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 has eight commercial products currently being sold, several additional approved products pending manufacturing site transfer and an additional product under review pending approval by the FDA.
Elite’s lead pipeline products include abuse-deterrent opioids utilizing the Company’s patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse.
Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site transfer, with Akorn, Inc. to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories.
Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.