What changed in this filing

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Item 1. Business

2026-06-29 compared with 2025-06-30 · 332 added, 340 removed, 543 unchanged (55% of the section changed)

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high barriers to entry.

occupy manufacturing, warehouse, laboratory and office space at 135, 144 and 165 Ludlow Avenue in Northvale, NJ (the “Northvale

The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States

Drug Enforcement Agency (“DEA”) registered facility for research, development, and manufacturing.

Our website address is

www.elitepharma.com.

occupy manufacturing, warehouse, laboratory and office space at 135, 144, and 165 Ludlow Avenue in Northvale, NJ (the

“Northvale Facility”).

The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”)

and is a United States Drug Enforcement Agency (“DEA”) registered facility for research, development, and manufacturing.

Our website address is www.elitepharma.com.

focus our efforts on the following areas:

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product candidates in our pipeline including products co-developed with partners;

(iv) commercial exploitation of our product candidates

either by sales under our own label, license and the collection of royalties, or through the manufacture of our formulations;

development of new products for sale under our own label, and the expansion of our licensing agreements with other pharmaceutical companies,

including co-development projects, joint ventures and other collaborations.

(iv) commercial exploitation of our products either

by sales under our own label, license and the collection of royalties, or through the manufacture of our formulations;

and (v) development

of new products for sale under our own label, and the expansion of our licensing agreements with other pharmaceutical companies, including

co-development projects, joint ventures and other collaborations.

continue to evaluate opportunities for the development of various types of drug products, including branded drug products which require

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Act of 1984 (the “Drug Price Competition Act”) as well as generic drug products which require ANDAs.

believe that our business strategy enables us to reduce its risk by having a diverse product portfolio.

believe that our business strategy enables us to reduce our risk by having a diverse product portfolio.

own, license, manufacture, sell, distribute or receive royalties from the following products currently being sold commercially:

Branded Product Equivalent

Therapeutic Category

Phentermine HCl 37.5mg tablets (“Phentermine 37.5mg”)

Phendimetrazine Tartrate 35mg tablets (“Phendimetrazine 35mg”)

November 2012

Phentermine HCl 15mg and 30mg capsules (“Phentermine 15mg” and “Phentermine 30mg”)

Naltrexone HCl 50mg tablets (“Naltrexone 50mg”)

September 2013

Isradipine 2.5mg and 5mg capsules (“Isradipine 2.5mg” and “Isradipine 5mg”)

HCl 37.5mg tablets (“Phentermine 37.5mg”)

Phendimetrazine

Tartrate 35mg tablets (“Phendimetrazine 35mg”)

HCl 15mg and 30mg capsules (“Phentermine 15mg” and “Phentermine 30mg”)

HCl 50mg tablets (“Naltrexone 50mg”)

2.5mg and 5mg capsules (“Isradipine 2.5mg” and “Isradipine 5mg”)

Cardiovascular

Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine 100mg”)

Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine

Antidepressant

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine IR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg” and “Amphetamine IR 30mg”)

Central Nervous System (“CNS”) Stimulant

Dantrolene Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”)

Muscle Relaxant

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine ER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”)

Central Nervous System (“CNS”) Stimulant

Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”, and Loxapine 50mg”)

Dextroamphetamine

Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg,

20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine

IR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg” and “Amphetamine IR 30mg”)

Nervous System (“CNS”) Stimulant

Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”)

Dextroamphetamine

Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and

30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine

ER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”)

Nervous System (“CNS”) Stimulant

Succinate 5mg, 10mg, 25mg and 50gm capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”,

and Loxapine 50mg”)

Antipsychotic

Vigabatrin Powder 500mg (“Vigabatrin 500mg”)

Anti-epileptic

Methotrexate Sodium 2.5mg tablets (“Methotrexate 2.5mg”)

Sodium 2.5mg tablets (“Methotrexate 2.5mg”)

Antimetabolite

Acetaminophen and Codeine Phosphate 300mg/15mg, 300mg/30mg, 300mg/60mg tablets (“APAP Codeine 300mg/15mg”, “APAP Codeine 300mg/30mg”, and “APAP Codeine 300mg/60mg”)

Tylenol® with Codeine

Acetaminophen and Hydrocodone Bitartrate 325mg/2.5mg, 325mg/5mg, 325mg/7.5mg and 325mg/10mg tablets (“APAP Hydrocodone 325mg/2.5mg”, “APAP Hydrocodone 325mg/5mg”, APAP Hydrocodone 325mg/7.5mg and APAP Hydrocodone 325mg/10mg”)

December 2024

Lisdexamfetamine Dimesylate 10mg, 20mg, 30mg, 40mg, 50mg, 60mg and 70mg capsules (“Lisdex 10mg”, “Lisdex 20mg”, “Lisdex 30mg”, “Lisdex 40mg”, “Lisdex 50mg”, “Lisdex 60mg” and “Lisdex 70mg”)

December 2024

Oxycodone Hydrochloride and Acetaminophen 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets (“Oxy APAP 5/325”, “Oxy APAP 7.5/325” and “Oxy APAP 10/325”)

April 2025 (Subsequent to year-end)

Acetaminophen

and Codeine Phosphate 300mg/15mg, 300mg/30mg, 300mg/60mg tablets (“APAP Codeine 300mg/15mg”, “APAP Codeine 300mg/30mg”,

and “APAP Codeine 300mg/60mg”)

Acetaminophen

and Hydrocodone Bitartrate 325mg/2.5mg, 325mg/5mg, 325mg/7.5mg and 325mg/10mg tablets (“APAP Hydrocodone 325mg/2.5mg”,

“APAP Hydrocodone 325mg/5mg”, APAP Hydrocodone 325mg/7.5mg and APAP Hydrocodone 325mg/10mg”)

Lisdexamfetamine

Dimesylate 10mg, 20mg, 30mg, 40mg, 50mg, 60mg and 70mg capsules (“Lisdex 10mg”, “Lisdex 20mg”, “Lisdex

30mg”, “Lisdex 40mg”, “Lisdex 50mg”, “Lisdex 60mg” and “Lisdex 70mg”)

Hydrochloride and Acetaminophen 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets (“Oxy APAP 5/325”, “Oxy APAP 7.5/325”

and “Oxy APAP 10/325”)

Hydrochloride 5mg and 10mg tablets (“Methadone 5mg” and “Methadone 10mg”)

Phentermine 37.5mg is also referred to as “Phentermine Tablets”.

