible litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. related to the explosion and the adequacy of insurance recoveries for costs associated with such litigation; government actions or investigations affecting the Company; the ability of the Company to successfully shift production and compounding capacity to other plant sites in a timely manner, including the successful integration of experienced personnel to other production sites; the extent of uninsured costs for, among other things, legal and investigation services and incremental insurance; and regulatory approvals and customer acceptance of goods under the statute of frauds, is an intelligent acceptance by a party knowing the nature of the transaction. See also: Acceptance from alternate sites. The Company assumes no obligation to update forward-looking statements as circumstances change. Investors are advised, however, to consult any further disclosures the Company makes on related subjects in the Company's 10-K, 10-Q and 8-K reports. Westar(R) is a registered trademark of West Pharmaceutical Services, Inc. |
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