News In Brief: Cheap American Drugs Replaced; EMA, FDA Differ on Toansa; Apotex Warned; Cheaper Drug Recalls
This article was originally published in The Gold Sheet
“Cheap China drugs” paradigm turned on its head; EMA disagrees with FDA on Ranbaxy site; Apotex API site fails FDA test; Drug tracing will mean cheaper recalls.
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Persistent data integrity and quality unit failures at two Apotex plants in Bangalore, India, led to wholesale US market withdrawals by the Canadian generic drug manufacturer.
The specialty generic manufacturer has a facility dedicated to producing shortage drugs, a seemingly endless commercial opportunity given the development, regulatory and reimbursement challenges in the sterile injectable space.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.