{"url_path":"/sec/eltp/10-k/2026/item-1","section_key":"item-1","section_title":"Item 1 BUSINESS**","topic":"sec","document":{"doc_type":"10-K","doc_date":"2026-06-29","source_url":"https://www.sec.gov/Archives/edgar/data/1053369/0001493152-26-031070-index.html","accession_number":"0001493152-26-031070","cik":"0001053369","ticker":"ELTP","issuer_name":"ELITE PHARMACEUTICALS INC /NV/","edgar_url":"https://www.sec.gov/Archives/edgar/data/1053369/0001493152-26-031070-index.html","primary_entity_key":"0001053369","primary_entity_name":"ELITE PHARMACEUTICALS INC /NV/"},"word_count":11294,"has_tables":true,"body_markdown":"**ITEM\n1. BUSINESS**\n\n \n\n**General**\n\n \n\nElite\nPharmaceuticals, Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the\n“registrant”, “we”, “us” or “our”) was incorporated on October 1, 1997 under the laws\nof the State of Delaware, and its wholly-owned subsidiary, Elite Laboratories, Inc. (“Elite Labs”), was incorporated on August\n23, 1990 under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the\nState of Nevada.\n\n \n\nWe\nare a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, and\nthe manufacture of generic pharmaceuticals. Our strategy includes developing generic versions of controlled-release drug products with\nhigh barriers to entry.\n\n \n\nWe\noccupy manufacturing, warehouse, laboratory and office space at 135, 144, and 165 Ludlow Avenue in Northvale, NJ (the\n“Northvale Facility”). The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”)\nand is a United States Drug Enforcement Agency (“DEA”) registered facility for research, development, and manufacturing.\nOur website address is www.elitepharma.com.\n\n \n\n**Strategy**\n\n \n\nWe\nfocus our efforts on the following areas: (i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New\nDrug Applications (“ANDAs”); (ii) development of additional generic pharmaceutical products; (iii) development of the other\nproduct candidates in our pipeline including products co-developed with partners; (iv) commercial exploitation of our products either\nby sales under our own label, license and the collection of royalties, or through the manufacture of our formulations; and (v) development\nof new products for sale under our own label, and the expansion of our licensing agreements with other pharmaceutical companies, including\nco-development projects, joint ventures and other collaborations.\n\n \n\nWe\ncontinue to evaluate opportunities for the development of various types of drug products, including branded drug products which require\nNew Drug Applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration\nAct of 1984 (the “Drug Price Competition Act”) as well as generic drug products which require ANDAs.\n\n \n\nWe\nbelieve that our business strategy enables us to reduce our risk by having a diverse product portfolio.\n\n \n\n1\n\n \n\n** **\n\n**Commercial\nProducts**\n\n \n\nWe\nown, license, manufacture, sell, distribute or receive royalties from the following products currently being sold commercially:\n\n \n\n**Product**\n** **\n\n**Branded**\n\n**Product\nEquivalent**\n\n \n\n**Therapeutic**\n\n**Category**\n\n** **\n**Launch\nDate**\n\nPhentermine\nHCl 37.5mg tablets (“Phentermine 37.5mg”)\n \nAdipex-P®\n \nBariatric\n \nApril\n2011\n\nPhendimetrazine\nTartrate 35mg tablets (“Phendimetrazine 35mg”)\n \nBontril®\n \nBariatric\n \nNovember\n2012\n\nPhentermine\nHCl 15mg and 30mg capsules (“Phentermine 15mg” and “Phentermine 30mg”)\n \nAdipex-P®\n \nBariatric\n \nApril\n2013\n\nNaltrexone\nHCl 50mg tablets (“Naltrexone 50mg”)\n \nRevia®\n \nPain\n \nSeptember\n2013\n\nIsradipine\n2.5mg and 5mg capsules (“Isradipine 2.5mg” and “Isradipine 5mg”)\n \nN/A\n \nCardiovascular\n \nJanuary\n2015\n\nTrimipramine\nMaleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine\n100mg”)\n \nSurmontil®\n \nAntidepressant\n \nMay\n2017\n\nDextroamphetamine\nSaccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg,\n20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine\nIR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg” and “Amphetamine IR 30mg”)\n \nAdderall®\n \nCentral\nNervous System (“CNS”) Stimulant\n \nApril\n2019\n\nDantrolene\nSodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”)\n \nDantrium®\n \nMuscle\nRelaxant\n \nJune\n2019\n\nDextroamphetamine\nSaccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and\n30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine\nER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”)\n \nAdderall\nXR®\n \nCentral\nNervous System (“CNS”) Stimulant\n \nMarch\n2020\n\nLoxapine\nSuccinate 5mg, 10mg, 25mg and 50gm capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”,\nand Loxapine 50mg”)\n \nLoxapine®\n \nAntipsychotic\n \nMay\n2021\n\nMethotrexate\nSodium 2.5mg tablets (“Methotrexate 2.5mg”)\n \nOtrexup\nPF®\n \nAntimetabolite\n \nAugust\n2024\n\nAcetaminophen\nand Codeine Phosphate 300mg/15mg, 300mg/30mg, 300mg/60mg tablets (“APAP Codeine 300mg/15mg”, “APAP Codeine 300mg/30mg”,\nand “APAP Codeine 300mg/60mg”)\n \nTylenol®\nwith Codeine\n \nPain\n \nOctober\n2024\n\nAcetaminophen\nand Hydrocodone Bitartrate 325mg/2.5mg, 325mg/5mg, 325mg/7.5mg and 325mg/10mg tablets (“APAP Hydrocodone 325mg/2.5mg”,\n“APAP Hydrocodone 325mg/5mg”, APAP Hydrocodone 325mg/7.5mg and APAP Hydrocodone 325mg/10mg”)\n \nNorco®\n \nPain\n \nDecember\n2024\n\nLisdexamfetamine\nDimesylate 10mg, 20mg, 30mg, 40mg, 50mg, 60mg and 70mg capsules (“Lisdex 10mg”, “Lisdex 20mg”, “Lisdex\n30mg”, “Lisdex 40mg”, “Lisdex 50mg”, “Lisdex 60mg” and “Lisdex 70mg”)\n \nVyvanse®\n \nADHD\n \nDecember\n2024\n\nOxycodone\nHydrochloride and Acetaminophen 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets (“Oxy APAP 5/325”, “Oxy APAP 7.5/325”\nand “Oxy APAP 10/325”)\n \nPercocet®\n \nPain\n \n April\n2025\n\nMethadone\nHydrochloride 5mg and 10mg tablets (“Methadone 5mg” and “Methadone 10mg”)\n \nDolophine®\n \nPain\n \n April\n2026\n\n* *\n\n*Note:\nPhentermine 37.5mg is also referred to as “Phentermine Tablets”. Phentermine 15mg and Phentermine 30mg are collectively and\nindividually referred to as “Phentermine Capsules”. Phendimetrazine 35mg is also referred to as “Phendimetrazine Tablets”.\nNaltrexone 50mg is also referred to as “Naltrexone Tablets”. Isradipine 2.5mg and Isradipine 5mg are collectively and individually\nreferred to as “Isradipine Capsules”. Trimipramine 25mg, Trimipramine 50mg, and Trimipramine 100mg are collectively and individually\nreferred to as “Trimipramine Capsules”. Amphetamine IR 5mg, Amphetamine IR 7.5mg, Amphetamine IR 10mg, Amphetamine IR 12.5mg,\nAmphetamine IR 15mg, Amphetamine IR 20mg and Amphetamine IR 30mg are collectively and individually referred to as “Amphetamine\nIR Tablets”. Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg are collectively and individually referred to as “Dantrolene\nCapsules”. Amphetamine ER 5mg, Amphetamine ER 10mg, Amphetamine ER 15mg. Amphetamine ER 20mg, Amphetamine ER 25mg and Amphetamine\nER 30mg are collectively and individually referred to as “Amphetamine ER Capsules”. Loxapine 5gm, Loxapine 10mg, and Loxapine\n25mg, Loxapine 50mg are collectively and individually referred to as “Loxapine Capsules”, Vigabatrin 500mg is collectively\nand individually referred to as “Vigabatrin Powder”, Methotrexate 2.5mg” is collectively and individually referred\nto as “Methotrexate Tablets”, APAP Codeine 300mg/15mg, APAP Codeine 300mg/30mg, and APAP Codeine 300mg/60mg are collectively\nand individually referred to as “APAP Codeine Tablets, APAP Hydrocodone 325mg/2.5mg, APAP Hydrocodone 325mg/5mg, APAP Hydrocodone\n325mg/7.5mg and APAP Hydrocodone 325mg/10mg are collectively and individually referred to as “APAP Hydrocodone Tablets”,\nLisdex 10mg, Lisdex 20mg, Lisdex 30mg, Lisdex 40mg, Lisdex 50mg, Lisdex 60mg and Lisdex 70mg are collectively and individually referred\nto as “Lisdex Capsules” and Oxy APAP 5/325, Oxy APAP 7.5/325 and Oxy APAP 10/325 are collectively and individually referred\nto as “Oxy APAP Tablets”. Methadone 5mg and Methadone 10mg are collectively and individually referred to as “Methadone\nTablets” .*\n\n \n\n2\n\n \n\n* *\n\n*Phentermine\n37.5mg*\n\n \n\nThe\nCompany acquired two ANDAs for Phentermine 37.5mg, in 2010 and 2013, respectively.\n\n \n\nSales\nand marketing rights for Phentermine 37.5mg relating to the approved ANDA acquired in 2010 were licensed under an agreement between the\nCompany and Precision Dose Inc. (“Precision Dose”) dated September 10, 2010 (the “Precision Dose License Agreement”)\nand the Precision Dose License Agreement expired in accordance with its terms on September 10, 2025. The Company retains all sales and marketing rights for\nthis product.\n\n \n\nThe\nPhentermine 37.5mg product relating to the approved ANDA acquired in 2013 is currently a commercial product being manufactured at the\nNorthvale Facility and distributed by Elite Labs.\n\n \n\n*Phendimetrazine\nTartrate 35mg*\n\n \n\nThe\nANDA for Phendimetrazine was acquired by Elite in 2013.