Welcome to our dedicated page for Elite Pharmaceuticals news (Ticker: ELTP), a resource for investors and traders seeking the latest updates and insights on Elite Pharmaceuticals stock.
Overview of Elite Pharmaceuticals Inc.
Elite Pharmaceuticals Inc. (ELTP) is a specialty pharmaceutical company renowned for developing, manufacturing, and distributing niche generic products. With a strategic focus on sustained and controlled release oral formulations, the company transforms life cycle management of off-patent drugs into innovative and high barrier-to-entry generic solutions. Utilizing state-of-the-art technology and stringent regulatory standards such as cGMP and DEA requirements, Elite positions its product lines within a competitive landscape while ensuring manufacturing excellence and quality assurance.
Core Business Areas and Product Innovation
At its core, Elite Pharmaceuticals specializes in controlled release drug products that address common challenges in drug delivery, particularly in chronic pain management and central nervous system disorders. The company’s streamlined process encompasses:
- Formulation Innovation: Engineering novel sustained release and immediate-release products to improve therapeutic outcomes.
- ANDA Lifecycle Management: Assisting partner companies in refining and life cycle managing off-patent drug products to extend market viability.
- Pipeline Development: Developing advanced generic formulations, including abuse-resistant opioids and other critical therapeutics, ensuring robust barriers to market entry for competitors.
Manufacturing Excellence and Regulatory Adherence
Elite Pharmaceuticals operates a cGMP and DEA registered facility in Northvale, NJ, underscoring its commitment to quality and compliance. This facility is equipped for research and development, as well as full-scale manufacturing, enabling the company to consistently meet rigorous FDA standards. The company has secured multiple ANDA approvals, reinforcing its capability to navigate complex regulatory environments and deliver reliable generic drug products across multiple therapeutic classes.
Strategic Partnerships and Market Position
The company distinguishes itself through strategic alliances with established pharmaceutical marketing and distribution partners. Such collaborations facilitate expanded market access and efficient product lifecycle management. For instance, partnerships with firms like TAGI Pharma and ECR Pharmaceuticals enhance Elite's portfolio and operational reach, while licensing arrangements support broader product dissemination under the Elite Laboratories label.
Competitive Landscape and Value Proposition
In a highly competitive generic pharmaceuticals sector, Elite Pharmaceuticals maintains its relevance by focusing on high-quality, controlled-release oral dosage forms that are considerably challenging for competitors to replicate. By emphasizing innovation in formulation, regulatory expertise, and strategic market positioning, the company provides an enduring value proposition. Its targeted product strategy, ranging from generic methotrexate sodium tablets to controlled-release opioid formulations for chronic pain, exemplifies deep industry insight and a commitment to addressing unmet therapeutic needs.
Conclusion
Elite Pharmaceuticals Inc. stands as a nuanced and credible entity within the specialty pharmaceuticals community. Its robust R&D capabilities, state-of-the-art manufacturing facility, and strategic collaborations collectively underscore its expertise in developing niche generic products. Whether addressing the complexities of controlled release formulations or achieving regulatory milestones, Elite continues to build a comprehensive portfolio designed to excel in both immediate and long-term market demands.
Elite Pharmaceuticals (OTCQB: ELTP) has achieved a significant operational milestone with the first product shipment from its newly FDA-approved expanded campus in Northvale, New Jersey. The facility at 144 Ludlow Avenue features advanced packaging capabilities, inventory space, and warehouse facilities.
The highlight of the expansion is a state-of-the-art packaging line that can process approximately 120 bottles per minute. This development enables Elite to repurpose existing packaging areas into additional manufacturing suites, substantially boosting production capacity. The expansion is strategically designed to accommodate the company's projected packaging requirements for the next five years.
Elite Pharmaceuticals (OTCQB: ELTP) reported financial results for Q3 FY2025 ended December 31, 2024. The company saw consolidated revenues of $14.4 million, representing an 8% decrease ($1.2 million) compared to the same period last year. Operating profits declined by 69% to $1.1 million, a $2.4 million decrease from the previous year.
