Elite Pharmaceuticals, Inc. (OTCMKTS: ELTP) is a specialty pharmaceutical company that develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to Lannett Company, Prasco, LLC, Epic Pharma, LLC, and TAGI Pharma. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.  

Located in Northvale, New Jersey, Elite operates a 55,000 square foot campus under Current Good Manufacturing Practice (“cGMP”) and is a United States Drug Enforcement Agency (“DEA”) registered facility for research, development, manufacturing and packaging of pharmaceutical products. Elite’s analytical testing lab has extensive capabilities including chemical analysis, performance testing and physical characterization of actives, intermediates and finished drug products. Capabilities include, UV/Visible spectrophotometry, HPLC, UPLC, GC, polarimetry, tablet characterization, scanning electron microscopy, water sorption testing, and particle size testing. 

Elite’s proprietary abuse-deterrent technology utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. 

Elite owns, licenses, contract manufactures or receive royalties from the following products currently being sold commercially: Phentermine HCl 37.5mg tablets, Phendimetrazine Tartrate 35mg tablets, Phentermine HCl 15mg and 30mg capsules, Naltrexone HCl 50mg tablets, Isradipine 2.5mg and 5mg capsules, Oxycodone HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets, Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets, Dantrolene Sodium Capsules 25mg, 50mg and 100mg, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules, Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules. 

In December Elite filed an Abbreviated New Drug Application (ANDA) with the FDA for an undisclosed extended-release generic drug product in a class of medications called dopamine agonists. For the twelve months ending August 31, 2022, the dopamine agonist had total US sales of approximately $12 million, according to IQVIA data. 

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The Company is led by CEO Nasrat Hakim, a biotech executive with over 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended-release formulations and extensive regulatory experience of GMP and FDA regulations. Prior to his leading Elite, from 2004 to 2013, Mr. Hakim was employed by Actavis, Watson and Alpharma in various senior management positions. Most recently, Mr. Hakim served as International Vice President of Quality Assurance at Actavis, overseeing 25 sites with more than 3,000 employees under his leadership.  

In February the Company reported positive results from pivotal fasted bioequivalence studies for an undisclosed generic drug product in a class of medications called antimetabolites . IQVIA reported annual sales for the twelve months ending December 2022 of $42 million for the generic market for this product. The studies were open label, single-dose crossover comparative bioavailability studies in volunteers of male and female patients who were already on established drug regimens under fasting conditions. The results indicate that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration. 

On February 14 ELTP announced results for the third quarter of fiscal year 2023 ended December 31, 2022. Consolidated revenues for the three-month period ended December 31, 2022, were $9.3 million, an increase of $0.30 million or 3% as compared to the comparable period of the prior fiscal year. The increase was primarily attributed to revenues from generic immediate-release Adderall® and generic extended-release Adderall®. Operating profits were $2.0 million, an increase of $0.12 million from the prior year’s comparable period, and net income was $2.96 million. 

Consolidated revenues for the nine-month period ended December 31, 2022, were $25.5 million, an increase of $0.90 million or 4% as compared to the comparable period of the prior fiscal year. The increase was primarily attributed to revenues from generic immediate-release Adderall® and generic extended-release Adderall®. Operating profits were $4.1 million, a decrease of $0.10 million from the comparable period of the prior year, and net income was $4.79 million. Elite’s management held a conference call during which they discussed the Third Quarter financial results on February 15. Audio Replay: https://elite.irpass.com/events_presentations 

$ELTP Elite Pharmaceuticals, Inc. Reports Financial Results for the Third Quarter of Fiscal Year 2023 ended December 31, 2022 and Provides Conference Call Information https://t.co/QXECuI7xTg

— Bio/Tech Stock Focus (@MarcJacksonLA) February 15, 2023

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Currently trading at a $36 million market valuation ELTP OS is 1,013,915,081 with 715,116,499 shares in the public float. The Company has a very strong balance sheet with $18 million cash in the treasury, $52 million in assets vs. $22 million in liabilities, only $6 million of which are current. As we said, since the summer of 2019 ELTP has not diluted the stock and at that time ELTP ran to highs near $0.15 with a similar share structure to what it has today.  ELTP is an SEC filer fully reporting OTCQB with a long history of big moves and fast-growing sales recently reporting revenues for the nine-month period ended December 31, 2022, were $25.5 million and a net income of $4.8 million. In 2014 ELTP was the darling of small caps skyrocketing from current levels to well over $0.90 per share, also in December 2015 ELTP ran well over $0.40. We will be updating on ELTP when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

Disclosure: we hold no position in ELTP either long or short and we have not been compensated for this article.