\n\n \n\nPhendimetrazine\n35mg is currently a commercial product being manufactured at the Northvale Facility and distributed by Elite Labs.\n\n \n\n*Phentermine\n15mg and Phentermine 30mg*\n\n \n\nPhentermine\n15mg capsules and Phentermine 30mg capsules were developed by the Company, with Elite receiving approval from the FDA of the related\nANDA in September 2012.\n\n \n\nSales\nand marketing rights for Phentermine 15mg and Phentermine 30mg are included in the Precision Dose License Agreement. Please see the section\nbelow titled “*Precision Dose License Agreement*” for further details of this agreement. The Precision Dose License\nAgreement expired in accordance with its terms on September 10, 2025. The Company retains all sales and marketing rights for this product.\n\n \n\nPhentermine\n15mg and Phentermine 30mg are currently commercial products being manufactured at the Northvale Facility and distributed by Elite Labs.\n\n \n\n*Naltrexone\n50mg*\n\n \n\nThe\nANDA for Naltrexone 50mg was acquired by Elite in 2010.\n\n \n\nSales\nand marketing rights for Naltrexone 50mg are included in the Precision Dose License Agreement. Please see the section below titled “*Precision\nDose License Agreement*” for further details of this agreement. The Precision Dose License Agreement expired in accordance with\nits terms on September 10, 2025.\n\n \n\nNaltrexone\n50mg is currently a commercial product being manufactured at the Northvale Facility and distributed by Elite Labs.\n\n \n\n*Isradipine\n2.5mg and Isradipine 5mg*\n\n \n\nThe\napproved ANDAs for Isradipine 2.5mg and Isradipine 5mg were acquired by Elite in 2013\n\n \n\nIsradipine\n2.5mg and Isradipine 5mg are commercial products being manufactured by Elite at the Northvale Facility and distributed by Elite Labs.\n\n \n\n3\n\n \n\n* *\n\n*Trimipramine\n25mg, Trimipramine 50mg and Trimipramine 100mg*\n\n \n\nThe\napproved ANDA for Trimipramine was acquired by Elite in 2017.\n\n \n\nTrimipramine\n25mg, Trimipramine 50mg and Trimipramine 100mg are a commercial product being manufactured by Elite at the Northvale Facility and distributed\nby Elite Labs.\n\n \n\n*Amphetamine\nIR Tablets*\n\n \n\nOn\nDecember 10, 2018, the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall®, an immediate-release\nmixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine\nSulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets. The product is a central nervous system stimulant\nand indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.\n\n \n\nAmphetamine\nIR Tablets are currently a commercial product being manufactured by Elite and distributed by Elite Labs.\n\n \n\nOn\nDecember 6, 2021, the Company executed a license and distribution agreement with Dexcel Ltd (or Akiva, Israel) (“Dexcel”),\npursuant to which the Company manufactures and supplies Amphetamine IR Tablets to Dexcel and Dexcel is granted exclusive distribution\nrights for the Israeli market for this product, under the Dexcel label (the “Dexcel Agreement”). The first shipment\nof Amphetamine IR Tablets pursuant to the Dexcel Agreement occurred in July 2025.\n\n \n\n*Amphetamine\nER Capsules*\n\n \n\nOn\nDecember 12, 2019, the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR®, an\nextended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine\nSulfate, Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg, and 30 mg tablets. The product is a central nervous system\nstimulant and is indicated for the treatment of ADHD and Narcolepsy.\n\n \n\nAmphetamine\nER Capsules are currently a commercial product being manufactured by Elite at the Northvale Facility and distributed by Elite Labs as\nwell as being manufactured by Elite at the Northvale Facility and distributed by Prasco, LLC (“Prasco”) pursuant to the non-exclusive\nlicense agreement between the Company and Prasco dated April 5, 2023 (the “Prasco Non-Exclusive License Agreement”).\n\n \n\n*Dantrolene\nCapsules*\n\n \n\nThe\napproved ANDAs for Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg (collectively, “Dantrolene Capsules”) were acquired\nby Elite in 2013. Dantrolene Capsules are a commercial product being manufactured by Elite at the Northvale Facility and distributed\nby Elite Labs.\n\n \n\n*Loxapine\nCapsules*\n\n \n\nThe\napproved ANDA for Loxapine was acquired by Elite in 2013.\n\n \n\nLoxapine\nSuccinate 5, 10, 25 and 50 mg are commercial products being manufactured by Elite at the Northvale Facility and distributed by Elite\nLabs.\n\n \n\nDuring\nthe year ended March 31, 2026, the Company recognized an impairment of the Loxapine Capsules, as a result of reassessments of the expected\nfuture cash flows for this product.\n\n \n\n*Methotrexate\nTablets*\n\n \n\nOn\nMay 20, 2024, the Company received approval from the FDA for Methotrexate Tablets, a product that belongs to the antimetabolite class\nof drugs. Methotrexate Tablets were commercially launched in August 2024 and are manufactured at the Northvale Facility and distributed\nby Elite Labs.\n\n \n\n*APAP\nCodeine Tablets*\n\n \n\nOn\nJune 17, 2024, the Company entered into an asset purchase agreement with Nostrum Laboratories Inc. (the “Nostrum Asset Purchase\nAgreement”), pursuant to which the Company acquired all rights in and to the approved ANDA for APAP Codeine Tablets and a royalty-free,\nnon-exclusive perpetual license to use the manufacturing technology, proprietary information, processes, techniques, protocols, methods,\nknow-how and improvements necessary or used to manufacture this product.\n\n \n\nAPAP\nCodeine Tablets were commercially launched in October 2024 and are manufactured at the Northvale Facility and distributed by Elite Labs.\n\n \n\n4\n\n \n\n* *\n\n*APAP\nHydrocodone Tablets*\n\n \n\nOn\nJune 17, 2024, pursuant to the Nostrum Asset Purchase Agreement, the Company acquired all rights in and to the approved ANDA to APAP\nHydrocodone Tablets and a royalty-free, non-exclusive perpetual license to use the manufacturing technology, proprietary information,\nprocesses, techniques, protocols, methods, know-how and improvements necessary or used to manufacture this product.\n\n \n\nAPAP\nHydrocodone Tablets were commercially launched in December 2024 and are manufactured at the Northvale Facility and distributed by Elite\nLabs.\n\n \n\n*Lisdex\nCapsules*\n\n \n\nOn\nNovember 18, 2024, the Company received approval from the FDA for Lisdex Capsules, a product indicated for the treatment of Attention\nDeficit Hyperactivity Disorder. Lisdex Capsules were commercially launched in December 2024 and are manufactured at the Northvale Facility\nand distributed by Elite Labs.\n\n \n\n*Oxy\nAPAP Tablets*\n\n \n\nOn\nJune 17, 2024, pursuant to the Nostrum Asset Purchase Agreement, the Company acquired all rights in and to the approved ANDA for Oxy\nAPAP Tablets and a royalty-free, non-exclusive perpetual license to use the manufacturing technology, proprietary information, processes,\ntechniques, protocols, methods, know-how and improvements necessary or used to manufacture this product.\n\n \n\nOxy\nAPAP Tablets were commercially launched in April 2025 and are manufactured at the Northvale Facility and distributed by Elite Labs.\n\n \n\n*Methadone\nTablets*\n\n \n\nOn\nJune 17, 2024, pursuant to the Nostrum Asset Purchase Agreement, the Company acquired all rights in and to the approved ANDA for Methadone\nTablets and a royalty-free, non-exclusive perpetual license to use the manufacturing technology, proprietary information, processes,\ntechniques, protocols, methods, know-how and improvements necessary or used to manufacture this product.\n\n \n\nMethadone\ntablets were commercially launched in April 2026 and are manufactured at the Northvale Facility and distributed by Elite Labs.\n\n \n\n**Products\nUnder FDA Review**\n\n \n\n*SequestOx™\n- Immediate Release Oxycodone with sequestered Naltrexone*\n\n \n\nSequestOx™\nis our abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. SequestOx™\nis an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5mg, 10mg, 15mg, 20mg and 30mg doses\nof oxycodone into capsules.\n\n \n\nIn\nJanuary 2016, the Company submitted a 505(b)(2) New Drug Application for SequestOx™, after receiving a waiver of the $2.3 million\nfiling fee from the FDA. In March 2016, the Company received notification of the FDA’s acceptance of this filing and that such\nfiling has been granted priority review by the FDA with a target action under the Prescription Drug User Fee Act (“PDUFA”)\nof July 14, 2016.\n\n \n\nOn\nJuly 15, 2016, the FDA issued a Complete Response Letter, (“CRL”), regarding the NDA. The CRL stated that the review cycle\nfor the SequestOx™ NDA was complete and the application is not ready for approval in its present form.\n\n \n\nOn\nJuly 7, 2017, the Company reported topline results from a pivotal bioequivalence fed study for SequestOx™. The mean Tmax (the amount\nof time that a drug is present at the maximum concentration in serum) of SequestOx™ was 4.6 hr. with a range of 0.5 hr. to 12 hr.