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Executive Summary

SUPERPHARM EX-EXECS AZEEM AND MANNAN SET FOR JURY TRIAL JAN. 27 in Baltimore federal court. Former Superpharm VP-Technical Services Mohammed Azeem and former R&D department manager Muhammed Mannan each were charged in May with one count of conspiracy to make false statements about ANDAs and two counts of filing false statements for two ANDAs. Azeem entered a not guilty plea on June 7; Mannan pled not guilty on June 10. Each man faces up to five years in prison and a $10,000 fine. The case is being handled by Maryland Assistant U.S. Attorney Ray Bonner and will be heard by Judge John Hargrove. Azeem and Mannan are charged with conspiracy by the Maryland U.S. Attorney's office for having "falsified batch records, testing summaries, inventory records and laboratory reports to cover [Superpharm's] actual procedures and results" ("The Pink Sheet" May 6, T&G-3). A press release on the indictment also charges that Azeem directed Superpharm employees, including Mannan, "to subvert the FDA review process by creating false data for inclusion in Superpharm's [ANDA] applications and records rather than adhering to the required research and development experimentation process." The conspiracy charges relate to the ANDAs of seven products formerly marketed by the company: hydralizine HCl/hydrochlorothiazide 50/50 mg capsules; ibuprofen 400 mg tablets; diazepam 2, 5 and 10 mg tabs; Iorazepam 0.5 mg tabs; and propranolol HCl 10 mg tabs. The two former Superpharm employees are also charged with having "misrepresented the dissolution test results of one lot" of hydralizine/hydrochlorothiazide "as test results for another lot." They are also charged with having misrepresented to FDA "the batch size actually produced, the date the lot was produced, the lot number of the active ingredient actually used and the color" of the company's propranolol tabs. All of Superpharm's ANDAs eventually were withdrawn; the company's remaining assets are under the control of the Orlove family, the former owners of generic drug distributor Goldline. Ivax completed the purchase of Goldline in December ("The Pink Sheet" Jan. 6, T&G-5). Azeem left Superpharm in 1986 and went on to work as a consultant to American Therapeutics, Inc. Shortly before the charges related to Azeem's work at Superpharm were brought against him in May, Azeem completed serving a six-month sentence for offering illegal cash gratuities to a number of FDA employees in connection with his work for ATI ("The Pink Sheet" June 11, 1990, T&G-3). Mannan's whereabouts were unknown for some time after the charges against him were issued. According to the Baltimore federal court, he was apprehended in Seattle in early June. He was returned to Maryland to enter a plea of not guilty.

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