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to as “Oxy APAP Tablets”.

Company acquired two ANDA’s for Phentermine 37.5mg, in 2010 and 2013, respectively.

and marketing rights for Phentermine 37.5mg relating to the approved ANDA acquired in 2010 are included in the licensing agreement

between the Company and Precision Dose Inc.

(“Precision Dose”) dated September 10, 2010 (the “Precision Dose

License Agreement”).

Please see the section below titled “Precision Dose License Agreement” for further details of

this agreement.

This product is currently being manufactured by Elite and distributed by TAGI Pharma Inc.

(“TAGI”) under

the Precision Dose License Agreement.

Methadone 5mg and Methadone 10mg are collectively and individually referred to as “Methadone

Company acquired two ANDAs for Phentermine 37.5mg, in 2010 and 2013, respectively.

and marketing rights for Phentermine 37.5mg relating to the approved ANDA acquired in 2010 were licensed under an agreement between the

Company and Precision Dose Inc.

(“Precision Dose”) dated September 10, 2010 (the “Precision Dose License Agreement”)

and the Precision Dose License Agreement expired in accordance with its terms on September 10, 2025.

The Company retains all sales and marketing rights for

this product.

Phentermine 37.5mg product relating to the approved ANDA acquired in 2013 is currently a commercial product being manufactured at the

Northvale Facility and distributed by Elite Labs.

the year ended March 31, 2025, the Company withdrew the ANDA for Phentermine 37.5mg capsules from the market as it did not intend to

engage in commercial operations with this product.

As a result, the Company recognized an impairment on this product.

Phendimetrazine

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15mg and Phentermine 30mg

15mg capsules and Phentermine 30mg capsules were developed by the Company, with Elite receiving approval from the FDA of the related ANDA in September 2012.

15mg capsules and Phentermine 30mg capsules were developed by the Company, with Elite receiving approval from the FDA of the related

ANDA in September 2012.

and marketing rights for Phentermine 15mg and Phentermine 30mg are included in the Precision Dose License Agreement.

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below titled “ Precision Dose License Agreement ” for further details of this agreement.

15mg and Phentermine 30mg are currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.

The Precision Dose License

Agreement expired in accordance with its terms on September 10, 2025.

The Company retains all sales and marketing rights for this product.

15mg and Phentermine 30mg are currently commercial products being manufactured at the Northvale Facility and distributed by Elite Labs.

ANDA for Naltrexone 50mg was acquired by Elite in 2010.

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Dose License Agreement ” for further details of this agreement.

Naltrexone 50mg is currently being manufactured by Elite and

distributed by TAGI under the Precision Dose License Agreement .

The Precision Dose License Agreement expired in accordance with

its terms on September 10, 2025.

50mg is currently a commercial product being manufactured at the Northvale Facility and distributed by Elite Labs.

2.5mg and Isradipine 5mg

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IR Tablets are currently a commercial product being manufactured by Elite and distributed by Elite Labs.

October 10, 2024, the Company announced the Israeli Ministry of Health approval for Amphetamine IR Tablets.

The Company will manufacture

and supply Amphetamine IR Tablets to Dexcel Pharma (or Akiva, Israel), the Company’s exclusive distributor for the Israeli market,

under the Dexcel Pharma label.

Commercial launch of Amphetamine IR Tablets in Israel has not yet occurred.

December 6, 2021, the Company executed a license and distribution agreement with Dexcel Ltd (or Akiva, Israel) (“Dexcel”),

pursuant to which the Company manufactures and supplies Amphetamine IR Tablets to Dexcel and Dexcel is granted exclusive distribution

rights for the Israeli market for this product, under the Dexcel label (the “Dexcel Agreement”).

The first shipment

of Amphetamine IR Tablets pursuant to the Dexcel Agreement occurred in July 2025.

December 12, 2019, the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR®, an

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license agreement between the Company and Prasco dated April 5, 2023 (the “Prasco Non-Exclusive License Agreement”).

approved ANDAs for Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg (collectively, “Dantrolene Capsules”) were

acquired by Elite in 2013.

Dantrolene Capsules are a commercial product being manufactured by Elite at the Northvale Facility and

distributed by Elite Labs.

the year ended March 31, 2025, the Company recognized an impairment of the Dantrolene Capsules, as a result of reassessments of the expected

future cash flows for this product.

approved ANDAs for Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg (collectively, “Dantrolene Capsules”) were acquired

by Elite in 2013.

Dantrolene Capsules are a commercial product being manufactured by Elite at the Northvale Facility and distributed

by Elite Labs.

approved ANDA for Loxapine was acquired by Elite in 2013.

Succinate 5, 10, 25 and 50 mg are commercial products being manufactured by Elite at the Northvale Facility and distributed by Elite

June 29, 2022 the Company received approval from the FDA for Vigabatrin Powder.

The product is in the anti-epileptic therapeutic category.

Pursuant to the asset purchase agreement between the Company and Pyros Pharmaceuticals Inc.

(“Pyros”) dated November 21,

2022 (the “Pyros Asset Purchase Agreement”), the Company sold to Pyros its rights in and to the Company’s approved

ANDA for Vigabatrin Powder.

November 21, 2022, the Company entered into a Manufacturing and Supply Agreement with Pyros (the “Pyros Manufacturing and

Supply Agreement”), pursuant to which the Company manufactured and supplied to Vigabatrin Powder to Pyros at an agreed upon

This agreement was terminated upon mutual agreement as of January 10, 2025.

the year ended March 31, 2026, the Company recognized an impairment of the Loxapine Capsules, as a result of reassessments of the expected

future cash flows for this product.

