Elite Pharmaceuticals, Inc. (ELTP)
For informational purposes only. Not financial advice. Analysis by Sedat Aydin, Founder & Editor-in-Chief | AI-powered analysis. Data sourced from SEC filings and institutional-grade financial providers. Editorially reviewed. Not financial advice.
Elite Pharmaceuticals, Inc. (ELTP) with AI Score 53/100 (Hold). Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and manufacturing oral, controlled-release products and generic pharmaceuticals. Market cap: 0, Sector: Healthcare.
Last analyzed: Mar 16, 2026Elite Pharmaceuticals, Inc. (ELTP) Healthcare & Pipeline Overview
Elite Pharmaceuticals, Inc., a specialty pharmaceutical company, develops, manufactures, and markets oral, controlled-release, and generic pharmaceuticals. Operating through ANDA and NDA segments, the company offers products for pain management, bariatrics, and cardiovascular diseases. Its focus on abuse-deterrent opioid formulations and contract manufacturing positions it within the competitive generic drug market.
Investment Thesis
Elite Pharmaceuticals, Inc. presents a compelling investment thesis based on its established position in the generic pharmaceuticals market and its strategic focus on developing abuse-deterrent opioid products. With a P/E ratio of 9.65 and a profit margin of 31.0%, the company demonstrates financial stability and profitability. Key value drivers include the continued demand for its generic products, such as Phentermine and Phendimetrazine, and the potential for revenue growth from its pipeline of abuse-deterrent formulations. Growth catalysts include successful clinical trials and regulatory approvals for its abuse-deterrent opioid products, as well as expansion of its contract manufacturing business. Potential risks include competition from other generic drug manufacturers, regulatory challenges, and the inherent uncertainties associated with pharmaceutical product development. Investors should closely monitor the company's progress in advancing its pipeline and securing new contract manufacturing agreements.
Based on FMP financials and quantitative analysis
Key Highlights
- Market Cap of $0.42B reflects the company's current valuation in the specialty pharmaceutical sector.
- P/E Ratio of 9.65 indicates the stock may be undervalued compared to its earnings.
- Profit Margin of 31.0% demonstrates strong profitability and efficient operations.
- Gross Margin of 51.1% highlights the company's ability to maintain healthy margins on its products.
- Beta of 0.36 suggests the stock is less volatile than the overall market.
Competitors & Peers
Strengths
- Established manufacturing capabilities for controlled-release and abuse-deterrent formulations.
- Portfolio of approved generic and branded products.
- Contract manufacturing agreements with third parties.
- Expertise in navigating the regulatory approval process.
Weaknesses
- Limited financial resources compared to larger pharmaceutical companies.
- Dependence on a small number of key products.
- Exposure to pricing pressures in the generic drug market.
- Reliance on contract manufacturing agreements for a significant portion of revenue.
Catalysts
- Upcoming: Potential FDA approval and launch of new abuse-deterrent opioid products.
- Ongoing: Expansion of contract manufacturing agreements with third parties.
- Ongoing: Continued revenue growth from existing generic and branded products.
Risks
- Potential: Competition from other generic drug manufacturers.
- Potential: Regulatory challenges and delays in product approvals.
- Potential: Pricing pressures and reimbursement changes.
- Potential: Product liability claims and litigation.
- Ongoing: Dependence on a small number of key products.
Growth Opportunities
- Expansion of Abuse-Deterrent Opioid Pipeline: Elite Pharmaceuticals is actively developing a range of abuse-deterrent opioid products. The market for these products is driven by the ongoing opioid crisis and the need for safer pain management options. Successful development and commercialization of these products could significantly increase revenue and market share. The global abuse-deterrent opioid market is projected to reach $3.9 billion by 2027, presenting a substantial growth opportunity for Elite. Timeline: Ongoing, with potential product launches within the next 3-5 years.
