OTC: ELTP

We
continue to evaluate opportunities for the development of various types of drug products, including branded drug products which require
New Drug Applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration
Act of 1984 (the “Drug Price Competition Act”) as well as generic drug products which require ANDAs.

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

1

Commercial
Products

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

Product

Branded

Product
Equivalent

Therapeutic

Category

Launch
Date

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

Adipex-P®

Bariatric

April
2011

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

Bontril®

Bariatric

November
2012

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

Adipex-P®

Bariatric

April
2013

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

Revia®

Pain

September
2013

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

N/A

Cardiovascular

January
2015

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

Surmontil®

Antidepressant

May
2017

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”)

Adderall®

Central
Nervous System (“CNS”) Stimulant

April
2019

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

Dantrium®

Muscle
Relaxant

June
2019

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”)

Adderall
XR®

Central
Nervous System (“CNS”) Stimulant

March
2020

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

Loxapine®

Antipsychotic

May
2021

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

Otrexup
PF®

Antimetabolite

August
2024

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

Pain

October
2024

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”)

Norco®

Pain

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”)

Vyvanse®

ADHD

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”)

Percocet®

Pain

April
2025

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

Dolophine®

Pain

April
2026

Note:
Phentermine 37.5mg is also referred to as “Phentermine Tablets”. Phentermine 15mg and Phentermine 30mg are collectively and
individually referred to as “Phentermine Capsules”. Phendimetrazine 35mg is also referred to as “Phendimetrazine Tablets”.
Naltrexone 50mg is also referred to as “Naltrexone Tablets”. Isradipine 2.5mg and Isradipine 5mg are collectively and individually
referred to as “Isradipine Capsules”. Trimipramine 25mg, Trimipramine 50mg, and Trimipramine 100mg are collectively and individually
referred to as “Trimipramine Capsules”. Amphetamine IR 5mg, Amphetamine IR 7.5mg, Amphetamine IR 10mg, Amphetamine IR 12.5mg,
Amphetamine IR 15mg, Amphetamine IR 20mg and Amphetamine IR 30mg are collectively and individually referred to as “Amphetamine
IR Tablets”. Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg are collectively and individually referred to as “Dantrolene
Capsules”. Amphetamine ER 5mg, Amphetamine ER 10mg, Amphetamine ER 15mg. Amphetamine ER 20mg, Amphetamine ER 25mg and Amphetamine
ER 30mg are collectively and individually referred to as “Amphetamine ER Capsules”. Loxapine 5gm, Loxapine 10mg, and Loxapine
25mg, Loxapine 50mg are collectively and individually referred to as “Loxapine Capsules”, Vigabatrin 500mg is collectively
and individually referred to as “Vigabatrin Powder”, Methotrexate 2.5mg” is collectively and individually referred
to as “Methotrexate Tablets”, APAP Codeine 300mg/15mg, APAP Codeine 300mg/30mg, and APAP Codeine 300mg/60mg are collectively
and individually referred to as “APAP Codeine Tablets, APAP Hydrocodone 325mg/2.5mg, APAP Hydrocodone 325mg/5mg, APAP Hydrocodone
325mg/7.5mg and APAP Hydrocodone 325mg/10mg are collectively and individually referred to as “APAP Hydrocodone Tablets”,
Lisdex 10mg, Lisdex 20mg, Lisdex 30mg, Lisdex 40mg, Lisdex 50mg, Lisdex 60mg and Lisdex 70mg are collectively and individually referred
to as “Lisdex Capsules” and Oxy APAP 5/325, Oxy APAP 7.5/325 and Oxy APAP 10/325 are collectively and individually referred
to as “Oxy APAP Tablets”. Methadone 5mg and Methadone 10mg are collectively and individually referred to as “Methadone
Tablets” .

2

Phentermine
37.5mg

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

Sales
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.

The
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.

Phendimetrazine
Tartrate 35mg

The
ANDA for Phendimetrazine was acquired by Elite in 2013.

Phendimetrazine
35mg is currently a commercial product being manufactured at the Northvale Facility and distributed by Elite Labs.

