NORTHVALE, N.J., Feb. 08, 2018 (GLOBE NEWSWIRE) — Elite Pharmaceuticals, Inc. (“Elite” or a “Company”) (OTCBB:ELTP) a specialty curative association building abuse-deterrent opioids and niche general products, now announced that it has filed an Abbreviated New Drug Application (ANDA) with a US Food and Drug Administration (FDA) for a general chronicle of an evident recover CNS stimulant. The ANDA represents a initial filing for a product co-developed with SunGen Pharma, LLC (“SunGen”) underneath a Development and License Agreement (“Agreement”). According to IMS Health information a branded product and a equivalents had sum U.S. sales of some-more than $400 million for a twelve months finale Sep 30, 2017.
Under a terms of a Agreement, a product will be owned jointly by Elite and SunGen. Elite shall have a disdainful right to marketplace and sell a product regulating Elite’s label. Elite will also make and package a product on a cost-plus basis.
“The filing of this ANDA represents a initial of many products being grown underneath this Development and License Agreement with a partner, SunGen,” pronounced Nasrat Hakim, President and CEO of Elite. “In further to a SequestOx™ NDA filing, Elite now has 5 ANDAs tentative with a FDA.”
“The vital partnership with Elite is surpassing awfully well,” pronounced Dr. Jim Huang, Co-CEO of SunGen. “And we are really gratified with a filing of this initial ANDA with some-more to follow.”
About SunGen Pharma LLC
SunGen Pharma, LLC is a secretly hold specialty curative association that develops, agreement manufactures, and sells curative finished products. SunGen specializes in a growth of verbal plain extended recover and formidable injectable products. SunGen has business partnerships with many US-based general curative companies to develop, manufacture, and sell several curative products in a US.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty curative association that is building a tube of exclusive pharmacological abuse halt opioid products as good as niche general products. Elite specializes in verbal postulated and tranquil recover drug products that have high barriers to entry. Elite owns general and OTC products that have been protected to TAGI Pharma, Epic Pharma, Dr. Reddy’s Laboratories and Valeant Pharmaceuticals International. Elite now has 9 blurb products being sold, 5 products filed with a FDA, additional authorized products tentative production site send and a NDA filing for SequestOx™. Elite’s lead tube products embody abuse-deterrent opioids that implement a Company’s law exclusive record and a once-daily opioid. These products embody postulated recover verbal formulations of opioids for a diagnosis of ongoing pain. These formulations are dictated to residence dual vital stipulations of existent verbal opioids: a sustenance of unchanging service of baseline pain levels and anticipation of intensity opioid abuse. Elite also provides agreement production for Ascend Laboratories (a auxiliary of Alkem Laboratories Ltd.). Elite operates a GMP and DEA purebred trickery for research, development, and production located in Northvale, NJ. Learn some-more during www.elitepharma.com.
This press recover contains “forward-looking statements” within a definition of a Private Securities Litigation Reform Act of 1995. Including those associated to a effects, if any, on destiny results, opening or other expectations that might have some association to a theme matter of this press release, readers are cautioned that such forward-looking statements engage risks and uncertainties including, but limitation, Elite’s ability to obtain FDA capitulation of a transfers of a ANDAs or a timing of such capitulation process, delays, uncertainties, inability to obtain required mixture and other factors not underneath a control of Elite, that might means tangible results, opening or achievements of Elite to be materially opposite from a results, opening or other expectations that might be pragmatic by these forward-looking statements. These forward-looking statements might embody statements per a approaching timing of approval, if during all, of SequestOx™ by a FDA, and a actions a FDA need of Elite in sequence to obtain capitulation of a NDA. These forward-looking statements are not guarantees of destiny movement or performance. These risks and other factors, including, but limitation, Elite’s ability to obtain sufficient appropriation underneath a LPC Agreement or from other sources, a timing or formula of tentative and destiny clinical trials, regulatory reviews and approvals by a Food and Drug Administration and other regulatory authorities and egghead skill protections and defenses, are discussed in Elite’s filings with a Securities and Exchange Commission, including a reports on forms 10-K, 10-Q and 8-K. Elite is underneath no requirement to refurbish or change a forward-looking statements, either as a outcome of new information, destiny events or otherwise.
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations