BIOPHARMACEUTICS EXPECTS TO RESUME "PARTIAL" MANUFACTURING IN MARCH

Executive Summary

BIOPHARMACEUTICS EXPECTS TO RESUME "PARTIAL" MANUFACTURING IN MARCH, the Bellport, N.Y.-based generic drug firm said Jan. 13. Biopharmaceutics' operations have been suspended since Nov. 1 when FDA was granted a temporary restraining order against the company for problems with good manufacturing practices ("The Pink Sheet" Nov. 11, T&G-6). FDA "examined the company's premises on Jan. 3 and Jan. 6, 1992 and issued their approval letter on Jan. 10," Biopharmaceutics said in a release. "Biopharm believes it will still take approximately two months before it can recommence partial manufacturing operations and three to four months before it can be back in full manufacturing operations." Biopharm noted that it had entered into an amended consent decree with FDA on Dec. 23. Under an earlier consent decree, the company agreed that the firm's own independent consultant will verify that the company is in full compliance with GMPs ("The Pink Sheet" Nov. 25, p. 7). The company also agreed to provide FDA with a protocol for validating its blending methods and to let the agency inspect facilities to confirm compliance before resuming operations. Biopharmaceutics has maintained that the temporary restraining order was "a direct result" of activities by three former employees, who, while working at the firm, ran a business as an intermediate manufacturer for Biopharmaceutics' raw material supplier. A recent FD-483, issued following a May-June inspection, lists 27 observations, including a notation that finished products "are not representatively sampled at the completion of finishing operations." In the Jan. 13 release, Biopharm noted that "although the company has lost some customers, the majority of its sales and customers remain on line and the company expects to both add new customers and to reacquire some or all of the lost customers during the next six months."