Phentermine
15mg and Phentermine 30mg

Phentermine
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.

Sales
and marketing rights for Phentermine 15mg and Phentermine 30mg are included in the Precision Dose License Agreement. Please see the section
below titled “Precision Dose License Agreement” for further details of this 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.

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

Naltrexone
50mg

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

Sales
and marketing rights for Naltrexone 50mg are included in the Precision Dose License Agreement. Please see the section below titled “Precision
Dose License Agreement” for further details of this agreement. The Precision Dose License Agreement expired in accordance with
its terms on September 10, 2025.

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

Isradipine
2.5mg and Isradipine 5mg

The
approved ANDAs for Isradipine 2.5mg and Isradipine 5mg were acquired by Elite in 2013

Isradipine
2.5mg and Isradipine 5mg are commercial products being manufactured by Elite at the Northvale Facility and distributed by Elite Labs.

3

Trimipramine
25mg, Trimipramine 50mg and Trimipramine 100mg

The
approved ANDA for Trimipramine was acquired by Elite in 2017.

Trimipramine
25mg, Trimipramine 50mg and Trimipramine 100mg are a commercial product being manufactured by Elite at the Northvale Facility and distributed
by Elite Labs.

Amphetamine
IR Tablets

On
December 10, 2018, the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall®, an immediate-release
mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine
Sulfate) 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
and indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

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

On
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.

Amphetamine
ER Capsules

On
December 12, 2019, the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR®, an
extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate, Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg, and 30 mg tablets. The product is a central nervous system
stimulant and is indicated for the treatment of ADHD and Narcolepsy.

Amphetamine
ER Capsules are currently a commercial product being manufactured by Elite at the Northvale Facility and distributed by Elite Labs as
well as being manufactured by Elite at the Northvale Facility and distributed by Prasco, LLC (“Prasco”) pursuant to the non-exclusive
license agreement between the Company and Prasco dated April 5, 2023 (the “Prasco Non-Exclusive License Agreement”).

Dantrolene
Capsules

The
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.

Loxapine
Capsules

The
approved ANDA for Loxapine was acquired by Elite in 2013.

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

During
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.

Methotrexate
Tablets

On
May 20, 2024, the Company received approval from the FDA for Methotrexate Tablets, a product that belongs to the antimetabolite class
of drugs. Methotrexate Tablets were commercially launched in August 2024 and are manufactured at the Northvale Facility and distributed
by Elite Labs.

APAP
Codeine Tablets

On
June 17, 2024, the Company entered into an asset purchase agreement with Nostrum Laboratories Inc. (the “Nostrum Asset Purchase
Agreement”), pursuant to which the Company acquired all rights in and to the approved ANDA for APAP Codeine 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
Codeine Tablets were commercially launched in October 2024 and are manufactured at the Northvale Facility and distributed by Elite Labs.

4

APAP
Hydrocodone Tablets

On
June 17, 2024, pursuant to the Nostrum Asset Purchase Agreement, the Company acquired all rights in and to the approved ANDA to APAP
Hydrocodone 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
Hydrocodone Tablets were commercially launched in December 2024 and are manufactured at the Northvale Facility and distributed by Elite
Labs.

Lisdex
Capsules

On
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 Northvale Facility
and distributed by Elite Labs.

Oxy
APAP Tablets

On
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.

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

Methadone
Tablets

On
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.

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

Products
Under FDA Review

SequestOx™
- Immediate Release Oxycodone with sequestered Naltrexone

SequestOx™
is our abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. SequestOx™
is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5mg, 10mg, 15mg, 20mg and 30mg doses
of oxycodone into capsules.

In
January 2016, the Company submitted a 505(b)(2) New Drug Application for SequestOx™, after receiving a waiver of the $2.3 million
filing fee from the FDA. In March 2016, the Company received notification of the FDA’s acceptance of this filing and that such
filing has been granted priority review by the FDA with a target action under the Prescription Drug User Fee Act (“PDUFA”)
of July 14, 2016.

On
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.

On
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. with a range of 0.5 hr. to 12 hr.
and 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
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.