\nand the mean Tmax of the comparator, Roxicodone®, was 3.4 hr. with a range of 0.5 hr. to 12 hr. A key objective for the study was\nto determine if the reformulated SequestOx™ had a similar Tmax to the comparator when taken with a high fat meal. Based on these\nresults, the Company paused clinical trials for this formulation of SequestOx™. On January 30, 2018, the Company reported positive\ntopline results from a pilot study conducted for a modified SequestOx™ wherein, based on the results of this pilot study, the modified\nSequestOx™ formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted\nin a pivotal trial under fed conditions. The Company has provided the pilot data to the FDA, requesting clarification as to the requirements\nfor resubmission of the NDA. The FDA has provided guidance for repeated bio-equivalence studies in order to bridge the new formulation\nto the original SequestOx™ studies. Due to the prohibitive cost of such repeated bio-equivalence studies and the uncertain commercial\nviability given the regulatory and competitive landscape, the Company has paused development of this product candidate.\n\n \n\n5\n\n \n\n \n\nThere\ncan be no assurances of the Company conducting future clinical trials, or if such trials are conducted, there can be no assurances of\nthe success of any future clinical trials, or if such trials are successful, there can be no assurances that an intended future resubmission\nof the NDA product filing, if made, will be accepted by or receive marketing approval from the FDA. In addition, even if marketing authorization\nis received, there can be no assurances that there will be future revenues or profits, or that any such future revenues or profits would\nbe in amounts that provide adequate return on the significant investments made to secure this marketing authorization.\n\n \n\n*Generic\nProducts Filed*\n\n \n\nCurrently\nthe Company has filed the following ANDAs which have been accepted for review by the FDA:\n\n \n\n \n●\nA generic opiate analgesic for pain management accepted for\nreview in September 2023\n\n \n\n \n●\nA generic anticoagulant which was filed with the FDA in May\n2026 and for which the Company is awaiting the FDA’s acceptance for review.\n\n \n\n**Approved\nProducts Not Yet Commercialized**\n\n \n\n*Doxycycline\nHyclate Tablets*\n\n \n\nThe\nCompany received approval in April 2022 from the FDA of an ANDA for a generic version of an antibiotic product, Doxycycline Hyclate Tablets.\nThe product is jointly owned by Elite and Praxgen Pharmaceuticals LLC, formerly SunGen Pharma LLC, (“Praxgen”).\n\n \n\n*Ropinirole\nER*\n\n \n\nThe\nCompany received approval in November 2025 for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP) (“Ropinirol\nTablets”). Ropinirole belongs to a class of drugs known as a non-ergoline dopamine used to treat symptoms of Parkinson’s\ndisease.\n\n \n\nThere\ncan be no assurances in relation to any of the above approved products not yet commercialized, that there will be future revenues of\nprofits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments\nmade to secure these marketing authorizations.\n\n \n\n**Discontinued\nand Transferred Products**\n\n \n\nAs\npart of standard operating practices, the Company, from time to time, as relevant, conducts evaluations of all ANDAs owned, consisting,\nwithout limitation, of ANDAs acquired or approved prior to the fiscal year ended March 31, 2026 (“Fiscal 2026”) and ANDAs\nacquired or approved during the Fiscal 2026. Such evaluations include, without limitation, costs and benefits relating to each ANDA owned,\nwith such costs including those fees required under the FDA’s Generic Drug User Fee Amendment which is significantly influenced\nby the number of ANDAs owned, and other costs and benefits taking into consideration various specific market factors for each ANDA. Those\nANDAs with a cost/benefit profile not consistent with management criteria for continuation are identified for disposition and effort\nis made to determine the optimal course of action to achieve disposition of the ANDA.\n\n \n\nDuring\nthe year ended March 31, 2026, the Company moved ANDAs for Phentermine 15mg and Phentermine 30mg onto the discontinued list as it does\nnot intend to engage in commercial operations with these products at this time. Elite continues to sell Phentermine 15mg and Phentermine\n30mg, however, with a different ANDA that remains active.\n\n** **\n\n6\n\n \n\n** **\n\n**Licensing,\nManufacturing and Development Agreements**\n\n \n\n*Precision\nDose License Agreement*\n\n \n\nOn\nSeptember 10, 2010, the Company executed the Precision Dose License Agreement to market and distribute Phentermine 37.5mg, Phentermine\n15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional products that require approval from the FDA, through\nits wholly-owned subsidiary, TAGI, in the United States, Puerto Rico and Canada. Phentermine 37.5mg was launched in April 2011. Hydromorphone\n8mg was launched in March 2012. Phentermine 15mg and Phentermine 30mg were launched in April 2013. Naltrexone 50mg was launched in September\n2013. Precision Dose had the exclusive right to market these products in the United States and Puerto Rico and a non-exclusive right\nto market the products in Canada.\n\n \n\nPursuant\nto the Precision Dose License Agreement, Elite received a license fee and milestone payments. The license fee was computed as a percentage\nof the gross profit, as defined in the Precision Dose License Agreement, earned by Precision Dose as a result of sales of the products.\nThe license fee was payable monthly for the term of the Precision Dose License Agreement. The milestone payments consisted of payments\ndue upon execution of the Precision Dose License Agreement and upon FDA approval and initial shipments of products to Precision Dose.\n\n \n\nThe\nPrecision Dose License Agreement had an initial term of 15 years and expired in accordance with its terms, on September\n10, 2025.\n\n \n\n*Prasco\nNon-Exclusive License Agreement*\n\n \n\nOn\nApril 5, 2023, the Company entered into a non-exclusive license agreement to manufacture, supply and distribute with Prasco, LLC and\nits affiliate Burel to distribute generic mixed amphetamine extended-release capsules in the United States. The agreement commenced on\nJanuary 1, 2024 and was terminated with notice on March 31, 2025.\n\n \n\n*Pyros\nManufacturing and Supply Agreement*\n\n \n\nIn\nconjunction with the sale of its Product to Pyros, the Company executed a Manufacturing and Supply Agreement (the “Pyros Agreement”)\nwith Pyros on November 21, 2002. Under the terms of the Pyros Agreement, the Company received an agreed-upon price per drug for the manufacturing\nand packaging of Sabril. Revenue per the Pyros Agreement was recognized as control of the manufactured and supplied drugs is transferred\nto Pyros (at the time of delivery). The Pyros Agreement was terminated by mutual agreement on January 10, 2025.\n\n \n\n*Dexcel Agreement for Israel*\n\n \n\nOn\nDecember 6, 2021, the Company entered into the Dexcel Agreement for Amphetamine IR 10mg, Amphetamine IR 20mg and Amphetamine\nIR 30mg. Pursuant to the Dexcel Agreement, Elite manufactures and packages the product under Dexcel’s label. Dexcel provides\nsales, marketing and distribution. Dexcel pays an agreed upon transfer price for the product and shares any profits when the net selling\nprice exceeds a floor price, as defined in the Dexcel Agreement. The first shipment of product under this agreement was made in July\n2025.\n\n \n\n**Products\nUnder Development**\n\n \n\nElite’s\nresearch and development activities include developing its proprietary abuse-deterrent technology and the development of a range of abuse-deterrent\nopioid products that utilize this technology or other approaches to abuse deterrence.\n\n \n\nElite’s\nproprietary abuse-deterrent technology utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate\ncapsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol\ndependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased\nwhile the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads\nare crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to\nblock the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive\nfor abuse or misuse by recreational drug abusers.\n\n \n\nThe\nCompany filed an NDA for the first product to utilize our abuse-deterrent technology, Immediate Release Oxycodone 5mg, 10mg, 15mg, 20mg\nand 30mg with sequestered Naltrexone (collectively and individually referred to as “SequestOx™”), on January 14, 2016.\nPlease see “Filed products under FDA review; SequestOx™ - Immediate Release Oxycodone with sequestered Naltrexone”\nabove and please note that continued development of this product is currently paused.\n\n \n\nThe\nCompany is currently evaluating the marketplace when deciding to proceed with the above listed filed application.