Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products, to improve off-patent drug products, and developing generic versions of controlled release drug products with high barriers to entry. Elite has four ANDA products partnered with TAGI Pharma; one ANDA has launched, two ANDAs are in the process of a manufacturing site transfer and an additional ANDA is currently under review by the FDA.  Elite also manufactures Lodrane D® and receives royalties for Lodrane D®, an allergy product partnered with ECR Pharmaceuticals (“ECR”), a wholly owned subsidiary of Hi-Tech Pharmacal (“Hi-Tech”).  Elite’s lead pipeline products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are novel 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 has partnered with Mikah Pharma to develop a new product and with Hi-Tech Pharmacal to develop an intermediate for a generic product.  Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.

Biotechnology

Pharmaceutical

Elite Pharmaceuticals, Inc.

Nasrat Hakim

Kirko Kirkov

Doug Plassche

Tytiana James

The Quality Control Team at Elite Pharmaceuticals, Inc. ensures that all oral sustained and controlled release products meet stringent quality standards and regulatory requirements. This multi-disciplinary team, composed of roles such as Quality Assurance and Compliance Associate, Quality Control & Raw Materials Chemist, and QC Laboratory Coordinators, conducts rigorous testing, monitoring, and validation processes. They are pivotal in maintaining product integrity from raw material inspection through to final product release, thereby supporting the company's commitment to high barriers to entry and consistent efficacy in off-patent and novel drug formulations.

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