The company attributed the performance decline to timing differences during the December holiday period, which resulted in shipment delays into the first week of January 2025. Elite Pharmaceuticals, which specializes in developing, manufacturing, and distributing niche generic products, has scheduled a conference call for February 14, 2025, at 11:30 AM EST to discuss these results and provide business updates.
Elite Pharmaceuticals (OTCQB: ELTP), a specialty pharmaceutical company focused on niche generic products, has scheduled its Q3 FY2025 financial results release for February 13, 2025. The company will host a conference call on February 14, 2025, at 11:30 AM EST to discuss financial and operating results, along with providing a business update.
Stockholders are invited to submit questions prior to the call, with general questions due by February 12, 2025 (5:00 PM EST) and financial questions by February 13, 2025 (7:00 PM EST). The conference call will be accessible via domestic (1-800-346-7359) and international (1-973-528-0008) dial-in numbers using conference number 98840.
Elite Pharmaceuticals (OTCQB: ELTP) has launched its generic version of Vyvanse® (Lisdexamfetamine Disylate) for treating attention deficit hyperactivity disorder (ADHD). The product is available in seven different strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules. The generic drug will be marketed and sold under the Elite Laboratories label. According to IQVIA data, the original drug recorded annual sales of approximately $4.3 billion for the twelve months ending October 2024.
Elite Pharmaceuticals (OTCQB: ELTP) has launched its generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets, USP CII) in four different strengths: 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg, and 10mg/325mg. The medication is indicated for managing severe pain requiring opioid analgesics when alternative treatments are inadequate. According to IQVIA, the annual sales for this product reached approximately $300 million for the twelve months ending September 2024.
Elite Pharmaceuticals (OTCQB: ELTP) has received FDA approval for its generic version of Vyvanse (Lisdexamfetamine Dimesylate) capsules in seven different strengths ranging from 10 mg to 70 mg. The medication is designed to treat Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA data, the combined brand and generic market for this product recorded annual sales of $4.3 billion for the twelve months ending September 2024.
Elite Pharmaceuticals (OTCQB: ELTP) reported strong financial results for Q2 FY2025 ended September 30, 2024. Consolidated revenues reached $18.9 million, marking a significant 33% increase ($4.7 million) compared to the same period last year. Operating profits rose to $3.5 million, showing an impressive 84% growth ($1.6 million) year-over-year. The improved performance was primarily driven by higher sales in Elite's label product line during the quarter.
Elite Pharmaceuticals (OTCQB: ELTP), a specialty pharmaceutical company, announced it will release its second quarter financial results for fiscal year 2025 on November 14, 2024. A live conference call to discuss these results and provide a business update is scheduled for November 15, 2024, at 11:30 AM EST. Stockholders can submit questions to be addressed during the call, with general queries due by November 13 and financial questions by November 14. The call will be accessible via dial-in numbers and an audio replay will be available on the company's website.
Elite Pharmaceuticals (OTCQB: ELTP) has received approval from the Israeli Ministry of Health for its generic version of Adderall®. The product, an immediate-release mixed salt of amphetamine, will be available in 10 mg, 20 mg, and 30 mg tablets. Elite will supply the product to Dexcel Pharma, its exclusive distributor for the Israeli market.
The generic Adderall® is indicated for treating Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Under the agreement, Elite will manufacture and package the product under Dexcel's label, while Dexcel will handle sales, marketing, and distribution. Dexcel will pay an agreed transfer price and share profits under certain conditions. The product is jointly owned by Elite and Mikah Pharma .
The first shipment timeline depends on licensee orders, DEA quotas, and manufacturing processes, which could take months to complete.
Elite Pharmaceuticals (OTCQB: ELTP) has announced the commercial launch of its generic version of Tylenol with Codeine (acetaminophen and codeine phosphate) tablets. The product is available in three strengths: 300mg/15mg, 300mg/30mg, and 300mg/60mg. These tablets are indicated for managing mild to moderate pain where opioid treatment is appropriate and alternative treatments are inadequate.
The product is marketed and sold under the Elite Laboratories, Inc. label. According to IQVIA data, the total U.S. sales of acetaminophen and codeine in these strengths were approximately $47 million for the 12 months ended May 2024. This launch represents Elite's entry into a significant market segment for pain management medications.
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