\n\n \n\n7\n\n \n\n \n\nPlease\nnote that, while the FDA is required to review applications within certain timeframes, during the review process, the FDA frequently\nrequests that additional information be submitted. The effect of such requests and subsequent submissions can significantly extend the\ntime for the FDA review process. Until a product is actually approved, there can be no assurances that the information requested and\nsubmitted will be considered adequate by the FDA to justify approval. The packaging and labeling of our approved products are also subject\nto FDA regulation. Based on the foregoing, it is impossible to anticipate the amount of time that will be needed to obtain FDA approval\nand to commercialize a product, if approved. In addition, there can be no assurances of the Company filing the required application(s)\nwith the FDA or of the FDA approving such application(s) if filed. The Company’s ability to successfully develop and commercialize\nproducts incorporating its abuse-deterrent technology is subject to a high level of risk as detailed in “Item 1A-Risk Factors-Risks\nRelated to our Business” of this Annual Report on Form 10-K.\n\n \n\n**Abuse-Deterrent\nand Sustained Release Opioids**\n\n \n\nThe\nabuse-deterrent opioid products utilize our patented abuse-deterrent technology that is based on a pharmacological approach. These products\nare combinations of a narcotic agonist formulation intended for use in patients with pain, and an antagonist, formulated to deter abuse\nof the drug. Both, agonist, and antagonist, have been on the market for a number of years and sold separately in various dose strengths.\n\n \n\nThe\nCompany is currently not selling abuse-deterrent and sustained release opioids and is evaluating the market place when deciding to proceed\nwith the above listed filed applications.\n\n \n\n**Patents**\n\n \n\nThe\nCompany owns the following patents (as of March 31, 2026):\n\n \n\n**PATENT**\n** **\n**EXPIRATION\nDATE**\n\nU.S.\npatent 9,056,054\n \nJune\n2030\n\nU.S.\npatent 10,213,388\n \nJune\n2030\n\n \n\nWe\nintend to apply for patents for other products in the future; however, there can be no assurance that any of the pending applications\nor other applications which we may file will be granted. We have also filed corresponding foreign applications for key patents.\n\n \n\nPrior\nto the enactment in the United States of new laws adopting certain changes mandated by the General Agreement on Tariffs and Trade (“GATT”),\nthe exclusive rights afforded by a U.S. Patent were for a period of 17 years measured from the date of grant. Under GATT, the term of\nany U.S. Patent granted on an application filed subsequent to June 8, 1995 terminates 20 years from the date on which the patent application\nwas filed in the United States or the first priority date, whichever occurs first. Future patents granted on an application filed before\nJune 8, 1995, will have a term that terminates 20 years from such date, or 17 years from the date of grant, whichever date is later.\n\n \n\nUnder\nthe Drug Price Competition Act, a U.S. product patent or use patent may be extended for up to five years under certain circumstances\nto compensate the patent holder for the time required for FDA regulatory review of the product. Such benefits under the Drug Price Competition\nAct are available only to the first approved use of the active ingredient in the drug product and may be applied only to one patent per\ndrug product. There can be no assurance that we will be able to take advantage of this law.\n\n \n\nAlso,\ndifferent countries have different procedures for obtaining patents, and patents issued by different countries provide different degrees\nof protection against the use of a patented invention by others. There can be no assurance, therefore, that the issuance to us in one\ncountry of a patent covering an invention will be followed by the issuance in other countries of patents covering the same invention,\nor that any judicial interpretation of the validity, enforceability, or scope of the claims in a patent issued in one country will be\nsimilar to the judicial interpretation given to a corresponding patent issued in another country. Furthermore, even if our patents are\ndetermined to be valid, enforceable, and broad in scope, there can be no assurance that competitors will not be able to design around\nsuch patents and compete with us using the resulting alternative technology.\n\n \n\nDuring the year ended\nMarch 31, 2026, a patent related to the Company’s abuse deterrent opioid technology expired before marketing authorization was obtained\nfrom the FDA, and therefore all capitalized costs related to the application of this patent were impaired in full during the year ended\nMarch 31, 2026. Refer to Note 4 of our consolidated financial statements for additional information.\n\n \n\n**Trademarks**\n\n \n\nSequestOx™\nis a trademark owned by Elite.\n\n \n\nWe\ncurrently plan to license at least some of our products to other entities in the marketing of pharmaceuticals but may also sell products\nunder our own brand name in which case we may register trademarks for those products.\n\n \n\nElite\nsells its own products under an “Elite Labs” label.\n\n \n\n8\n\n \n\n** **\n\n**Other\nBusiness Factors and Details**\n\n \n\n*Government\nRegulation and Approval*\n\n \n\nThe\ndesign, development, manufacturing, and marketing of pharmaceutical compounds, on which our success depends, are intensely regulated\nby governmental regulatory agencies, in particular the FDA and DEA. Non-compliance with applicable requirements can result in fines and\nother judicially imposed sanctions, including product seizures, injunction actions and criminal prosecution based on products or manufacturing\npractices that violate statutory requirements. In addition, administrative remedies can involve voluntary withdrawal of products, as\nwell as the refusal of the FDA to approve ANDAs and NDAs. The FDA also has the authority to withdraw approval of drugs in accordance\nwith statutory due process procedures.\n\n \n\nBefore\na drug may be marketed, it must be approved by the FDA either through an NDA or an ANDA, each of which is discussed below.\n\n \n\n*NDAs\nand NDAs under Section 505(b)(2) of the Drug Price Competition Act*\n\n \n\nThe\nFDA approval procedure for an NDA is generally a two-step process. During the initial product development stage, an investigational new\ndrug application (“IND”) for each product is filed with the FDA. The IND contains results of animal and in vitro studies\nassessing the toxicology, pharmacokinetic, pharmacological, and pharmacodynamics characteristics of the product candidate; chemistry,\nmanufacturing, and controls information; and any available human data or literature to support the use of the product candidate. A 30-day\nwaiting period after the filing of each IND is required by the FDA prior to the commencement of initial clinical testing. If the FDA\ndoes not comment on or question the IND within such 30-day period, initial clinical studies may begin. If, however, the FDA has comments\nor questions, they must be answered to the satisfaction of the FDA before initial clinical testing may begin. In some instances, this\nprocess could result in substantial delay and expense. Clinical trials are typically conducted in three sequential phases that may overlap\nor be combined:\n\n \n\n*Phase\nOne*: The product candidate is initially introduced into healthy human subjects or patients with the target disease or condition.\nThese studies are designed to test the safety, dosage tolerance, absorption, metabolism, and distribution of the investigational product\nin humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. In the case\nof some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer\nto healthy volunteers, the initial human testing;\n\n \n\n*Phase\nTwo*: The product candidate is administered to a limited patient population with a specified disease or condition to evaluate the\npreliminary efficacy, optimal dosages, and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase\n2 clinical trials may be conducted to obtain information prior to beginning;\n\n \n\n*Phase\nThree*: The product candidate is administered to an expanded patient population to further evaluate dosage, to provide statistically\nsignificant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial\nsites. These clinical trials are intended to establish the overall risk.\n\n \n\nConcurrent\nwith clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry\nand physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance\nwith cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate\nand, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final drug.\nIn addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product\ncandidate does not undergo unacceptable deterioration over its shelf life.\n\n \n\nAssuming\nsuccessful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development\nnonclinical and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of\nthe drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the\nproduct. The submission of an NDA is subject to the payment of substantial user fees; a waiver of such fees may be obtained under certain\nlimited circumstances.