Foreign-Source Bulk Ibuprofen Impurity Review Urged By Suppliers
This article was originally published in The Tan Sheet
Incremental consumer exposure to lead or chromium impurities in bulk ibuprofen produced off-shore should be addressed by FDA as it develops a final rule to include the ingredient in the internal analgesics monograph, ingredient suppliers recommend in comments to the agency
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Studies on ibuprofen published in the 1990s confirm the drug's safety at OTC doses, Whitehall-Robins tells FDA in a Sept. 18 submission. The submission contains supplemental information to the company's November 1997 citizen petition requesting the agency include ibuprofen 200 mg in the TFM for Internal Analgesic, Antipyretic & Antirheumatic Drug Products ("The Tan Sheet" Dec. 8, 1997, p. 4).
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