- Increased Contract Manufacturing Agreements: Elite Pharmaceuticals manufactures controlled-release products on a contract basis for third parties. Expanding this business segment can provide a stable revenue stream and leverage the company's manufacturing capabilities. The contract manufacturing market for pharmaceuticals is expected to grow as companies increasingly outsource production to specialized manufacturers. This represents a significant growth opportunity for Elite. Timeline: Ongoing, with potential for new agreements within the next 1-2 years.
- Geographic Expansion: Elite Pharmaceuticals currently focuses on the US market. Expanding into international markets, particularly emerging economies with growing healthcare needs, could drive revenue growth. This would require navigating regulatory hurdles and establishing distribution networks, but the potential rewards are significant. The global pharmaceutical market is expected to reach $1.57 trillion by 2028, offering ample opportunities for geographic expansion. Timeline: Medium-term, with potential entry into new markets within the next 3-5 years.
- Development of Novel Drug Delivery Systems: Investing in the development of novel drug delivery systems, such as extended-release or targeted delivery technologies, could provide a competitive advantage and create new revenue streams. These technologies can improve drug efficacy, reduce side effects, and enhance patient compliance. The market for advanced drug delivery systems is growing rapidly, driven by the demand for more effective and convenient treatments. Timeline: Long-term, with potential product launches within the next 5-7 years.
- Strategic Acquisitions: Elite Pharmaceuticals could pursue strategic acquisitions of complementary businesses or product lines to expand its portfolio and market reach. This could involve acquiring other generic drug manufacturers, specialty pharmaceutical companies, or drug delivery technology firms. Strategic acquisitions can accelerate growth and create synergies. The pharmaceutical industry is characterized by ongoing consolidation, presenting opportunities for strategic acquisitions. Timeline: Opportunistic, depending on market conditions and available targets.
Opportunities
- Expansion of abuse-deterrent opioid pipeline.
- Increased contract manufacturing agreements.
- Geographic expansion into international markets.
- Development of novel drug delivery systems.
Threats
- Competition from other generic drug manufacturers.
- Regulatory challenges and delays in product approvals.
- Pricing pressures and reimbursement changes.
- Product liability claims and litigation.
Competitive Advantages
- Specialized Manufacturing Capabilities: Elite possesses expertise in manufacturing controlled-release and abuse-deterrent formulations, creating a barrier to entry.
- Established Product Portfolio: The company has a portfolio of approved generic and branded products, providing a stable revenue base.
- Regulatory Expertise: Navigating the regulatory approval process for pharmaceuticals requires specialized knowledge and experience, which Elite possesses.
- Contract Manufacturing Relationships: Long-standing relationships with contract manufacturing partners provide a reliable source of revenue and diversification.
About ELTP
Elite Pharmaceuticals, Inc., incorporated in 1997 and headquartered in Northvale, New Jersey, is a specialty pharmaceutical company engaged in the development, manufacture, and commercialization of oral, controlled-release products, and generic pharmaceuticals. The company operates through two segments: Abbreviated New Drug Applications (ANDA) for Generic Products and New Drug Applications (NDA) for Branded Products. Elite Pharma owns, licenses, and contract manufactures various generic and oral dose pharmaceuticals. Key products include Phentermine HCl tablets (Adipex-P brand) and Phendimetrazine Tartrate tablets (Bontril brand) for bariatrics, Naltrexone HCl tablets (Revia brand) for pain treatment, and Isradipine capsules for cardiovascular diseases. Elite also provides Oxycodone HCl immediate-release tablets (Roxycodone brand), Trimipramine Maleate immediate-release capsules (Surmontil brand), and Dextroamphetamine/Amphetamine tablets (Adderall brand). Additionally, Elite manufactures controlled-release products on a contract basis for third parties, focusing on pain, allergy, bariatric, and infection treatments. The company is actively developing abuse-deterrent opioid products, addressing a critical need in pain management. This diversified approach, combining generic pharmaceuticals with branded products and contract manufacturing, positions Elite Pharma within the competitive pharmaceutical landscape.
What They Do
- Develops and manufactures oral, controlled-release pharmaceuticals.