5

There
can be no assurances of the Company conducting future clinical trials, or if such trials are conducted, there can be no assurances of
the success of any future clinical trials, or if such trials are successful, there can be no assurances that an intended future resubmission
of the NDA product filing, if made, will be accepted by or receive marketing approval from the FDA. In addition, even if marketing authorization
is received, there can be no assurances that there will be future revenues or profits, or that any such future revenues or profits would
be in amounts that provide adequate return on the significant investments made to secure this marketing authorization.

Generic
Products Filed

Currently
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.

Approved
Products Not Yet Commercialized

Doxycycline
Hyclate Tablets

The
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”).

Ropinirole
ER

The
Company received approval in November 2025 for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP) (“Ropinirol
Tablets”). Ropinirole belongs to a class of drugs known as a non-ergoline dopamine used to treat symptoms of Parkinson’s
disease.

There
can be no assurances in relation to any of the above approved products not yet commercialized, that there will be future revenues of
profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments
made to secure these marketing authorizations.

Discontinued
and Transferred Products

As
part of standard operating practices, the Company, from time to time, as relevant, conducts evaluations of all ANDAs owned, consisting,
without limitation, of ANDAs acquired or approved prior to the fiscal year ended March 31, 2026 (“Fiscal 2026”) and ANDAs
acquired or approved during the Fiscal 2026. Such evaluations include, without limitation, costs and benefits relating to each ANDA owned,
with such costs including those fees required under the FDA’s Generic Drug User Fee Amendment which is significantly influenced
by the number of ANDAs owned, and other costs and benefits taking into consideration various specific market factors for each ANDA. Those
ANDAs with a cost/benefit profile not consistent with management criteria for continuation are identified for disposition and effort
is made to determine the optimal course of action to achieve disposition of the ANDA.

During
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.

6

Licensing,
Manufacturing and Development Agreements

Precision
Dose License Agreement

On
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. Naltrexone 50mg was launched in September
2013. 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.

Pursuant
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.

The
Precision Dose License Agreement had an initial term of 15 years and expired in accordance with its terms, on September
10, 2025.

Prasco
Non-Exclusive License Agreement

On
April 5, 2023, the Company entered into a non-exclusive license agreement to manufacture, supply and distribute with Prasco, LLC and
its affiliate Burel to distribute generic mixed amphetamine extended-release capsules in the United States. The agreement commenced on
January 1, 2024 and was terminated with notice on March 31, 2025.

Pyros
Manufacturing and Supply Agreement

In
conjunction with the sale of its Product to Pyros, the Company executed a Manufacturing and Supply Agreement (the “Pyros Agreement”)
with Pyros on November 21, 2002. Under the terms of the Pyros Agreement, the Company received an agreed-upon price per drug for the manufacturing
and packaging of Sabril. Revenue per the Pyros Agreement was recognized as control of the manufactured and supplied drugs is transferred
to Pyros (at the time of delivery). The Pyros Agreement was terminated by mutual agreement on January 10, 2025.

Dexcel Agreement for Israel

On
December 6, 2021, the Company entered into the Dexcel Agreement for Amphetamine IR 10mg, Amphetamine IR 20mg and Amphetamine
IR 30mg. 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
2025.

Products
Under Development

Elite’s
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.

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

The
Company filed an NDA for the first product to utilize our abuse-deterrent technology, Immediate Release Oxycodone 5mg, 10mg, 15mg, 20mg
and 30mg with sequestered Naltrexone (collectively and individually referred to as “SequestOx™”), on January 14, 2016.
Please see “Filed products under FDA review; SequestOx™ - Immediate Release Oxycodone with sequestered Naltrexone”
above and please note that continued development of this product is currently paused.

The
Company is currently evaluating the marketplace when deciding to proceed with the above listed filed application.

