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Noramco Reactivates Drug Master File for API Methylnaltrexone Bromide

The active ingredient in Relistor, an FDA-approved prescription medication for the treatment of opioid-induced constipation.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Noramco, LLC, a North American producer of controlled substance and specialty bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, has reactivated its previously filed Type II Drug Master File (DMF) to the U.S. FDA for the active pharmaceutical ingredient methylnaltrexone bromide. The DMF number is 026528 and the FDA has acknowledged the DMF is again active.   Methylnaltrexone bromide is the active ingredient in Relistor, an FDA-approved prescription medication for th...

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