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Private label ranitidine

This article was originally published in The Tan Sheet

Executive Summary

Novopharm subsidiary Granutec says it will begin shipping its private label ranitidine 75 mg July 19. Exclusivity for the reference drug, Warner-Lambert's Zantac 75, expires June 19. Novopharm was granted 180-day marketing exclusivity for the generic version by FDA, which would be triggered when the product starts shipping; Apotex challenged FDA's decision on the exclusivity and a hearing on the matter was held in D.C. federal court April 29 ("The Tan Sheet" May 3, p. 6). A decision is still pending. Wilson, N.C.-based Granutec says production of its ranitidine supply is roughly 50% complete





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