7

Please
note that, while the FDA is required to review applications within certain timeframes, during the review process, the FDA frequently
requests that additional information be submitted. The effect of such requests and subsequent submissions can significantly extend the
time for the FDA review process. Until a product is actually approved, there can be no assurances that the information requested and
submitted will be considered adequate by the FDA to justify approval. The packaging and labeling of our approved products are also subject
to FDA regulation. Based on the foregoing, it is impossible to anticipate the amount of time that will be needed to obtain FDA approval
and to commercialize a product, if approved. In addition, there can be no assurances of the Company filing the required application(s)
with the FDA or of the FDA approving such application(s) if filed. The Company’s ability to successfully develop and commercialize
products incorporating its abuse-deterrent technology is subject to a high level of risk as detailed in “Item 1A-Risk Factors-Risks
Related to our Business” of this Annual Report on Form 10-K.

Abuse-Deterrent
and Sustained Release Opioids

The
abuse-deterrent opioid products utilize our patented abuse-deterrent technology that is based on a pharmacological approach. These products
are combinations of a narcotic agonist formulation intended for use in patients with pain, and an antagonist, formulated to deter abuse
of the drug. Both, agonist, and antagonist, have been on the market for a number of years and sold separately in various dose strengths.

The
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.

Patents

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

PATENT

EXPIRATION
DATE

U.S.
patent 9,056,054

June
2030

U.S.
patent 10,213,388

June
2030

We
intend to apply for patents for other products in the future; however, there can be no assurance that any of the pending applications
or other applications which we may file will be granted. We have also filed corresponding foreign applications for key patents.

Prior
to the enactment in the United States of new laws adopting certain changes mandated by the General Agreement on Tariffs and Trade (“GATT”),
the 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
any U.S. Patent granted on an application filed subsequent to June 8, 1995 terminates 20 years from the date on which the patent application
was filed in the United States or the first priority date, whichever occurs first. Future patents granted on an application filed before
June 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.

Under
the Drug Price Competition Act, a U.S. product patent or use patent may be extended for up to five years under certain circumstances
to compensate the patent holder for the time required for FDA regulatory review of the product. Such benefits under the Drug Price Competition
Act 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
drug product. There can be no assurance that we will be able to take advantage of this law.

Also,
different countries have different procedures for obtaining patents, and patents issued by different countries provide different degrees
of protection against the use of a patented invention by others. There can be no assurance, therefore, that the issuance to us in one
country of a patent covering an invention will be followed by the issuance in other countries of patents covering the same invention,
or that any judicial interpretation of the validity, enforceability, or scope of the claims in a patent issued in one country will be
similar to the judicial interpretation given to a corresponding patent issued in another country. Furthermore, even if our patents are
determined to be valid, enforceable, and broad in scope, there can be no assurance that competitors will not be able to design around
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.

Trademarks

SequestOx™
is a trademark owned by Elite.

We
currently plan to license at least some of our products to other entities in the marketing of pharmaceuticals but may also sell products
under our own brand name in which case we may register trademarks for those products.

Elite
sells its own products under an “Elite Labs” label.

8

Other
Business Factors and Details

Government
Regulation and Approval

The
design, development, manufacturing, and marketing of pharmaceutical compounds, on which our success depends, are intensely regulated
by governmental regulatory agencies, in particular the FDA and DEA. Non-compliance with applicable requirements can result in fines and
other judicially imposed sanctions, including product seizures, injunction actions and criminal prosecution based on products or manufacturing
practices that violate statutory requirements. In addition, administrative remedies can involve voluntary withdrawal of products, as
well as the refusal of the FDA to approve ANDAs and NDAs. The FDA also has the authority to withdraw approval of drugs in accordance
with statutory due process procedures.

Before
a drug may be marketed, it must be approved by the FDA either through an NDA or an ANDA, each of which is discussed below.

