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.
You may also be interested in...
Indian Investors Turn Cautious On Compliance Concerns
A rising number of enforcement actions by major drug regulators like the U.S. FDA is slowly making investors cautious about the longer term repercussions on earnings of Indian drug makers.
Lee Takes India Compulsory License Fight To Saxagliptin
In a bold move, little known Indian drug firm Lee Pharma has applied for a compulsory license for saxagliptin in India, contending that AstraZeneca sells the diabetes drug at an exorbitant local price and that it is not being made sufficiently available. Lee also says that the originator has not responded to calls to collaborate.
Could Indian heart stent study findings lead to price cuts?
India’s top regulatory agencies are weighing up the findings from a study it had commissioned that looks at the clinical benefits of heart stents, with the possible aim of using the results to back the use of cheaper, locally-produced devices.