\n\n \n\nThe\nFDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing\nis cGMP-compliant to assure and preserve the product’s identity, strength, quality, and purity. Under the Prescription Drug User\nFee Act (“PDUFA”) guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing”\nof a standard NDA for a new molecular entity to review and act on the submission. This review typically takes 12 months from the date\nthe NDA is submitted to FDA because the FDA has approximately two months to make a “filing” decision after the application\nis submitted. The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for\nfiling, to determine whether they are sufficiently complete to permit substantive review The FDA may request additional information rather\nthan accept an NDA for filing. In this event, the NDA must be resubmitted with the additional information. The resubmitted application\nis also subject to review before the FDA accepts it for filing.\n\n \n\nThe\nFDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including\nclinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be\napproved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations\ncarefully when making decisions.\n\n \n\n9\n\n \n\n \n\nBefore\napproving an NDA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve\nan application unless it determines that the manufacturing processes and facilities are in compliance with cGMP and adequate to assure\nconsistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect\none or more clinical sites to assure compliance with good clinical practices (“GCPs”). If the FDA determines that the application,\nmanufacturing process, or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will\nrequest additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately\nmay decide that the application does not satisfy the regulatory criteria for approval.\n\n \n\nAfter\nthe FDA evaluates an NDA, it will issue an approval letter or a CRL. An approval letter authorizes commercial marketing of the drug with\nprescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete,\nand the application will not be approved in its present form. A Complete Response Letter usually describes the specific deficiencies\nin the NDA identified by the FDA and may require additional clinical data, such as an additional pivotal Phase 3 clinical trial or other\nsignificant and time-consuming requirements related to clinical trials, nonclinical studies, or manufacturing. If a Complete Response\nLetter is issued, the sponsor must resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application.\nEven if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval.\n\n \n\nIf\nregulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the\nindicated uses for which such product may be marketed. For example, the FDA may approve the NDA with a Risk Evaluation and Mitigation\nStrategy (“REMS”) to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known\nor potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their\nsafe use. It could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution\nmethods, patient registries, and other risk minimization tools. The FDA also may offer conditional approval subject to, among other things,\nchanges to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product\napproval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the\nmarketplace. The FDA may also require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s\nsafety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing\nstudies. In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s\npolicies may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.\n\n \n\nThe\nFDA closely regulates the marketing, labeling, advertising, and promotion of drug products. A company can make only those claims relating\nto safety and efficacy that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies\nactively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can\nresult in, among other things, adverse publicity, warning letters, corrective advertising, and potential civil and criminal penalties.\nPhysicians may prescribe, in their independent professional medical judgment, legally available products for uses that are not described\nin the product’s labeling and that differ from those tested by us and approved by the FDA. Physicians may believe that such off-label\nuses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their\nchoice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.\nThe federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and\nhas enjoined companies from engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies\nenter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. However, companies\nmay share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labeling.\n\n \n\nWhether\nor not FDA approval has been obtained, approval of the product by comparable regulatory authorities in any foreign country must be obtained\nprior to the commencement of marketing of the product in that country. We intend to conduct all marketing in territories other than the\nUnited States through other pharmaceutical companies based in those countries. The approval procedure varies from country to country,\ncan involve additional testing, and the time required may differ from that required for FDA approval. Although there are some procedures\nfor unified filings for certain European countries, in general each country has its own procedures and requirements, many of which are\ntime consuming and expensive. Thus, there can be substantial delays in obtaining required approvals from both the FDA and foreign regulatory\nauthorities after the relevant applications are filed. After such approvals are obtained, further delays may be encountered before the\nproducts become commercially available.\n\n \n\n*NDAs\nunder Section 505(b)(2)*\n\n \n\nSection\n505(b)(2) NDAs may provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved products.\nSection 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from clinical trials\nnot conducted by, or for, the applicant and for which the applicant has not obtained a right of reference. The FDA may then approve the\nnew product candidate for all, or some, of the label indications for which the referenced product has been approved, as well as for any\nnew indication sought by the Section 505(b)(2) applicant.\n\n \n\n10\n\n \n\n \n\nTo\nthe extent that the Section 505(b)(2) applicant is relying on the FDA’s findings of safety and effectiveness for an already approved\nproduct, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to\nthe same extent that an ANDA applicant would. Thus approval of a Section 505(b)(2) NDA can be stalled until all the listed patents claiming\nthe referenced product have expired; until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity\n(“NCE”), listed in its publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” also referred\nto as the “Orange Book”, for the referenced product has expired; and, in the case of a Paragraph IV certification and subsequent\npatent infringement suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case that is favorable\nto the Section 505(b)(2) applicant. In the interim period, the FDA may grant tentative approval. Tentative approval indicates that the\nFDA has determined that the applicant meets the standards for approval as of the date that the tentative approval is granted. Final regulatory\napproval can only be granted if the FDA is assured that there is no new information that would affect final regulatory/ approval.\n\n \n\n*ANDAs*\n\n \n\nTo\nobtain approval of a generic drug, an applicant must submit an ANDA, to the FDA. An ANDA is a comprehensive submission that contains,\namong other things, data and information pertaining to the active pharmaceutical ingredient, bioequivalence, drug product formulation,\nspecifications and stability of the generic drug, as well as analytical methods, manufacturing process validation data and quality control\nprocedures. ANDAs are “abbreviated” because they cannot include preclinical and clinical data to demonstrate safety and effectiveness.\nInstead, in support of such applications, a generic manufacturer must rely on the preclinical and clinical testing previously conducted\nfor a drug product previously approved under an NDA, known as the reference listed drug (“RLD”).\n\n \n\nIn\norder for an ANDA to be approved, the FDA must find that the generic version is identical to the RLD with respect to the active ingredients,\nroute of administration, dosage form, strength of the drug and conditions of use of the drug. At the same time, the FDA must also determine\nthat the generic drug is “bioequivalent” to the innovator drug. Under the statute, a generic drug is bioequivalent to a RLD\nif “the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of\nthe listed drug.” Upon approval of an ANDA, the FDA indicates whether the generic product is “therapeutically equivalent”\nto the RLD in the Orange Book. Physicians and pharmacists consider a therapeutic equivalent generic drug to be fully substitutable for\nthe RLD. In addition, by operation of certain state laws and numerous health insurance programs, the FDA’s designation of therapeutic\nequivalence often results in substitution of the generic drug without the knowledge or consent of either the prescribing physician or\npatient.\n\n \n\nWhen\nan ANDA applicant submits its application, it is required to certify to the FDA concerning any patents listed for the reference product\nin the Orange Book. Specifically, the ANDA applicant must certify that: (i) the required patent information has not been filed; (ii)\nthe listed patent has expired; (iii) the listed patent has not expired, but will expire on a particular date and approval is sought after\npatent expiration; or (iv) the listed patent is invalid or will not be infringed by the new product.\n\n \n\nIf\nthe follow-on applicant does not challenge the innovator’s listed patents, FDA will not approve the ANDA until all the listed patents\nclaiming the referenced product have expired. A certification that the new product will not infringe the already approved product’s\nlisted patents, or that such patents are invalid, is called a Paragraph IV certification. If the follow-on applicant has provided a Paragraph\nIV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once\nthe ANDA has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response\nto the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph\nIV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration of the patent, settlement\nof the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant.\n\n \n\nIn\nMay 1992, Congress enacted the Generic Drug Enforcement Act of 1992, which allows the FDA to impose debarment and other penalties on\nindividuals and companies that commit certain illegal acts relating to the generic drug approval process. In some situations, the Generic\nDrug Enforcement Act requires the FDA to not accept or review ANDAs for a period of time from a company or an individual that has committed\ncertain violations. It also provides for temporary denial of approval of applications during the investigation of certain violations\nthat could lead to debarment and also, in more limited circumstances, provides for the suspension of the marketing of approved drugs\nby the affected company. Lastly, the Generic Drug Enforcement Act allows for civil penalties and withdrawal of previously approved applications.\nNeither we nor any of our employees have ever been subject to debarment. We do not believe that we receive any services from any debarred\nperson.\n\n \n\n11\n\n \n\n* *\n\n*Controlled\nSubstances*\n\n \n\nThe\nfederal Controlled Substances Act of 1970 (“CSA”) and its implementing regulations establish a “closed system”\nof regulations for controlled substances. The CSA imposes registration, security, recordkeeping and reporting, storage, manufacturing,\ndistribution, importation, exportation, disposal and other requirements under the oversight of the DEA. The DEA is the federal agency\nresponsible for regulating controlled substances, and requires those individuals or entities that manufacture, import, export, distribute,\nresearch, or dispense controlled substances to comply with the regulatory requirements in order to prevent the diversion of controlled\nsubstances to illicit channels of commerce.\n\n \n\nThe\nDEA categorizes controlled substances into one of five schedules — Schedule I, II, III, IV or V — with\nvarying qualifications for listing in each schedule. Schedule I substances by definition have a high potential for abuse, have no currently\naccepted medical use in treatment in the United States and lack accepted safety for use under medical supervision. Pharmaceutical products\nhaving a currently accepted medical use that are otherwise approved for marketing may be listed as Schedule II, III, IV or V substances,\nwith Schedule II substances presenting the highest potential for abuse and physical or psychological dependence, and Schedule V substances\npresenting the lowest relative potential for abuse and dependence. The regulatory requirements are more restrictive for Schedule II substances\nthan Schedule III-V substances.\n\n \n\nFacilities\nthat manufacture, distribute, import or export any controlled substance must register annually with the DEA. The DEA registration is\nspecific to the particular location, activity(ies) and controlled substance schedule(s). For example, separate registrations are required\nfor importation and manufacturing activities, and each registration authorizes which schedules of controlled substances the registrant\nmay handle. Certain coincident activities are permitted without obtaining a separate DEA registration, however, such as distribution\nof controlled substances by the manufacturer that produces them.\n\n \n\nThe\nDEA inspects all manufacturing facilities to review security, recordkeeping, reporting and handling prior to issuing a controlled substance\nregistration. The specific security requirements vary by the type of business activity and the schedule and quantity of controlled substances\nhandled. The most stringent requirements apply to manufacturers of Schedule I and Schedule II substances. Required security measures\ncommonly include background checks on employees and physical control of controlled substances through storage in approved vaults, safes\nand cages, and through use of alarm systems and surveillance cameras. Once registered, manufacturing facilities must maintain records\ndocumenting the manufacture, receipt and distribution of all controlled substances. Manufacturers must submit periodic reports to the\nDEA of the distribution of Schedule I and II controlled substances, Schedule III narcotic substances, and other designated substances.\nRegistrants must also report any controlled substance thefts or significant losses, and must obtain authorization to destroy or dispose\nof controlled substances.\n\n \n\nFor\ndrugs manufactured in the United States, the DEA annually establishes an aggregate quota for the amount of substances within Schedules\nI and II that may be manufactured or produced in the United States based on the DEA’s estimate of the quantity needed to meet legitimate\nmedical, scientific, research and industrial needs. The quotas apply equally to the manufacturing of the active pharmaceutical ingredient\nand production of dosage forms. The DEA may adjust aggregate production quotas, and individual manufacturing or procurement quotas from\ntime to time, although the DEA has substantial discretion in whether or not to make such adjustments for individual companies. The DEA\nquota system was amended in 2018 to require sponsors to strengthen controls over diversion of controlled substances, controls and limits\nthe availability and production of controlled substances in Schedule I or II.\n\n \n\nFederal\nlaws have been enacted to address the national epidemics of prescription opioid abuse and illicit opioid use. In 2016, the Comprehensive\nAddiction and Recovery Act (“CARA”), was enacted to address the national epidemics of prescription opioid abuse and heroin\nuse. CARA expands the availability of naloxone for law enforcement and other first responders, forms an interagency task force to develop\nbest practices for pain management with opioid medications and provides resources to improve state monitoring of opioids. The Substance\nUse-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”), which\nwas signed into law in November 2018, includes a number of measures directed towards regulation and improvement of treatment for substance\nuse-disorder and increased coverage by Centers for Medicare and Medicaid Services (“CMS”) of medically-assisted treatment\noptions. In addition, the SUPPORT Act requires HHS to report to Congress on existing barriers to access to abuse-deterrent opioid formulations\nby Medicare Part C and D beneficiaries\n\n \n\nThe\nstates also maintain separate controlled substance laws and regulations, including licensing, recordkeeping, security, distribution,\nand dispensing requirements. State authorities, including Boards of Pharmacy, regulate use of controlled substances in each state. Failure\nto maintain compliance with applicable requirements, particularly as manifested in the loss or diversion of controlled substances, can\nresult in enforcement action that could have a material adverse effect on business, operations and financial conditions. The DEA may\nseek civil penalties, refuse to renew necessary registrations, or initiate proceedings to revoke those registrations. In certain circumstances,\nviolations could lead to criminal prosecution.