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This article was originally published in The Tan Sheet

Executive Summary

BIOPHARMACEUTICS BEGINS SHIPMENT OF FIVE OTC PRODUCTS NOV. 22 after an FDA inspection on Nov. 19 found the company's Bellport, N.Y. facility to be in compliance with current good manufacturing practices. The five products are: 80 mg chewable acetaminophen tablets in fruit and grape flavor, 500 mg acetaminophen tablets and caplets and 50 mg dimenhydrinate tablets. FDA approved the process validation for the five items in October but said it needed to verify by inspection that the products were in compliance with GMPs ("The Tan Sheet" Oct. 11, In Brief). The Nov. 19 inspection also paves the way for Biopharmaceutics to begin shipping other OTC as well as prescription drugs. Biopharmaceutics expects to submit 15 additional OTC and prescription products to FDA for clearance in 1994. The 20 products constituted 90% of Biopharmaceutics' sales volume of manufactured goods before FDA obtained a temporary restraining order in November 1991 that prohibited the firm from manufacturing any generics because of GMP violations at the facility. The temporary restraining order was followed by a consent decree in late November 1991 under which Biopharmaceutics was required to have an independent consultant verify GMP compliance at the Bellport facility. In July, Biopharmaceutics agreed to pay $ 350,000 to settle a Justice Department investigation into submission of false R&D information on ANDAs for Rx clindamycin 150 mg capsules, carisoprodol with aspirin and chlorzoxazone 500 mg tablets. Former company VP Abu Quamruzzaman was sentenced Oct. 14 to nine months in prison after pleading guilty in July to submitting the false ANDA information for clindamycin 150 mg capsules.

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