NDAs
and NDAs under Section 505(b)(2) of the Drug Price Competition Act

The
FDA approval procedure for an NDA is generally a two-step process. During the initial product development stage, an investigational new
drug application (“IND”) for each product is filed with the FDA. The IND contains results of animal and in vitro studies
assessing the toxicology, pharmacokinetic, pharmacological, and pharmacodynamics characteristics of the product candidate; chemistry,
manufacturing, and controls information; and any available human data or literature to support the use of the product candidate. A 30-day
waiting period after the filing of each IND is required by the FDA prior to the commencement of initial clinical testing. If the FDA
does not comment on or question the IND within such 30-day period, initial clinical studies may begin. If, however, the FDA has comments
or questions, they must be answered to the satisfaction of the FDA before initial clinical testing may begin. In some instances, this
process could result in substantial delay and expense. Clinical trials are typically conducted in three sequential phases that may overlap
or be combined:

Phase
One: The product candidate is initially introduced into healthy human subjects or patients with the target disease or condition.
These studies are designed to test the safety, dosage tolerance, absorption, metabolism, and distribution of the investigational product
in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. In the case
of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer
to healthy volunteers, the initial human testing;

Phase
Two: The product candidate is administered to a limited patient population with a specified disease or condition to evaluate the
preliminary efficacy, optimal dosages, and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase
2 clinical trials may be conducted to obtain information prior to beginning;

Phase
Three: The product candidate is administered to an expanded patient population to further evaluate dosage, to provide statistically
significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial
sites. These clinical trials are intended to establish the overall risk.

Concurrent
with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry
and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance
with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate
and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final drug.
In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product
candidate does not undergo unacceptable deterioration over its shelf life.

Assuming
successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development
nonclinical and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of
the drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the
product. The submission of an NDA is subject to the payment of substantial user fees; a waiver of such fees may be obtained under certain
limited circumstances.

The
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.

The
FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including
clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be
approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations
carefully when making decisions.

9

Before
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.

After
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.

If
regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the
indicated uses for which such product may be marketed. For example, the FDA may approve the NDA with a Risk Evaluation and Mitigation
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
studies. In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s
policies may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.

The
FDA closely regulates the marketing, labeling, advertising, and promotion of drug products. A company can make only those claims relating
to safety and efficacy that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies
actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can
result in, among other things, adverse publicity, warning letters, corrective advertising, and potential civil and criminal penalties.
Physicians may prescribe, in their independent professional medical judgment, legally available products for uses that are not described
in the product’s labeling and that differ from those tested by us and approved by the FDA. Physicians may believe that such off-label
uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their
choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.
The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and
has enjoined companies from engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies
enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. However, companies
may share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labeling.

Whether
or not FDA approval has been obtained, approval of the product by comparable regulatory authorities in any foreign country must be obtained
prior to the commencement of marketing of the product in that country. We intend to conduct all marketing in territories other than the
United States through other pharmaceutical companies based in those countries. The approval procedure varies from country to country,
can involve additional testing, and the time required may differ from that required for FDA approval. Although there are some procedures
for unified filings for certain European countries, in general each country has its own procedures and requirements, many of which are
time consuming and expensive. Thus, there can be substantial delays in obtaining required approvals from both the FDA and foreign regulatory
authorities after the relevant applications are filed. After such approvals are obtained, further delays may be encountered before the
products become commercially available.

NDAs
under Section 505(b)(2)

Section
505(b)(2) NDAs may provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved products.
Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from clinical trials
not conducted by, or for, the applicant and for which the applicant has not obtained a right of reference. The FDA may then approve the
new product candidate for all, or some, of the label indications for which the referenced product has been approved, as well as for any
new indication sought by the Section 505(b)(2) applicant.

10

To
the extent that the Section 505(b)(2) applicant is relying on the FDA’s findings of safety and effectiveness for an already approved
product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to
the 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
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. 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.

ANDAs

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

In
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.

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

If
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.

In
May 1992, Congress enacted the Generic Drug Enforcement Act of 1992, which allows the FDA to impose debarment and other penalties on
individuals and companies that commit certain illegal acts relating to the generic drug approval process. In some situations, the Generic
Drug 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
certain violations. It also provides for temporary denial of approval of applications during the investigation of certain violations
that could lead to debarment and also, in more limited circumstances, provides for the suspension of the marketing of approved drugs
by the affected company. Lastly, the Generic Drug Enforcement Act allows for civil penalties and withdrawal of previously approved applications.
Neither we nor any of our employees have ever been subject to debarment. We do not believe that we receive any services from any debarred
person.