- Produces generic pharmaceuticals through Abbreviated New Drug Applications (ANDA).
- Develops branded products through New Drug Applications (NDA).
- Manufactures products for pain management, bariatrics, and cardiovascular diseases.
- Offers immediate-release and controlled-release formulations.
- Contract manufactures products for third parties.
- Develops abuse-deterrent opioid products.
Business Model
- Develops and manufactures generic pharmaceuticals for various therapeutic areas.
- Generates revenue through the sale of its branded and generic products.
- Provides contract manufacturing services to other pharmaceutical companies.
- Focuses on developing and commercializing abuse-deterrent opioid formulations.
Industry Context
Elite Pharmaceuticals operates within the specialty and generic pharmaceutical industry, a sector characterized by intense competition and regulatory scrutiny. The market is driven by the increasing demand for affordable medications and the expiration of patents on branded drugs. Companies like Elite focus on developing and manufacturing generic versions of established drugs, as well as innovating in areas such as abuse-deterrent formulations. The industry faces challenges including pricing pressures, regulatory hurdles, and the need for continuous innovation to maintain competitiveness. The global generic drug market is projected to reach $459.07 billion by 2028, growing at a CAGR of 6.2% from 2021.
Key Customers
- Pharmacies and retail drug stores.
- Hospitals and healthcare providers.
- Wholesale distributors of pharmaceuticals.
- Other pharmaceutical companies through contract manufacturing agreements.
Financials
Chart & Info
Elite Pharmaceuticals, Inc. (ELTP) stock price: Price data unavailable
Latest News
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Stocks That Hit 52-Week Highs On Tuesday
· Mar 24, 2020
Analyst Consensus
Consensus Rating
Aggregated Buy/Hold/Sell recommendations from Benzinga, Yahoo Finance, and Finnhub for ELTP.
Price Targets
Wall Street price target analysis for ELTP.
MoonshotScore
What does this score mean?
The MoonshotScore rates ELTP's growth potential on a scale of 0-100 across multiple factors including innovation, market disruption, financial health, and momentum.
Leadership: Nasrat Hakim
CEO
Nasrat Hakim serves as the CEO of Elite Pharmaceuticals, Inc. His background includes extensive experience in the pharmaceutical industry, with a focus on generic and specialty drug development and manufacturing. He has held various leadership positions in pharmaceutical companies, overseeing operations, research and development, and commercialization efforts. Hakim's expertise spans regulatory affairs, product development, and strategic planning within the pharmaceutical sector. His leadership is focused on driving innovation and growth at Elite Pharmaceuticals.
Track Record: Under Nasrat Hakim's leadership, Elite Pharmaceuticals has focused on expanding its portfolio of generic and branded products, particularly in the area of abuse-deterrent opioid formulations. He has overseen the company's efforts to secure regulatory approvals for new products and expand its contract manufacturing business. Hakim has also emphasized operational efficiency and cost management to improve profitability. His strategic decisions have aimed to position Elite Pharmaceuticals for long-term growth and success in the competitive pharmaceutical market.
ELTP OTC Market Information
The OTC Other tier represents the lowest tier of the OTC market, indicating that Elite Pharmaceuticals may not meet the minimum financial or disclosure requirements for higher tiers like OTCQB or OTCQX. Companies in this tier may have limited financial reporting, making it more difficult for investors to assess their financial health and operational performance. Investing in companies on the OTC Other tier carries higher risks due to the lack of regulatory oversight and transparency compared to companies listed on major exchanges like the NYSE or NASDAQ. Investors should exercise caution and conduct thorough due diligence before investing in OTC Other stocks.
- OTC Tier: OTC Other
- Disclosure Status: Unknown
- Limited regulatory oversight and disclosure requirements.
- Lower trading volume and liquidity compared to major exchanges.
- Potential for price manipulation and fraud.
- Greater risk of financial distress or bankruptcy.
- Limited access to company information and management.
- Verify the company's financial statements and SEC filings (if any).
- Research the company's management team and their track record.
- Assess the company's business model and competitive landscape.
- Evaluate the company's OTC Markets disclosure tier and compliance status.
- Check for any regulatory actions or legal proceedings against the company.
- Consult with a financial advisor before investing.
- Understand the risks associated with investing in OTC stocks.
- The company has been in operation since 1997.
- Elite Pharmaceuticals has a portfolio of approved generic and branded products.
- The company has contract manufacturing agreements with third parties.
- They have a CEO with experience in the pharmaceutical industry.
Elite Pharmaceuticals, Inc. Stock: Key Questions Answered
What does Elite Pharmaceuticals, Inc. do?
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and markets a range of generic and branded pharmaceutical products. The company focuses on oral, controlled-release medications, including treatments for pain management, bariatrics, and cardiovascular diseases. Elite operates through two segments: Abbreviated New Drug Applications (ANDA) for Generic Products and New Drug Applications (NDA) for Branded Products. Additionally, Elite engages in contract manufacturing for third parties, leveraging its manufacturing capabilities and regulatory expertise.
What do analysts say about ELTP stock?
AI analysis is currently pending for ELTP. Without current analyst ratings, it is important to evaluate Elite Pharmaceuticals based on its financial performance, product pipeline, and market position. Key metrics to consider include revenue growth, profit margins, and progress in developing abuse-deterrent opioid products. Investors should also assess the company's competitive landscape and regulatory environment. This information will allow for a neutral assessment of the stock's potential.
What are the main risks for ELTP?
Elite Pharmaceuticals faces several risks common to the pharmaceutical industry, including competition from other generic drug manufacturers, regulatory challenges and delays in product approvals, and pricing pressures. The company's dependence on a limited number of key products also poses a risk, as does the potential for product liability claims and litigation. Additionally, Elite's reliance on contract manufacturing agreements for a portion of its revenue exposes it to the risk of losing these agreements. Investors should carefully consider these risks before investing in ELTP.
What are the key factors to evaluate for ELTP?
Elite Pharmaceuticals, Inc. (ELTP) currently holds an AI score of 53/100, indicating moderate score. Key strength: Established manufacturing capabilities for controlled-release and abuse-deterrent formulations.. Primary risk to monitor: Potential: Competition from other generic drug manufacturers.. This is not financial advice.
How frequently does ELTP data refresh on this page?
ELTP prices update in real time during U.S. market hours (9:30 AM-4:00 PM ET, weekdays). Fundamentals refresh after quarterly or annual filings. Analyst ratings and AI insights update daily. News is aggregated continuously from financial sources.
What has driven ELTP's recent stock price performance?
Recent price movement in Elite Pharmaceuticals, Inc. (ELTP) can be influenced by earnings results, analyst revisions, sector rotation, and broader market sentiment. Notable catalyst: Established manufacturing capabilities for controlled-release and abuse-deterrent formulations.. Check the News and Technical Analysis tabs for the latest drivers. Past performance does not predict future results.
Should investors consider ELTP overvalued or undervalued right now?
Determining whether Elite Pharmaceuticals, Inc. (ELTP) is overvalued or undervalued requires examining multiple metrics. Compare valuation ratios (P/E, P/S, EV/EBITDA) against sector peers for a comprehensive view.
What research should beginners do before buying ELTP?
Before investing in Elite Pharmaceuticals, Inc. (ELTP), research these four areas: (1) the company's revenue model and competitive position (see Company Overview), (2) financial health through revenue growth, margins, and cash flow (see MoonshotScore), (3) what Wall Street analysts recommend and their price targets (see Analyst tab), and (4) specific risk factors that could impact the stock (see Risk Factors section).
Disclaimer: This content is for informational purposes only and does not constitute investment advice. Always do your own research and consult a financial advisor.
Official Resources
Data provided for informational purposes only.
- Information is based on available sources and may be subject to change.
- AI analysis is pending and may provide additional insights.