May 20, 2024, the Company received approval from the FDA for Methotrexate Tablets, a product that belongs to the antimetabolite class

Methotrexate Tablets were commercially launched in August 2024 and are manufactured at the Elite Facility and distributed by

Methotrexate Tablets were commercially launched in August 2024 and are manufactured at the Northvale Facility and distributed

by Elite Labs.

Codeine Tablets

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know-how and improvements necessary or used to manufacture this product.

Codeine Tablets were commercially launched in October 2024 and are manufactured at the Elite Facility and distributed by Elite Labs.

Codeine Tablets were commercially launched in October 2024 and are manufactured at the Northvale Facility and distributed by Elite Labs.

Hydrocodone Tablets

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processes, techniques, protocols, methods, know-how and improvements necessary or used to manufacture this product.

Hydrocodone Tablets were commercially launched in December 2024 and are manufactured at the Elite Facility and distributed by Elite Labs.

Hydrocodone Tablets were commercially launched in December 2024 and are manufactured at the Northvale Facility and distributed by Elite

November 18, 2024, the Company received approval from the FDA for Lisdex Capsules, a product indicated for the treatment of Attention

Deficit Hyperactivity Disorder.

Lisdex Capsules were commercially launched in December 2024 and are manufactured at the Elite Facility

Lisdex Capsules were commercially launched in December 2024 and are manufactured at the Northvale Facility

and distributed by Elite Labs.

June 17, 2024, pursuant to the Nostrum Asset Purchase Agreement, the Company acquired all rights in and to the approved ANDA for Oxy APAP

June 17, 2024, pursuant to the Nostrum Asset Purchase Agreement, the Company acquired all rights in and to the approved ANDA for Oxy

APAP Tablets and a royalty-free, non-exclusive perpetual license to use the manufacturing technology, proprietary information, processes,

techniques, protocols, methods, know-how and improvements necessary or used to manufacture this product.

APAP Tablets were commercially launched in April 2025 and are manufactured at the Northvale Facility and distributed by Elite Labs.

June 17, 2024, pursuant to the Nostrum Asset Purchase Agreement, the Company acquired all rights in and to the approved ANDA for Methadone

Tablets and a royalty-free, non-exclusive perpetual license to use the manufacturing technology, proprietary information, processes,

techniques, protocols, methods, know-how and improvements necessary or used to manufacture this product.

APAP Tablets were commercially launched in April 2025 and are manufactured at the Elite Facility and distributed by Elite Labs.

tablets were commercially launched in April 2026 and are manufactured at the Northvale Facility and distributed by Elite Labs.

Under FDA Review

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July 15, 2016, the FDA issued a Complete Response Letter, (“CRL”), regarding the NDA.

The CRL stated that the review cycle for the SequestOx™

NDA was complete and the application is not ready for approval in its present form.

The CRL stated that the review cycle

for the SequestOx™ NDA was complete and the application is not ready for approval in its present form.

July 7, 2017, the Company reported topline results from a pivotal bioequivalence fed study for SequestOx™.

The mean Tmax (the

amount of time that a drug is present at the maximum concentration in serum) of SequestOx™ was 4.6 hr.

The mean Tmax (the amount

of 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.

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with a range of 0.5 hr.

A key objective for the

study was to determine if the reformulated SequestOx™ had a similar Tmax to the comparator when taken with a high fat meal.

on these results, the Company paused clinical trials for this formulation of SequestOx™.

On January 30, 2018, the Company reported

positive topline results from a pilot study conducted for a modified SequestOx™ wherein, based on the results of this pilot study,

the modified SequestOx™ formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference product

when conducted in a pivotal trial under fed conditions.

The Company has provided the pilot data to the FDA, requesting clarification

as to the requirements for resubmission of the NDA.

The FDA has provided guidance for repeated bio-equivalence studies in order to bridge

the new formulation to the original SequestOx™ studies.

Due to the prohibitive

cost of such repeated bio-equivalence studies and the uncertain commercial viability given the regulatory and competitive landscape,

the Company has paused development of this product candidate.

A key objective for the study was

to determine if the reformulated SequestOx™ had a similar Tmax to the comparator when taken with a high fat meal.

Based on these

results, the Company paused clinical trials for this formulation of SequestOx™.

On January 30, 2018, the Company reported positive

topline results from a pilot study conducted for a modified SequestOx™ wherein, based on the results of this pilot study, the modified

SequestOx™ formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted

in a pivotal trial under fed conditions.

The Company has provided the pilot data to the FDA, requesting clarification as to the requirements

for resubmission of the NDA.

The FDA has provided guidance for repeated bio-equivalence studies in order to bridge the new formulation

to the original SequestOx™ studies.

Due to the prohibitive cost of such repeated bio-equivalence studies and the uncertain commercial

viability given the regulatory and competitive landscape, the Company has paused development of this product candidate.

can be no assurances of the Company conducting future clinical trials, or if such trials are conducted, there can be no assurances of

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Products Filed

the Company has filed the following ANDA’s which have been accepted for review by the FDA:

dopamine agonist accepted for review in December 2022

opiate analgesic for pain management accepted for review in September 2023

the Company has filed the following ANDAs which have been accepted for review by the FDA:

A generic opiate analgesic for pain management accepted for

review in September 2023

A generic anticoagulant which was filed with the FDA in May

2026 and for which the Company is awaiting the FDA’s acceptance for review.

Products Not Yet Commercialized

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Company received approval in April 2022 from the FDA of an ANDA for a generic version of an antibiotic product, Doxycycline Hyclate Tablets.

The product is jointly

owned by Elite and Praxgen Pharmaceuticals LLC, formerly SunGen Pharma LLC, (“Praxgen”).

Hydrochloride Tablets

to the Nostrum Asset Purchase

Agreement, pursuant to which the Company acquired all rights in and to the approved ANDA for Methadone Hyrochloride Tablets and a royalty-free,

non-exclusive perpetual license to use the manufacturing technology, proprietary information, processes, techniques, protocols,

methods, know-how and improvements necessary or used to manufacture this product.

