Followers | 33 |
Posts | 12837 |
Boards Moderated | 0 |
Alias Born | 08/29/2012 |
![](https://investorshub.advfn.com/uicon/358504.png?cb=1619682600)
Saturday, January 01, 2022 4:24:36 AM
Dec 3 2021
Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for the active pharmaceutical ingredient lisdexamfetamine dimesylate (Lisdex/LDX). The DMF number is 035645. The FDA acknowledged receipt of the submission on November 23, 2021. Noramco has paid the DMF fee required under GDUFA and has completed GMP validation batches. 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 nears expiry in 2023.
Lisdex is the API for Vyvanse®, the leading branded pharmaceutical product for the treatment of attention deficit hyperactivity disorder (ADHD), with FY 2019 annual sales surpassing $2.5 billion. Patient demand for the generic version is expected to be strong after the patent expires.
“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 Chief Executive Officer. “We are well positioned to supply significant quantities of Lisdex to generics customers, and customers can request samples now to qualify Lisdex from Noramco to use in their Abbreviated New Drug Application (ANDA) submissions for Vyvanse® generics. We are proud of our long-standing reputation for quality and our customers can proceed with their submissions secure in the knowledge they will not encounter issues with Noramco’s DMF filings.”
The company has the capability to manufacture up to 20 metric tons of Lisdex at its Wilmington, DE FDA-inspected GMP manufacturing site.
MAKE ELITE GREAT AGAIN!
Recent ELTP News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 08:07:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/20/2024 08:30:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 09:55:26 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/29/2023 07:21:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/26/2023 09:20:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/12/2023 09:20:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/28/2023 12:05:38 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/27/2023 11:58:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/27/2023 11:50:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration with ZenaDrone • InvestorsHub NewsWire • 11/16/2023 12:32:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/25/2023 08:15:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/07/2023 08:05:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2023 09:30:05 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 07/31/2023 08:20:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/17/2023 08:15:16 PM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM