Foreign API Manufacturers Help Ease Methotrexate Shortage

Generic drug manufacturers needed to find additional manufacturers of active pharmaceutical ingredients to fill a gap in production of the vital cancer drug methotrexate.

FDA and drug manufacturers have alleviated a critical shortage of the widely used cancer drug methotrexate by identifying new international sources of active pharmaceutical ingredients, but the potential risks of using foreign API makers just a few years after the tainted heparin scandal cannot be far from anyone’s thoughts.

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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.