The product is jointly owned by Elite and Praxgen Pharmaceuticals LLC, formerly SunGen Pharma LLC, (“Praxgen”).

Company received approval in November 2025 for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP) (“Ropinirol

Ropinirole belongs to a class of drugs known as a non-ergoline dopamine used to treat symptoms of Parkinson’s

can be no assurances in relation to any of the above approved products not yet commercialized, that there will be future revenues of

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is made to determine the optimal course of action to achieve disposition of the ANDA.

the year ended March 31, 2025, the Company transferred the following ANDAs from the discontinued list to active:

Codeine Tablets

Hydrocodone Tablets

Hydrochloride Tablets

the year ended March 31, 2025, the Company withdrew the ANDA for Phentermine 37.5mg capsules from the market as it did not intend to

engage in commercial operations with this product and therefore recognized an impairment.

the year ended March 31, 2026, the Company moved ANDAs for Phentermine 15mg and Phentermine 30mg onto the discontinued list as it does

not intend to engage in commercial operations with these products at this time.

Elite continues to sell Phentermine 15mg and Phentermine

30mg, however, with a different ANDA that remains active.

Manufacturing and Development Agreements

Dose License Agreement

September 10, 2010, the Company executed the Precision Dose License Agreement to market and distribute Phentermine 37.5mg, Phentermine 15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional

products that require approval from the FDA, through its wholly-owned subsidiary, TAGI, in the United States, Puerto Rico and Canada.

September 10, 2010, the Company executed the Precision Dose License Agreement to market and distribute Phentermine 37.5mg, Phentermine

15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional products that require approval from the FDA, through

its wholly-owned subsidiary, TAGI, in the United States, Puerto Rico and Canada.

Phentermine 37.5mg was launched in April 2011.

Hydromorphone 8mg was launched in March 2012.

Phentermine 15mg and Phentermine 30mg were

launched in April 2013.

Hydromorphone

8mg was launched in March 2012.

Phentermine 15mg and Phentermine 30mg were launched in April 2013.

Naltrexone 50mg was launched in September

Precision Dose has the exclusive right to market these

products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada.

to the Precision Dose License Agreement, Elite will receive a license fee and milestone payments.

The license fee is computed as

a percentage of the gross profit, as defined in the Precision Dose License Agreement, earned by Precision Dose as a result of sales of

the products.

The license fee is payable monthly for the term of the Precision Dose License Agreement.

The milestone payments are to be

paid in six installments.

The first installment was paid upon execution of the Precision Dose License Agreement.

The remaining installments

are to be paid upon FDA approval and initial shipment of the products to Precision Dose.

The term of the Precision Dose License Agreement

is 15 years and may be extended for terms of 5 years each.

Precision Dose had the exclusive right to market these products in the United States and Puerto Rico and a non-exclusive right

to market the products in Canada.

to the Precision Dose License Agreement, Elite received a license fee and milestone payments.

The license fee was computed as a percentage

of the gross profit, as defined in the Precision Dose License Agreement, earned by Precision Dose as a result of sales of the products.

The license fee was payable monthly for the term of the Precision Dose License Agreement.

The milestone payments consisted of payments

due upon execution of the Precision Dose License Agreement and upon FDA approval and initial shipments of products to Precision Dose.

Precision Dose License Agreement had an initial term of 15 years and expired in accordance with its terms, on September

Non-Exclusive License Agreement

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The Pyros Agreement was terminated by mutual agreement on January 10, 2025.

Dexcel Agreement for Israel

December 6, 2021, the Company entered into the Dexcel Agreement for Amphetamine IR 10mg, Amphetamine IR 20mg and Amphetamine

Pursuant to the Dexcel Agreement, Elite manufactures and packages the product under Dexcel’s label.

Dexcel provides

sales, marketing and distribution.

Dexcel pays an agreed upon transfer price for the product and shares any profits when the net selling

price exceeds a floor price, as defined in the Dexcel Agreement.

The first shipment of product under this agreement was made in July

Under Development

research and development activities include developing its proprietary abuse-deterrent technology and the development of a range of abuse-deterrent opioid products that utilize this technology or other approaches to abuse deterrence.

research and development activities include developing its proprietary abuse-deterrent technology and the development of a range of abuse-deterrent

opioid products that utilize this technology or other approaches to abuse deterrence.

proprietary abuse-deterrent technology utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate

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Both, agonist, and antagonist, have been on the market for a number of years and sold separately in various dose strengths.

Company is currently not selling abuse-deterrent and sustained release opioids and is evaluating the market place when deciding to

proceed with the above listed filed applications.

Company is currently not selling abuse-deterrent and sustained release opioids and is evaluating the market place when deciding to proceed

with the above listed filed applications.

Company owns the following patents (as of March 31, 2026):

EXPIRATION DATE

patent 9,056,054

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such patents and compete with us using the resulting alternative technology.

During the year ended

March 31, 2026, a patent related to the Company’s abuse deterrent opioid technology expired before marketing authorization was obtained

from the FDA, and therefore all capitalized costs related to the application of this patent were impaired in full during the year ended

March 31, 2026.

Refer to Note 4 of our consolidated financial statements for additional information.

is a trademark owned by Elite.

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limited circumstances.

FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its

manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality, and purity.

Prescription Drug User Fee Act (“PDUFA”) guidelines that are currently in effect, the FDA has a goal of ten months from the

date of “filing” of a standard NDA for a new molecular entity to review and act on the submission.

This review typically

takes 12 months from the date the NDA is submitted to FDA because the FDA has approximately two months to make a

“filing” decision after the application is submitted.

The FDA conducts a preliminary review of all NDAs within the first

60 days after submission, before accepting them for filing, to determine whether they are sufficiently complete to permit

substantive review The FDA may request additional information rather than accept an NDA for filing.

In this event, the NDA must be

resubmitted with the additional information.

The resubmitted application is also subject to review before the FDA accepts it for

FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing

is cGMP-compliant to assure and preserve the product’s identity, strength, quality, and purity.

Under the Prescription Drug User

Fee Act (“PDUFA”) guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing”

of a standard NDA for a new molecular entity to review and act on the submission.

This review typically takes 12 months from the date

the NDA is submitted to FDA because the FDA has approximately two months to make a “filing” decision after the application

is submitted.

The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for

filing, to determine whether they are sufficiently complete to permit substantive review The FDA may request additional information rather

than accept an NDA for filing.

In this event, the NDA must be resubmitted with the additional information.

The resubmitted application

is also subject to review before the FDA accepts it for filing.

FDA may refer an application for a novel drug to an advisory committee.

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approving an NDA, the FDA will typically inspect the facility or facilities where the product is manufactured.

The FDA will not

approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP and adequate

to assure consistent production of the product within required specifications.

Additionally, before approving an NDA, the FDA will

typically inspect one or more clinical sites to assure compliance with good clinical practices (“GCPs”).

If the FDA determines that the

application, manufacturing process, or manufacturing facilities are not acceptable, it will outline the deficiencies in the

submission and often will request additional testing or information.

Notwithstanding the submission of any requested additional

information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

The FDA will not approve

an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP and adequate to assure

consistent production of the product within required specifications.

Additionally, before approving an NDA, the FDA will typically inspect

one or more clinical sites to assure compliance with good clinical practices (“GCPs”).

If the FDA determines that the application,

manufacturing process, or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will

request additional testing or information.

Notwithstanding the submission of any requested additional information, the FDA ultimately

may decide that the application does not satisfy the regulatory criteria for approval.

the FDA evaluates an NDA, it will issue an approval letter or a CRL.

An approval letter authorizes commercial marketing

of the drug with prescribing information for specific indications.

A Complete Response Letter indicates that the review cycle of the

application is complete, and the application will not be approved in its present form.

A Complete Response Letter usually describes the

specific deficiencies in the NDA identified by the FDA and may require additional clinical data, such as an additional pivotal Phase

3 clinical trial or other significant and time-consuming requirements related to clinical trials, nonclinical studies, or manufacturing.

If a Complete Response Letter is issued, the sponsor must resubmit the NDA, addressing all of the deficiencies identified in the letter,

or withdraw the application.

Even if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria

for approval.

An approval letter authorizes commercial marketing of the drug with

prescribing information for specific indications.

A Complete Response Letter indicates that the review cycle of the application is complete,

and the application will not be approved in its present form.

A Complete Response Letter usually describes the specific deficiencies

in the NDA identified by the FDA and may require additional clinical data, such as an additional pivotal Phase 3 clinical trial or other

significant and time-consuming requirements related to clinical trials, nonclinical studies, or manufacturing.

If a Complete Response

Letter is issued, the sponsor must resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application.

Even if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval.

regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the

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Strategy (“REMS”) to ensure the benefits of the product outweigh its risks.

A REMS is a safety strategy to manage a known or potential

serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.

It could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods,

patient registries, and other risk minimization tools.

The FDA also may offer conditional approval subject to, among other things, changes

to proposed labeling or the development of adequate controls and specifications.

Once approved, the FDA may withdraw the product approval

if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace.

The FDA may also require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety

and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing

A REMS is a safety strategy to manage a known

or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their

It could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution

methods, patient registries, and other risk minimization tools.

The FDA also may offer conditional approval subject to, among other things,

changes to proposed labeling or the development of adequate controls and specifications.

Once approved, the FDA may withdraw the product

approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the

The FDA may also require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s

safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing

In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s

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the referenced product have expired;

until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity (“NCE”), listed in

its publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” also referred to as the “Orange

Book”, for the referenced product has expired;

and, in the case of a Paragraph IV certification and subsequent patent infringement

suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case that is favorable to the Section

505(b)(2) applicant.

until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity

(“NCE”), listed in its publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” also referred

to as the “Orange Book”, for the referenced product has expired;

and, in the case of a Paragraph IV certification and subsequent

patent infringement suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case that is favorable

to the Section 505(b)(2) applicant.

In the interim period, the FDA may grant tentative approval.

Tentative approval indicates that the FDA has determined

that the applicant meets the standards for approval as of the date that the tentative approval is granted.

Final regulatory approval

can only be granted if the FDA is assured that there is no new information that would affect final regulatory/ approval.

Tentative approval indicates that the

FDA has determined that the applicant meets the standards for approval as of the date that the tentative approval is granted.

Final regulatory

approval can only be granted if the FDA is assured that there is no new information that would affect final regulatory/ approval.

obtain approval of a generic drug, an applicant must submit an ANDA, to the FDA.

comprehensive submission that contains, among other things, data and information pertaining to the active pharmaceutical ingredient,

bioequivalence, drug product formulation, specifications and stability of the generic drug, as well as analytical methods, manufacturing

process validation data and quality control procedures.

ANDAs are “abbreviated” because they cannot include preclinical and

clinical data to demonstrate safety and effectiveness.

Instead, in support of such applications, a generic manufacturer must rely on

the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference

listed drug (“RLD”).

order 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, route of administration, dosage form, strength of the drug and conditions of use of the drug.

At the same time, the FDA

must also determine that the generic drug is “bioequivalent” to the innovator drug.

Under the statute, a generic drug is

bioequivalent to a RLD if “the rate and extent of absorption of the drug do not show a significant difference from the rate and

extent of absorption of the listed drug.” Upon approval of an ANDA, the FDA indicates whether the generic product is “therapeutically

equivalent” to the RLD in the Orange Book.

Physicians and pharmacists consider a therapeutic equivalent generic drug to be fully

substitutable for the RLD.

In addition, by operation of certain state laws and numerous health insurance programs, the FDA’s designation

of therapeutic equivalence often results in substitution of the generic drug without the knowledge or consent of either the prescribing

physician or patient.

an ANDA applicant submits its application, it is required to certify to the FDA concerning any patents listed for the reference

product in the Orange Book.

An ANDA is a comprehensive submission that contains,

among other things, data and information pertaining to the active pharmaceutical ingredient, bioequivalence, drug product formulation,

specifications and stability of the generic drug, as well as analytical methods, manufacturing process validation data and quality control

ANDAs are “abbreviated” because they cannot include preclinical and clinical data to demonstrate safety and effectiveness.

Instead, in support of such applications, a generic manufacturer must rely on the preclinical and clinical testing previously conducted

for a drug product previously approved under an NDA, known as the reference listed drug (“RLD”).

order 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,

route of administration, dosage form, strength of the drug and conditions of use of the drug.

At the same time, the FDA must also determine

that the generic drug is “bioequivalent” to the innovator drug.

Under the statute, a generic drug is bioequivalent to a RLD

if “the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of

the listed drug.” Upon approval of an ANDA, the FDA indicates whether the generic product is “therapeutically equivalent”

to the RLD in the Orange Book.

Physicians and pharmacists consider a therapeutic equivalent generic drug to be fully substitutable for

In addition, by operation of certain state laws and numerous health insurance programs, the FDA’s designation of therapeutic

equivalence often results in substitution of the generic drug without the knowledge or consent of either the prescribing physician or

an ANDA applicant submits its application, it is required to certify to the FDA concerning any patents listed for the reference product

in the Orange Book.

Specifically, the ANDA applicant must certify that:

(i) the required patent information has not

(ii) the listed patent has expired;

(iii) the listed patent has not expired, but will expire on a particular date and approval

is sought after patent expiration;

(i) the required patent information has not been filed;

the listed patent has expired;

(iii) the listed patent has not expired, but will expire on a particular date and approval is sought after

patent expiration;

or (iv) the listed patent is invalid or will not be infringed by the new product.

the follow-on applicant does not challenge the innovator’s listed patents, FDA will not approve the ANDA until all

the listed patents claiming the referenced product have expired.

A certification that the new product will not infringe the already approved

product’s listed patents, or that such patents are invalid, is called a Paragraph IV certification.

If the follow-on applicant

has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA

and patent holders once the ANDA has been accepted for filing by the FDA.

The NDA and patent holders may then initiate a patent infringement

lawsuit in response to the notice of the Paragraph IV certification.

The filing of a patent infringement lawsuit within 45 days of the

receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration

of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant.

the follow-on applicant does not challenge the innovator’s listed patents, FDA will not approve the ANDA until all the listed patents

claiming the referenced product have expired.

A certification that the new product will not infringe the already approved product’s

listed patents, or that such patents are invalid, is called a Paragraph IV certification.

If the follow-on applicant has provided a Paragraph

IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once

the ANDA has been accepted for filing by the FDA.

The NDA and patent holders may then initiate a patent infringement lawsuit in response

to the notice of the Paragraph IV certification.

The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph

IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration of the patent, settlement

of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant.

May 1992, Congress enacted the Generic Drug Enforcement Act of 1992, which allows the FDA to impose debarment and other penalties on

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We do not believe that we receive any services from any debarred

federal Controlled Substances Act of 1970 (“CSA”) and its implementing regulations establish a “closed system” of

regulations for controlled substances.

federal Controlled Substances Act of 1970 (“CSA”) and its implementing regulations establish a “closed system”

of regulations for controlled substances.

The CSA imposes registration, security, recordkeeping and reporting, storage, manufacturing,

distribution, importation, exportation, disposal and other requirements under the oversight of the DEA.

The DEA is the federal agency responsible for regulating controlled substances, and requires those individuals or entities that

manufacture, import, export, distribute, research, or dispense controlled substances to comply with the regulatory requirements in

order to prevent the diversion of controlled substances to illicit channels of commerce.

The DEA is the federal agency

responsible for regulating controlled substances, and requires those individuals or entities that manufacture, import, export, distribute,

research, or dispense controlled substances to comply with the regulatory requirements in order to prevent the diversion of controlled

substances to illicit channels of commerce.

DEA categorizes controlled substances into one of five schedules — Schedule I, II, III, IV or V — with

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of controlled substances.

drugs manufactured in the United States, the DEA annually establishes an aggregate quota for the amount of substances

within Schedules I 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 medical, scientific, research and industrial needs.

The quotas apply equally to the manufacturing

of the active pharmaceutical ingredient and production of dosage forms.

The DEA may adjust aggregate production quotas, and

individual manufacturing or procurement quotas from time to time, although the DEA has substantial discretion in whether or not to

make such adjustments for individual companies.

The DEA quota system was amended in 2018 to require sponsors to strengthen controls

over diversion of controlled substances, controls and limits the availability and production of controlled substances in Schedule I

drugs manufactured in the United States, the DEA annually establishes an aggregate quota for the amount of substances within Schedules

I 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

medical, scientific, research and industrial needs.

The quotas apply equally to the manufacturing of the active pharmaceutical ingredient

and production of dosage forms.

The DEA may adjust aggregate production quotas, and individual manufacturing or procurement quotas from

time to time, although the DEA has substantial discretion in whether or not to make such adjustments for individual companies.

quota system was amended in 2018 to require sponsors to strengthen controls over diversion of controlled substances, controls and limits

the availability and production of controlled substances in Schedule I or II.

laws have been enacted to address the national epidemics of prescription opioid abuse and illicit opioid use.

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was signed into law in November 2018, includes a number of measures directed towards regulation and improvement of treatment for substance

use-disorder and increased coverage by Centers for Medicare and Medicaid Services (“CMS”) of medically-assisted treatment options.

In addition, the SUPPORT Act requires HHS to report

to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries

use-disorder and increased coverage by Centers for Medicare and Medicaid Services (“CMS”) of medically-assisted treatment

In addition, the SUPPORT Act requires HHS to report to Congress on existing barriers to access to abuse-deterrent opioid formulations

by Medicare Part C and D beneficiaries

states also maintain separate controlled substance laws and regulations, including licensing, recordkeeping, security, distribution,

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Corrupt Practices Act

Foreign Corrupt Practices Act (“FCPA”), generally prohibits offering, promising, giving, or authorizing others to give anything of

value, either directly or indirectly, to a non-U.S.

government official in order to influence official action, or otherwise obtain or

retain business.

The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions

of the corporation and to devise and maintain an adequate system of internal accounting controls.

Our industry is heavily regulated and

therefore involves significant interaction with public officials, including officials of non-U.S.

Additionally, in many

other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals

are government entities;

therefore, our dealings with these prescribers and purchasers are subject to regulation under the FCPA.

the SEC and DOJ have increased their FCPA enforcement activities with respect to pharmaceutical companies.

Foreign Corrupt Practices Act (“FCPA”), generally prohibits offering, promising, giving, or authorizing others to give anything

of value, either directly or indirectly, to a non-U.S.

government official in order to influence official action, or otherwise obtain

or retain business.

The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the

transactions of the corporation and to devise and maintain an adequate system of internal accounting controls.

Our industry is heavily

regulated and therefore involves significant interaction with public officials, including officials of non-U.S.

Additionally,

in many other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers

of pharmaceuticals are government entities;

therefore, our dealings with these prescribers and purchasers are subject to regulation under

Recently, the SEC and DOJ have increased their FCPA enforcement activities with respect to pharmaceutical companies.

could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of our facilities, requirements

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on the conduct of our business.

Enforcement actions may be brought by the DOJ or the SEC, and legislation has expanded the SEC’s power to seek disgorgement in all FCPA cases filed in

federal court and extended the statute of limitations in SEC enforcement actions in intent-based claims such as those under the FCPA

from five years to ten years.

Enforcement actions may be brought by the DOJ or the SEC, and legislation has expanded the SEC’s

power to seek disgorgement in all FCPA cases filed in federal court and extended the statute of limitations in SEC enforcement actions

in intent-based claims such as those under the FCPA from five years to ten years.

and Reimbursement

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Inflation Reduction Act of 2022 (“IRA”) contains substantial drug pricing reforms, including the establishment of a drug

price negotiation program within the HHS that would require manufacturers to charge a negotiated

“maximum fair price” for certain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment

requirements on manufacturers of certain drugs payable under Medicare Parts B and D to penalize price increases that outpace inflation,

and requires manufacturers to provide discounts on Part D drugs.

Substantial penalties can be assessed for noncompliance with the drug

pricing provisions.

price negotiation program within the HHS that would require manufacturers to charge a negotiated “maximum fair price” for

certain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers of certain

drugs payable under Medicare Parts B and D to penalize price increases that outpace inflation, and requires manufacturers to provide

discounts on Part D drugs.

Substantial penalties can be assessed for noncompliance with the drug pricing provisions.

with an available generic or biosimilar, certain drugs that represent a limited portion of Medicare program spending, drugs with an orphan

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a civil monetary penalty of at least 125% of the calculated rebate amount.

effect of the IRA on our business, generic manufacturers, and the pharmaceutical industry in general is not

effect of the IRA on our business, generic manufacturers, and the pharmaceutical industry in general is not yet known.

expect that additional federal, state and foreign healthcare reform measures will be adopted in the future, any of which could limit

the amounts that third-party payors, including government payors, will pay for healthcare products and services, which could result in

limited coverage and reimbursement and reduced demand for our products or additional pricing pressures.

On May 12, 2025, President Trump issued an executive order implementing the concept of most-favored nation pricing.

Under this order, the Department of Health and Human Services would direct federal health insurers to pay no more than the lowest price

paid by other high-income countries for medications covered by such insurers, including Medicare and Medicaid.

Under the order, most-favored

nation pricing will apply only to brand products without generic or biosimilar competition.

The effect of this order on our business and

the pharmaceutical industry in general is not yet known.

the amounts that third-party payors, including government payors, will pay for healthcare products and services, which could result

in limited coverage and reimbursement and reduced demand for our products or additional pricing pressures.

On May 12, 2025,

President Trump issued an executive order implementing the concept of most-favored nation (“MFN”) pricing.

order, the Department of Health and Human Services would direct federal health insurers to pay no more than the lowest price paid by

other 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

and the pharmaceutical industry in general is not yet known.

As an alternative to

the Affordable Care Act, President Trump announced the Great Healthcare Plan in January 2026.

As presented, the plan is intended to lower

drug prices by increasing competition and benchmarking U.S.

drug prices to other countries, reduce insurance premiums by redirecting subsidies

from insurers to individuals, increase accountability and transparency from insurers, and promote consumer choice by giving individuals

more direct control over how healthcare dollars are spent.

Legislative and regulatory action will be required to fully implement the plan.

It is unclear how these proposed changes will impact our business and the pharmaceutical industry in general.

At the state level,

legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including

price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency

measures, and in some cases, designed to encourage importation from other countries and bulk purchasing.

Additional reform measures may

be adopted in the future

with Environmental Laws

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not have a material adverse effect on our capital expenditures, earnings, or competitive position.

have competition with respect to our principal areas of operation.

We develop and manufacture generic products, products using controlled-release

drug technology, products utilizing abuse-deterrent technologies, and we develop and market (either on our own or by license to other

companies) generic and proprietary controlled-release and abuse-deterrent pharmaceutical products.

In both areas, our competition consists

of those companies which develop controlled release, abuse-deterrent drugs and alternative drug delivery systems.

We do not represent

a significant presence in the pharmaceutical industry.

increasing number of pharmaceutical companies have become interested in the development and commercialization of products

incorporating advanced or novel drug delivery systems.

Some of the major pharmaceutical companies have invested and are continuing

to invest significant resources in the development of their own drug delivery systems and technologies and some have invested funds

in such specialized drug delivery companies.

Many of these companies have greater financial and other resources as well as more

experience than we do in commercializing pharmaceutical products.

Certain companies have a track record of success in developing

controlled-release drugs.

Significant among these are, without limitation, Pfizer, Sandoz (a Novartis company), Mylan Laboratories,

Inc., Endo Pharmaceuticals, Inc., Teva Pharmaceuticals Industries Ltd., Amneal Laboratories, Inc., Mallinckrodt Pharmaceuticals plc,

and Aurobindo Pharma USA, Inc.

Each of these companies has developed expertise in certain types of drug delivery systems, although such expertise

does not carry over to developing a controlled-release version of all drugs.

Such companies may develop new drug formulations and

products or may improve existing drug formulations and products more efficiently than we can.

In addition, almost all of our

competitors have vastly greater resources than we do.

While our product development capabilities and, if obtained, patent protection

may help us to maintain our market position in the field of advanced drug delivery, there can be no assurances that others will not

be able to develop such capabilities or alternative technologies outside the scope of our patents, if any, or that even if patent

protection is obtained, such patents will not be successfully challenged in the future.

addition to competitors that are developing products based on drug delivery technologies, there are also companies that have announced

that they are developing opioid abuse-deterrent products that might compete directly or indirectly with Elite’s products.

include, but are not limited to Pfizer Inc., Collegium Pharmaceuticals, Inc., and Purdue Pharma LP.

also face competition in the generic pharmaceutical market.

The principal competitive factors in the generic pharmaceutical market include:

(i) introduction of other generic drug manufacturers’ products in direct competition with our products under development, (ii)

introduction of authorized generic products in direct competition with any of our products under development, particularly if such products

are approved and sold during exclusivity periods, (iii) consolidation among distribution outlets through mergers and acquisitions and

the formation of buying groups, (iv) ability of generic competitors to quickly enter the market after the expiration of patents or exclusivity

periods, diminishing the amount and duration of significant profits, (v) the willingness of generic drug customers, including wholesale

and retail customers, to switch among pharmaceutical manufacturers, (vi) pricing pressures and product deletions by competitors, (vii)

a company’s reputation as a manufacturer and distributor of quality products, (viii) a company’s level of service (including

maintaining sufficient inventory levels for timely deliveries), (ix) product appearance and labelling and (x) a company’s breadth

of product offerings.

Company has competition with respect to our principal areas of operation.

We develop, manufacture and distribute generic products.

product lines consist of solid oral dose products, both immediate-release and controlled-release, which are marketed under the Elite

Labs label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations.

principal competitive factors in the generic pharmaceutical market include:

(i) introduction of other generic drug manufacturers’

products in direct competition with our products under development, (ii) introduction of authorized generic products in direct competition

with any of our products under development, particularly if such products are approved and sold during exclusivity periods, (iii) consolidation

among distribution outlets through mergers and acquisitions and the formation of buying groups, (iv) ability of generic competitors to

quickly enter the market after the expiration of patents or exclusivity periods, diminishing the amount and duration of significant profits,

(v) the willingness of generic drug customers, including wholesale and retail customers, to switch among pharmaceutical manufacturers,

(vi) pricing pressures and product deletions by competitors, (vii) a company’s reputation as a manufacturer and distributor of

quality products, (viii) a company’s level of service (including maintaining sufficient inventory levels for timely deliveries),

(ix) product appearance and labelling and (x) a company’s breadth of product offerings.

and Availability of Raw Materials;

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regarding recourse to a dependable legal system for the enforcement of contracts and other rights.

we currently obtain the raw materials that we need from over 20 suppliers, some materials used in our products are currently available

from only one supplier or a limited number of suppliers.

The FDA requires identification of raw material suppliers in applications for

approval of drug products.

If raw materials were unavailable from a specified supplier, FDA approval of a new supplier could delay the

manufacture of the drug involved.

we currently obtain the raw materials that we need from over 20 suppliers, some materials used in our products are currently

available from only one supplier or a limited number of suppliers.

The FDA requires identification of raw material suppliers in

applications for approval of drug products.

If raw materials were unavailable from a specified supplier, FDA approval of a new

supplier could delay the manufacture of the drug involved.

have acquired pharmaceutical manufacturing equipment for manufacturing our products.

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Reporting Segments

currently operate in two segments, which are (i) products whose marketing approvals were secured via an ANDA and (ii) products whose

marketing approvals were secured via an NDA.

ANDA products are referred to as generic pharmaceuticals and NDA products are referred

to as branded pharmaceuticals.

For the years ended March 31, 2025 and 2024 revenue from our ANDA segment were $84.0 million and

$56.6 million, respectively.

For the years ended March 31, 2025 and 2024 revenue from our NDA segment were $0.0 million and $0.0

million, respectively.

had previously determined that we operated in two segments, which were (i) products whose marketing approvals were secured via an ANDA

and (ii) products whose marketing approvals were secured via an NDA.

ANDA products are referred to as generic pharmaceuticals and NDA

products are referred to as branded pharmaceuticals.

During the year ended March 31, 2026, we determined that NDA was no longer a segment

as the Company has paused further development of NDAs and has not engaged in business activities for several years and does not intend

to engage in business activities related to the development of NDAs for the foreseeable future.

Therefore, as of March 31, 2026, the

Company has determined that it operates in a single operating and reportable segment, which is ANDA.

For the years ended March 31, 2026

and 2025, revenue from our ANDA segment was $148.9 million and $84.0 million, respectively.

information is consistent with the financial information regularly reviewed by our chief operating decision maker, who we have determined

to be the Chief Executive Officer, for the purposes of making decisions about allocating resources and assessing performance of the Company.

to be the Chief Executive Officer, for the purpose of making decisions about allocating resources and assessing performance of the Company.

There are currently no intersegment revenues.

Asset information by operating segment is not presented below since the CODM does not review this information by segment.

Asset information by operating segment is not presented below since the CODM does not review

this information by segment.

of June 25, 2026, we had 65 full-time employees.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business