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FUJISAWA USA SETS UP OPERATIONS GROUP TO MANUFACTURE

Executive Summary

FUJISAWA USA SETS UP OPERATIONS GROUP TO MANUFACTURE multisource drugs for the company's Lyphomed unit and ethical drugs for the Fujisawa Pharmaceutical division, Fujisawa announced in a June 26 release. The operations unit will function as a separate entity from the two drug divisions. Effective July 27, the president of the Operations group will be Theron Odlaug, PhD, who was previously in charge of North American Regional Coordination for Bayer AG. From 1986 to 1991, Odlaug was With Bayer's U.S. subsidiary Miles, most recently as group VP of the diagnostics business unit. Prior to joining Miles, Odlaug worked for Baxter. As head of the Operations group, Odlaug "will be responsible for manufacturing, quality assurance/quality control, formulations, information systems and regulatory affairs," the press release says. The Operations unit will be located at Fujisawa USA's headquarters in Deerfield, III. "The formation of the Operations group is a direct reflection of Fujisawa's commitment to assume a leadership role of superior quality and integrity within the pharmaceutical industry," Fujisawa said. Fujisawa has had continuing problems with meeting good manufacturing practice (GMP) standards. An ongoing internal audit has revealed ANDA discrepancies in Lyphomed applications filed with FDA before 1986 ("The Pink Sheet" June 228 T&G-14). Fujisawa purchased Lyphomed in September 1989. The company has found discrepancies in the ANDAs of at least 11 products and as a result has recalled five of those products (see FDA June 17 and 24 Enforcement Reports, T&G-10). Most of the remaining products are no longer marketed. The ANDA discrepancies were first discovered in an FDA inspection conducted between February and November 1991. Fujisawa said the discrepancies involved Lyphomed's failure to report data that showed the products did not meet stability specifications. In early June, Fujisawa initiated a recall of Adenocard (adenosine), manufactured at a facility in Grand Island, N.Y., because of low fill volume in one lot of vials. In May, five injectable drugs were recalled because of low fill volume. The same month, fluphenazine decanoate injection was recalled because of subpotency. Fujisawa also announced that Nelson Levy, MD/PhD, is the new president of the Fujisawa Pharmaceutical Division. Levy took over from the division's former President Brian Tambi, who joined Ivax in May as exec VP ("The Pink Sheet" May 25, T&G-7). Previously, Levy was CEO of CoreTechs Corp. He also worked at Abbott Labs as VP-pharmaceutical research and director of antibiotics and natural products. The Lyphomed unit also has a new president, John Fowler. He joined Fujisawa USA in January 1991 as assistant to the chairman and CEO and as VP-corporate development. Fowler succeeds former Lyphomed VP- Scientific Affairs Floyd Benjamin, who joined the cellular implant R&D firm TranCel in January ("The Pink Sheet" Jan. 27, T&G-9). Fowler "will be responsible for marketing and sales, customer operations and new business development," Fujisawa said. Before joining Fujisawa, Fowler was VP-marketing and sales for Boots Pharmaceuticals. He started his career at Baxter International. Fujisawa USA Chairman and CEO Takrashi Aoki was recently appointed as vice chairman of the parent firm, Fujisawa Pharmaceutical. He also will continue to serve on the board of directors of the Japanese parent company.
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