Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, manufacturing, and marketing generic and branded controlled-release drugs.

# Company Summary: Elite Pharmaceuticals, Inc.

## Overview
- **Industry:** Specialty pharmaceutical company
- **Location:** Northvale, New Jersey
- **Website:** www.elitepharma.com

## Business Focus
- Development and manufacture of **oral, controlled-release products**
- Manufacturing of **generic pharmaceuticals**
- Focus on creating **generic versions of controlled-release drugs** with high barriers to entry
- Operates manufacturing, warehouse, laboratory, and office spaces at 135, 144, and 165 Ludlow Avenue in Northvale, NJ
- Manufacturing facility complies with **Current Good Manufacturing Practice (cGMP)** and is DEA registered for research, development, and production

## Core Strategies
- Produce generic drugs with **approved Abbreviated New Drug Applications (ANDAs)**
- Develop new generic drug products and pipeline candidates, including co-developed products and licensed products
- Exploit product candidates via **sales, licensing, or royalties**
- Expand product portfolio with new product development under own label and licensing agreements
- Engage in collaborations, licensing, joint ventures, and co-development projects with other pharmaceutical companies

## Commercial Products (as of 2025)
- Own, license, manufacture, sell, distribute, or receive royalties from several drugs:
  - **Weight Loss & Obesity:** Phentermine HCl (Adipex-P®), Phendimetrazine Tartrate (Bontril®)
  - **Pain Management:** Naltrexone HCl (Revia®), Acetaminophen & Codeine phosphate, Acetaminophen & Hydrocodone (Norco®)
  - **Cardiovascular:** Isradipine capsules
  - **Psychiatric:** Trimipramine maleate capsules, Loxapine succinate capsules
  - **Anti-epileptic:** Vigabatrin Powder (sold to Pyros Pharmaceuticals in 2022)
  - **Immunosuppressant:** Methotrexate Sodium Tablets (approved August 2024)
  - **Multiple opioids and CNS stimulants:** Amphetamine IR and ER tablets, Lisdexamfetamine (Vyvanse®), Oxycodone/Acetaminophen (Percocet®), among others
  - **Others:** Dantrolene capsules, Loxapine capsules, Methotrexate, Vigabatrin Powder (sold), and several recently launched products like Oxycodone/Acetaminophen, Lisdexamfetamine, and more

## Products Under Development
- **Abuse-deterrent opioid candidates,** including SequestOx™ (marketed as paused development)
- Several generic drugs in filings:
  - Dopamine agonist, opiate analgesic
  - Doxycycline Hyclate Tablets (approved 2022)
  - Methadone Hydrochloride Tablets
- Several other candidates under evaluation or not yet commercialized

## Regulatory and Legal
- Extensive FDA, DEA, and international regulation compliance
- Patented formulations (expiring in 2030), trademarks (e.g., SequestOx™)
- Involved in ongoing research, clinical trials, and NDA/ANDA filings
- Focus on generic and branded products, including some with advanced drug delivery and abuse-deterrent technologies

## Financials (as of March 31, 2025)
- **Number of Employees:** 68 full-time employees
- **Revenue:** $84.0 million (for year ended March 31, 2025)
- **Net Income (Loss):** -$4.3 million
- **Market Capitalization (based on most recent stock price):** Approximately **$323.3 million** (as of June 2025)
- **Outstanding Shares:** 1,068,463,108 shares of common stock (as of June 27, 2025)

## Additional Details
- The company’s operations are primarily focused on **generic pharmaceutical products**.
- Revenue heavily concentrated on a small number of products (~90% from top four products).
- Significant dependence on **third-party suppliers and distributors**.
- Company continuously evaluates product portfolio, including transferring or discontinuing products.
- **Cybersecurity** protocols include best practices aligned with NIST standards, monitoring, threat management, and third-party cybersecurity partnerships.

Elite Pharmaceuticals is a specialty pharmaceutical company that develops and manufactures controlled-release and generic drug products while focusing on research and innovation in drug development.

# Company Overview: Elite Pharmaceuticals, Inc.

## General Information
- **Incorporation**: Elite Pharmaceuticals, Inc. was incorporated on October 1, 1997, in Delaware and later reincorporated in Nevada on January 5, 2012. 
- **Subsidiary**: Elite Laboratories, Inc. was founded on August 23, 1990, also in Delaware.
- **Website**: [www.elitepharma.com](http://www.elitepharma.com)

## Core Business Activities
Elite Pharmaceuticals is a specialty pharmaceutical company focused on:
- **Development**: Primarily engaged in developing and manufacturing oral, controlled-release products.
- **Generic Pharmaceuticals**: Manufacturing generic pharmaceuticals with a strategy to create generic versions of controlled-release drug products that have high barriers to entry.
- **Research & Development**: The company maintains a diverse product portfolio by evaluating opportunities for both branded and generic drug products.

## Facility
- **Location**: The Northvale Facility located at 135, 144, and 165 Ludlow Avenue, Northvale, NJ.
- **Compliance**: The facility operates under Current Good Manufacturing Practice (cGMP) and is registered with the Drug Enforcement Agency (DEA) for research, development, and manufacturing.

## Market Presence
- **Customers**: Elite Pharmaceuticals has a substantial customer base, with their top six customers accounting for over 80% of revenues for the year ended March 31, 2024.
- **Employees**: As of June 1, 2024, Elite employs **64 full-time employees** engaged in various roles including operations, administration, and research and development.

## Financial Performance
- **Revenue**: For the fiscal year ended March 31, 2024, Elite reported revenues of **$56.6 million**, compared to **$34.2 million** in the prior year.
- **Net Income**: The company achieved a net income of **$20.1 million** for the same period, marking its success in the marketplace after its first profitable year in fiscal year 2021. 

## Product Offerings
Elite Pharmaceuticals has a portfolio of commercialized products, including:
- **Phentermine HCl** tablets (various strengths) – **Bariatric**
- **Phendimetrazine Tartrate** tablets – **Bariatric**
- **Amphetamine IR and ER Tablets** – **Central Nervous System (CNS) Stimulant**
- **Naltrexone HCl** tablets – **Pain Management**
- **Dantrolene Sodium Capsules** – **Muscle Relaxant**
- **Vigabatrin Powder** – **Anti-epileptic** (Launched in January 2024)

## Strategic Goals
The company aims to:
- Continue developing generic and branded pharmaceutical products.
- Expand licensing agreements with other pharmaceutical companies.
- Enhance production capabilities at its DEA-registered facility.

## Research and Development Focus
Elite Pharmaceuticals is actively pursuing innovation in drug development and exploring its proprietary abuse-deterrent technology aimed at opioid products, although the development of its flagship product, **SequestOx™, is currently paused.**

## Summary
Elite Pharmaceuticals plays a significant role in the pharmaceutical industry by providing a range of controlled-release and generic products. The company seeks to maintain its growth trajectory through strategic partnerships, diversification of its product line, and adherence to stringent regulatory standards in a highly competitive market.

ELITE PHARMACEUTICALS INC /NV/

10-K / June 30, 2025

10-K / July 1, 2024

10-K / June 30, 2025

Company Summary: Elite Pharmaceuticals, Inc.

Overview

Business Focus

Core Strategies

Commercial Products (as of 2025)

Products Under Development

Regulatory and Legal

Financials (as of March 31, 2025)

Additional Details