\n\n \n\n12\n\n \n\n* *\n\n*Other\nHealthcare Laws and Compliance Requirements*\n\n \n\nOur\nactivities are subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute,\nthe federal civil False Claims Act, and laws and regulations pertaining to limitations on and reporting of healthcare provider payments\n(physician sunshine laws). These laws and regulations are interpreted and enforced by various federal, state and local authorities including\nCMS, the Office of Inspector General for the U.S. Department of Health and Human Services, the U.S. Department of Justice, individual\nU.S. Attorney offices within the Department of Justice, and state and local governments. These laws include:\n\n \n\n \n●\nthe\nU.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting,\noffering, receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward\neither the referral of an individual for, or the purchase, lease, order, or arranging for or recommending the purchase, lease or\norder of, any good or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare\nand Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order\nto have committed a violation;\n\n \n\n \n●\nthe\nU.S. civil False Claims Act (which can be enforced through “qui tam,” or whistleblower actions, by private citizens on\nbehalf of the federal government and impose civil and criminal penalties), prohibits any person from, among other things, knowingly\npresenting, or causing to be presented false or fraudulent claims for payment of government funds or knowingly making, using or causing\nto be made or used, a false record or statement material to an obligation to pay money to the government or knowingly and improperly\navoiding, decreasing or concealing an obligation to pay money to the U.S. federal government;\n\n \n\n \n●\nU.S.\nfederal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal liability and amends provisions\non the reporting, investigation, enforcement, and penalizing of civil liability for, among other things, knowingly and willfully\nexecuting, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing\nor covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for healthcare\nbenefits, items or services by a healthcare benefit program, which includes both government and privately funded benefits programs;\nsimilar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific\nintent to violate it in order to have committed a violation;\n\n \n\n \n●\nHIPAA,\nas amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations,\nwhich also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission\nof individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as\nhealth plans, healthcare clearinghouses and healthcare providers as well as their business associates and their subcontractors that\nperform certain services for or on their behalf involving the use or disclosure of individually identifiable health information;\n\n \n\n \n●\nstate\nlaws and regulations, including state anti-kickback and false claims laws, that may apply to our business practices, including but\nnot limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed\nby any third-party payer, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical\nindustry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government,\nor otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws and\nregulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking\ngifts and other remuneration and items of value provided to healthcare professionals and entities; and\n\n \n\n \n●\nthe\nPhysician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, requires certain manufacturers\nof drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health\nInsurance Program to report annually to CMS information related to certain payments made in the preceding calendar year and other\ntransfers of value to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their\nimmediate family members; beginning in 2022, applicable manufacturers are required to report such information regarding payments\nand transfers of value provided, as well as ownership and investment interests held, during the previous year to physician assistants,\nnurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.\n\n \n\n13\n\n \n\n \n\nViolations\nof any of these laws or any other governmental regulations that may apply to us, may subject us to significant civil, criminal and administrative\nsanctions including penalties, damages, fines, imprisonment, and exclusion from government funded healthcare programs, such as Medicare\nand Medicaid, and/or adverse publicity.\n\n \n\nMoreover,\ngovernment entities and private litigants have asserted claims under state consumer protection statutes against pharmaceutical companies\nfor alleged false or misleading statements in connection with the marketing, promotion and/or sale of pharmaceutical products, including\nstate investigations and litigation by certain government entities regarding the marketing of opioid products.\n\n \n\n*Foreign\nCorrupt Practices Act*\n\n \n\nThe\nForeign Corrupt Practices Act (“FCPA”), generally prohibits offering, promising, giving, or authorizing others to give anything\nof value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain\nor retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the\ntransactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our industry is heavily\nregulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally,\nin many other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers\nof pharmaceuticals are government entities; therefore, our dealings with these prescribers and purchasers are subject to regulation under\nthe FCPA. Recently, the SEC and DOJ have increased their FCPA enforcement activities with respect to pharmaceutical companies. Violations\ncould result in fines, criminal sanctions against us, our officers, or our employees, the closing down of our facilities, requirements\nto obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions\non the conduct of our business. Enforcement actions may be brought by the DOJ or the SEC, and legislation has expanded the SEC’s\npower to seek disgorgement in all FCPA cases filed in federal court and extended the statute of limitations in SEC enforcement actions\nin intent-based claims such as those under the FCPA from five years to ten years.\n\n \n\n*Coverage\nand Reimbursement*\n\n \n\nSales\nof any pharmaceutical product depend, in part, on the extent to which such product will be covered by third-party payors, such as federal,\nstate, and foreign government healthcare programs, commercial insurance, and managed healthcare organizations, and the level of reimbursement\nfor such product by third-party payors. Significant uncertainty exists as to the coverage and reimbursement status of any newly approved\nproduct. Decisions regarding the extent of coverage and amount of reimbursement to be provided for any product are made on a plan-by-plan\nbasis. One third-party payor’s decision to cover a particular product does not ensure that other payors will also provide coverage\nfor the product. As a result, the coverage determination process can require manufacturers to provide scientific details, information\non cost-effectiveness, and clinical support for the use of a product to each payor separately. This can be a time-consuming process,\nwith no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.\n\n \n\nIn\naddition, third-party payors are increasingly reducing reimbursements for pharmaceutical products and related services. The U.S. government\nand state legislatures have continued implementing cost-containment programs, including price controls and restrictions on coverage and\nreimbursement. Third-party payors are increasingly challenging the prices charged, examining the medical necessity and reviewing the\ncost effectiveness of pharmaceutical products, in addition to questioning their safety and efficacy. Adoption of price controls and cost-containment\nmeasures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of\nany product. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could\nreduce physician usage and patient demand for the product.\n\n \n\nThe\nInflation Reduction Act of 2022 (“IRA”) contains substantial drug pricing reforms, including the establishment of a drug\nprice negotiation program within the HHS that would require manufacturers to charge a negotiated “maximum fair price” for\ncertain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers of certain\ndrugs payable under Medicare Parts B and D to penalize price increases that outpace inflation, and requires manufacturers to provide\ndiscounts on Part D drugs. Substantial penalties can be assessed for noncompliance with the drug pricing provisions.\n\n \n\nDrugs\nwith an available generic or biosimilar, certain drugs that represent a limited portion of Medicare program spending, drugs with an orphan\ndesignation as their only FDA approved indication, and all plasma-derived products are exempt from direct negotiation. The number of\nnegotiated products will be phased in between 2026 and 2029, and the law sets a maximum fair price the manufacturer can charge based\non the number of years the product has been on the market. The law allows HHS to levy an excise and civil monetary penalties against\nnon-compliant manufacturers or those who refuse to negotiate.