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Novopharm says ranitidine ANDA purity standard is identical to Glaxo patent application.

This article was originally published in The Tan Sheet

Executive Summary

NOVOPHARM SAYS RANITIDINE FORM 1 PURITY STANDARD IN ANDA IS SAME AS GLAXO's standard used in patenting Form 2 Zantac. During arguments in patent litigation against Glaxo Wellcome in Elizabeth City, N.C., Novopharm attorneys claimed that Glaxo had flip-flopped on the purity standards for ranitidine since the two companies' last patent trial in 1993.
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