Apotex Warning Letter Demands List Of Products That Might Enter U.S.
This article was originally published in The Pink Sheet Daily
FDA already has Bangalore, India plant on an import alert, but the agency may be preparing to go after API from the facility as well after finding persistent use of questionable testing data.
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Pegfilgrastim product, a collaboration with the Indian firm Intas, may have to compete with multiple filgrastim products, along with its reference biologic, Amgen’s Neulasta.
Report says aggressive enforcement in recent years has forced capacity offline, which led to shortages.
The agency sees its personnel compensation and benefits costs decrease for the first time in at least 16 years, while the overall FTE count continues to rise.