FDA strives to tighten API repackaging operations

Some repackagers produce cartons or vials of prescription drugs, ready to be provided to patients; others are intermediaries in delivering active pharmaceutical ingredients (APIs) to manufacturers, compounding pharmacies and others. Several businesses in the latter category have been issued warning […]

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Book Review: Bottle of Lies

There has been a steady drip, drip, drip of reports and regulatory actions for generic drug quality in recent years, with much of the focus on the dramatic growth of the Indian pharmaceutical industry since the turn of the century. […]

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