DRAXIS Accepted by FDA to Manufacture Solid Dosage Form Products; Approval Opens Doors to Additional Markets in the U.S.Business Editors & Health/Medical Writers MISSISSAUGA, Ontario--(BUSINESS WIRE)--Sept. 17, 2002 DRAXIS Health Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :DAX) (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DRAX) has received a letter of acceptance from the U.S. Food and Drug Administration (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. ) for DRAXIS Pharma Inc., its contract pharmaceutical manufacturing subsidiary, to manufacture solid dosage form A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. products, such as capsules and tablets, for the U.S. market. This FDA acceptance positions DRAXIS Pharma for continuing expansion of its customer base for the production of pharmaceutical products in the U.S. and other international markets. The notice from the FDA follows an inspection of the Company's pharmaceutical manufacturing facility in Kirkland, Quebec Kirkland is a municipality on the Island of Montreal in southwestern Quebec, Canada. As of October 2005, the population was 21,735. It is named after Dr. Charles-Aimé Kirkland, a Quebec provincial politician. during June 2002 relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the manufacturing portion of a regulatory submission by a DRAXIS Pharma customer. The FDA's resulting Establishment Inspection Report covered the manufacturing requirements for a solid dosage product and incorporated a general cGMP (current Good Manufacturing Practices) review of associated production processes and laboratory systems. DRAXIS Pharma was found to be operating in a state of control and the facility was classified as acceptable. "Establishing and maintaining the highest standards of cGMP regulatory compliance is central to our long term strategic plan for growing our businesses in the international marketplace," said Dr. Martin Barkin, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of DRAXIS. "This new FDA approval of our solid dosage form operation significantly enhances our ability to continue to grow our contract manufacturing business and to increase the capacity utilization Capacity Utilization measures the rate at which a firm makes use of their capital productive capacities, such as factories and machinery. Capacity Utilization generally rises when the economy is healthy and falls when demand softens. of our manufacturing facilities. As a result of receiving several FDA manufacturing site approvals for its Kirkland operations, DRAXIS now has the capability to offer U.S. customers full service, cGMP compliant contract manufacturing services for a wide range of specialized pharmaceutical products including: -- sterile lyophilized (freeze-dried) products for injection -- sterile liquid injectables in both vials and ampoules -- solid dosage form products in the form of capsules and tablets -- radiopharmaceutical products About DRAXIS Pharma Inc. DRAXIS Pharma Inc. is a contract pharmaceutical manufacturer with capabilities in a broad range of dosage forms, specializing in sterile and sterile lyophilized ly·oph·i·lize tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es To freeze-dry (blood plasma or other biological substances). [lyophil(ic) + -ize. products. Operating out of a cGMP-compliant 242,000 square-foot facility located in Montreal, Canada, DRAXIS Pharma manufactures pharmaceutical products for DRAXIS, as well as 15 other pharmaceutical clients for many international jurisdictions. About DRAXIS Health Inc. DRAXIS Health Inc. is a specialty pharmaceutical company focused on the development, production, marketing and distribution of radiopharmaceuticals (DRAXIMAGE) and the provision of contract pharmaceutical manufacturing services, specializing in liquid and freeze-dried injectables and other sterile products (DRAXIS Pharma). Except for historical information, this news release contains certain forward-looking statements within the meaning of 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 as amended, which involve risk and uncertainties that may cause actual results to differ materially from the statements made. Such factors include, but are not limited to, timely regulatory approval of the Company's products, the ability to obtain and enforce effective patents, the establishment and maintenance of new corporate alliances, compliance with appropriate governmental regulations, and other risks detailed from time-to-time in the Company's filings with the US Securities and Exchange Commission and Canadian securities authorities. The Company does not undertake to update such forward-looking statements to reflect new information, later events or developments. |
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