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EMA Clears Toansa Site To Rekindle Ranbaxy’s Hopes But U.S. FDA Stays Firm

This article was originally published in The Pink Sheet Daily

Executive Summary

A sharp divergence in global regulatory standards surfaced with the European Medicines Agency showing the green light to Ranbaxy’s Toansa manufacturing site, while the U.S. FDA stays firm on its findings of shortcomings in the manufacturing practices. For now, the EMA brings relief to Ranbaxy, but for how long is the question. A subpoena issued in April by the United States Attorney for the District of New Jersey related to certain documents at Toansa may keep the mood subdued.

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