Noramco Announces Submission of Drug Master File for Lisdexamfetamine Dimesylate ─ Active Pharmaceutical Ingredient

Sadye Matula

Dec 3 2021 Noramco, LLC, a primary North American producer of managed compound bulk Energetic Pharmaceutical Ingredients (APIs) for the pharmaceutical field, today announced it has submitted a Sort II Drug Grasp File (DMF) to the U.S. Foodstuff and Drug Administration (Food and drug administration) for the energetic pharmaceutical component […]

Noramco, LLC, a primary North American producer of managed compound bulk Energetic Pharmaceutical Ingredients (APIs) for the pharmaceutical field, today announced it has submitted a Sort II Drug Grasp File (DMF) to the U.S. Foodstuff and Drug Administration (Food and drug administration) for the energetic pharmaceutical component lisdexamfetamine dimesylate (Lisdex/LDX). The DMF variety is 035645. The Food and drug administration acknowledged receipt of the submission on November 23, 2021. Noramco has paid the DMF fee necessary less than GDUFA and has done GMP validation batches. Noramco is now advancing into business scale manufacturing in anticipation of increasing desire from generic consumers as the patent for the branded version of Lisdex nears expiry in 2023.

Lisdex is the API for Vyvanse®, the leading branded pharmaceutical merchandise for the treatment of awareness deficit hyperactivity condition (ADHD), with FY 2019 once-a-year gross sales surpassing $2.5 billion. Patient need for the generic variation is expected to be strong after the patent expires.

“As an proven leader in the provision of controlled compound bulk APIs, advancing our ADHD API portfolio is 1 of our best priorities. This new DMF adds to our market-leading situation in this group, allowing us to offer you customers APIs for prime-offering ADHD goods which include methylphenidate,” said L. Lee Karras, Noramco Team Main Govt Officer. “We are effectively positioned to supply substantial quantities of Lisdex to generics shoppers, and buyers can ask for samples now to qualify Lisdex from Noramco to use in their Abbreviated New Drug Application (ANDA) submissions for Vyvanse® generics. We are very pleased of our lengthy-standing standing for top quality and our prospects can progress with their submissions secure in the know-how they will not face issues with Noramco’s DMF filings.”

The corporation has the capacity to manufacture up to 20 metric tons of Lisdex at its Wilmington, DE Fda-inspected GMP manufacturing internet site.

About Noramco, LLC

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Noramco, headquartered in Wilmington, Delaware, is a primary North American producer of managed substances bulk Energetic Pharmaceutical Substances (APIs) for the pharmaceutical industry. The firm gives cannabinoids and clinical CDMO API providers by means of its affiliate Purisys LLC, as well as many industrial APIs for use in abuse prevention, consideration deficit hyperactivity issues, pain administration, and dependancy administration. Set up in 1979, Noramco maintains creation and R&D facilities in Delaware and Ga (United states), and accesses agriculturally generated starting resources from Tasmania through an affiliate, Extractas Biosciences (fka Tasmanian Alkaloids). For extra facts, please pay a visit to www.noramco.com.

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