Wilmington-based Noramco, LLC has submitted a Type II Drug Master File to the U.S. Food and Drug Administration (FDA) for the active ingredient lisdexamfetamine dimesylate (Lisdex/LDX).
Noramco is now advancing into commercial scale production in anticipation of growing demand from generic customers as the patent for the branded version of Lisdex reaches its 2023 expiration dae.
Lisdex is the ingredient for Vyvanse, a branded pharmaceutical product for the treatment of attention deficit hyperactivity disorder (ADHD), with 2019 annual sales surpassing $2.5 billion.
“As an established leader in the provision of controlled substance bulk APIs, advancing our ADHD API portfolio is one of our top priorities. This new DMF adds to our market-leading position in this category, allowing us to offer customers APIs for top-selling ADHD products including methylphenidate,” said L. Lee Karras, Noramco Group CEO.
The company has the capability to manufacture up to 20 metric tons of Lisdex at its Wilmington, FDA-inspected manufacturing site.
Noramco, headquartered in Wilmington, Delaware, is a leading North American producer of controlled substances bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry. The company offers cannabinoids and clinical CDMO API services through its affiliate Purisys LLC, as well as many commercial APIs for use in abuse prevention, attention deficit hyperactivity disorders, pain management, and addiction management.
Established in 1979, Noramco maintains production and R&D facilities in Delaware and Georgia and accesses agriculturally produced starting materials from Tasmania through an affiliate. For more information, log on to www.noramco.com.
