WILMINGTON, Del.– Noramco, LLC, a leading North American producer of controlled substance and specialty bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has reactivated its previously filed Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (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 indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic pain. OIC is a common adverse effect experienced by many patients on opioid therapy, and it can result in considerable impairment in their quality of life. Methylnaltrexone bromide is a significant advancement, providing relief for these patients who need to manage chronic pain with opioids.
At present, there are only two U.S. API manufacturers of methylnaltrexone bromide and no generic equivalents to the branded oral solid or injectable versions of the finished product on the market due to patent exclusivity. Additionally, the synthesis is complex, requiring a difficult-to-source key agricultural starting material and involving numerous synthetic steps. With the injectable version of the product coming off patent in 2024, and the oral solid product after, Noramco will be able to commercially supply over one metric ton per year of the product at its FDA-inspected site in Wilmington, Delaware, located in close proximity to key finished dose producers in the northeast U.S.
Not only is Noramco an experienced large-scale commercial producer of the precursor compound naltrexone, but the company has also commercially supplied methylnaltrexone bromide through a sister facility in Europe dating back to 2012. The company will leverage this know-how in its domestic production of methylnaltrexone bromide. Additionally, Noramco will be the only domestic supplier with a fully integrated supply chain that includes the key alkaloid starting material.
“Production of methylnaltrexone bromide leverages several of Noramco’s most distinctive attributes, including our integrated ‘Field-to-Formulation’ capabilities,” noted L. Lee Karras, Noramco Group Chief Executive Officer. “We have decades of experience with the exceedingly complex chemistry required to produce this API and our vertical integration will ensure exceptional security of supply for our customers seeking a source of this material for development and eventual commercialization.”