Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma, Dr. Reddy’s Laboratories and Valeant Pharmaceuticals International.
Elite currently has nine commercial products currently being sold, four products under review pending approval by the FDA, additional approved products pending manufacturing site transfer and the NDA for SquestOx™, for which it received the CRL from the FDA.
Elite’s lead pipeline products include abuse-deterrent opioids utilizing the Company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse.
Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.).
Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.