\n\n \n\n14\n\n \n\n \n\nThe\nIRA also imposes rebate requirements on manufacturers of single-source generics and other drugs covered under Medicare Part B and Part\nD where the price of the drug increases faster than inflation. Multisource generics and all products with an average manufacturer’s\nprice less than $100 per year, per individual, are exempt from rebate requirements. Beginning on October 1, 2022 for Part D products\nand on January 1, 2023 for Part B products, CMS will monitor for products with price increases higher than the rate of inflation on a\nquarterly basis. Rebates will be calculated as the total number of units sold by the amount the product exceeds the inflation-adjusted\nprice, with 2021 as the base year to measure cumulative changes relative to inflation. Noncompliant manufacturers will be subject to\na civil monetary penalty of at least 125% of the calculated rebate amount.\n\n \n\nThe\neffect of the IRA on our business, generic manufacturers, and the pharmaceutical industry in general is not yet known.\n\n \n\nWe\nexpect that additional federal, state and foreign healthcare reform measures will be adopted in the future, any of which could limit\nthe amounts that third-party payors, including government payors, will pay for healthcare products and services, which could result\nin limited coverage and reimbursement and reduced demand for our products or additional pricing pressures. On May 12, 2025,\nPresident Trump issued an executive order implementing the concept of most-favored nation (“MFN”) pricing. Under this\norder, the Department of Health and Human Services would direct federal health insurers to pay no more than the lowest price paid by\nother high-income countries for medications covered by such insurers, including Medicare and Medicaid. Under the order, MFN pricing will apply only to brand products without generic or biosimilar competition. The effect of this order on our business\nand the pharmaceutical industry in general is not yet known.\n\n \n\nAs an alternative to\nthe Affordable Care Act, President Trump announced the Great Healthcare Plan in January 2026. As presented, the plan is intended to lower\ndrug prices by increasing competition and benchmarking U.S. drug prices to other countries, reduce insurance premiums by redirecting subsidies\nfrom insurers to individuals, increase accountability and transparency from insurers, and promote consumer choice by giving individuals\nmore direct control over how healthcare dollars are spent. Legislative and regulatory action will be required to fully implement the plan.\nIt is unclear how these proposed changes will impact our business and the pharmaceutical industry in general.\n\n \n\nAt the state level,\nlegislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including\nprice or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency\nmeasures, and in some cases, designed to encourage importation from other countries and bulk purchasing. Additional reform measures may\nbe adopted in the future\n\n \n\n*Compliance\nwith Environmental Laws*\n\n \n\nWe\nare subject to comprehensive federal, state and local environmental laws and regulations that govern, among other things, air polluting\nemissions, waste water discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or\npast generation handling and disposal activities, including the past practices of corporations as to which we are the legal successor\nor in possession. We do not expect that compliance with such environmental laws will have a material effect on our capital expenditures,\nearnings, or competitive position in the foreseeable future. There can be no assurance, however, that future changes in environmental\nlaws or regulations, administrative actions or enforcement actions, or remediation obligations arising under environmental laws will\nnot have a material adverse effect on our capital expenditures, earnings, or competitive position.\n\n \n\n*Competition*\n\n \n\nThe\nCompany has competition with respect to our principal areas of operation. We develop, manufacture and distribute generic products. Elite’s\nproduct lines consist of solid oral dose products, both immediate-release and controlled-release, which are marketed under the Elite\nLabs label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. The\nprincipal competitive factors in the generic pharmaceutical market include: (i) introduction of other generic drug manufacturers’\nproducts in direct competition with our products under development, (ii) introduction of authorized generic products in direct competition\nwith any of our products under development, particularly if such products are approved and sold during exclusivity periods, (iii) consolidation\namong distribution outlets through mergers and acquisitions and the formation of buying groups, (iv) ability of generic competitors to\nquickly enter the market after the expiration of patents or exclusivity periods, diminishing the amount and duration of significant profits,\n(v) the willingness of generic drug customers, including wholesale and retail customers, to switch among pharmaceutical manufacturers,\n(vi) pricing pressures and product deletions by competitors, (vii) a company’s reputation as a manufacturer and distributor of\nquality products, (viii) a company’s level of service (including maintaining sufficient inventory levels for timely deliveries),\n(ix) product appearance and labelling and (x) a company’s breadth of product offerings.\n\n \n\n**Sources\nand Availability of Raw Materials; Manufacturing**\n\n \n\nA\nsignificant portion of our raw materials may be available only from foreign sources. Foreign sources can be subject to the special risks\nof doing business abroad, including:\n\n \n\n \n●\nGreater\npossibility for disruption due to transportation or communication problems;\n\n \n\n \n●\nThe\nrelative instability of some foreign governments and economies;\n\n \n\n \n●\nInterim\nprice volatility based on labor unrest, materials or equipment shortages, export duties, restrictions on the transfer of funds, or\nfluctuations in currency exchange rates; and\n\n \n\n \n●\nUncertainty\nregarding recourse to a dependable legal system for the enforcement of contracts and other rights.\n\n \n\nWhile\nwe currently obtain the raw materials that we need from over 20 suppliers, some materials used in our products are currently\navailable from only one supplier or a limited number of suppliers. The FDA requires identification of raw material suppliers in\napplications for approval of drug products. If raw materials were unavailable from a specified supplier, FDA approval of a new\nsupplier could delay the manufacture of the drug involved.\n\n \n\nWe\nhave acquired pharmaceutical manufacturing equipment for manufacturing our products. We have registered our facilities with the FDA and\nthe DEA.\n\n \n\n15\n\n \n\n \n\n**Our\nReporting Segments**\n\n \n\nWe\nhad previously determined that we operated in two segments, which were (i) products whose marketing approvals were secured via an ANDA\nand (ii) products whose marketing approvals were secured via an NDA. ANDA products are referred to as generic pharmaceuticals and NDA\nproducts are referred to as branded pharmaceuticals. During the year ended March 31, 2026, we determined that NDA was no longer a segment\nas the Company has paused further development of NDAs and has not engaged in business activities for several years and does not intend\nto engage in business activities related to the development of NDAs for the foreseeable future. Therefore, as of March 31, 2026, the\nCompany has determined that it operates in a single operating and reportable segment, which is ANDA. For the years ended March 31, 2026\nand 2025, revenue from our ANDA segment was $148.9 million and $84.0 million, respectively.\n\n \n\nSegment\ninformation is consistent with the financial information regularly reviewed by our chief operating decision maker, who we have determined\nto be the Chief Executive Officer, for the purpose of making decisions about allocating resources and assessing performance of the Company.\nThere are currently no intersegment revenues. Asset information by operating segment is not presented below since the CODM does not review\nthis information by segment.\n\n \n\n**Employees**\n\n \n\nAs\nof June 25, 2026, we had 65 full-time employees. Full-time employees are engaged in operations, administration, research, and development.\nNone of our employees is represented by a labor union and we have never experienced a work stoppage. We believe our relationship with\nour employees to be good. However, our ability to achieve our financial and operational objectives depends in large part upon our continuing\nability to attract, integrate, retain, and motivate highly qualified personnel, and upon the continued service of our senior management\nand key personnel."}