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Controlled
Substances

The
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 categorizes controlled substances into one of five schedules — Schedule I, II, III, IV or V — with
varying qualifications for listing in each schedule. Schedule I substances by definition have a high potential for abuse, have no currently
accepted medical use in treatment in the United States and lack accepted safety for use under medical supervision. Pharmaceutical products
having a currently accepted medical use that are otherwise approved for marketing may be listed as Schedule II, III, IV or V substances,
with Schedule II substances presenting the highest potential for abuse and physical or psychological dependence, and Schedule V substances
presenting the lowest relative potential for abuse and dependence. The regulatory requirements are more restrictive for Schedule II substances
than Schedule III-V substances.

Facilities
that manufacture, distribute, import or export any controlled substance must register annually with the DEA. The DEA registration is
specific to the particular location, activity(ies) and controlled substance schedule(s). For example, separate registrations are required
for importation and manufacturing activities, and each registration authorizes which schedules of controlled substances the registrant
may handle. Certain coincident activities are permitted without obtaining a separate DEA registration, however, such as distribution
of controlled substances by the manufacturer that produces them.

The
DEA inspects all manufacturing facilities to review security, recordkeeping, reporting and handling prior to issuing a controlled substance
registration. The specific security requirements vary by the type of business activity and the schedule and quantity of controlled substances
handled. The most stringent requirements apply to manufacturers of Schedule I and Schedule II substances. Required security measures
commonly include background checks on employees and physical control of controlled substances through storage in approved vaults, safes
and cages, and through use of alarm systems and surveillance cameras. Once registered, manufacturing facilities must maintain records
documenting the manufacture, receipt and distribution of all controlled substances. Manufacturers must submit periodic reports to the
DEA of the distribution of Schedule I and II controlled substances, Schedule III narcotic substances, and other designated substances.
Registrants must also report any controlled substance thefts or significant losses, and must obtain authorization to destroy or dispose
of controlled substances.

For
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 or II.

Federal
laws have been enacted to address the national epidemics of prescription opioid abuse and illicit opioid use. In 2016, the Comprehensive
Addiction and Recovery Act (“CARA”), was enacted to address the national epidemics of prescription opioid abuse and heroin
use. CARA expands the availability of naloxone for law enforcement and other first responders, forms an interagency task force to develop
best practices for pain management with opioid medications and provides resources to improve state monitoring of opioids. The Substance
Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”), which
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

The
states also maintain separate controlled substance laws and regulations, including licensing, recordkeeping, security, distribution,
and dispensing requirements. State authorities, including Boards of Pharmacy, regulate use of controlled substances in each state. Failure
to maintain compliance with applicable requirements, particularly as manifested in the loss or diversion of controlled substances, can
result in enforcement action that could have a material adverse effect on business, operations and financial conditions. The DEA may
seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to revoke those registrations. In certain circumstances,
violations could lead to criminal prosecution.

12

Other
Healthcare Laws and Compliance Requirements

Our
activities are subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute,
the federal civil False Claims Act, and laws and regulations pertaining to limitations on and reporting of healthcare provider payments
(physician sunshine laws). These laws and regulations are interpreted and enforced by various federal, state and local authorities including
CMS, the Office of Inspector General for the U.S. Department of Health and Human Services, the U.S. Department of Justice, individual
U.S. Attorney offices within the Department of Justice, and state and local governments. These laws include:

●
the
U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting,
offering, receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward
either the referral of an individual for, or the purchase, lease, order, or arranging for or recommending the purchase, lease or
order of, any good or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare
and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order
to have committed a violation;

●
the
U.S. civil False Claims Act (which can be enforced through “qui tam,” or whistleblower actions, by private citizens on
behalf of the federal government and impose civil and criminal penalties), prohibits any person from, among other things, knowingly
presenting, or causing to be presented false or fraudulent claims for payment of government funds or knowingly making, using or causing
to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly and improperly
avoiding, decreasing or concealing an obligation to pay money to the U.S. federal government;

●
U.S.
federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal liability and amends provisions
on the reporting, investigation, enforcement, and penalizing of civil liability for, among other things, knowingly and willfully
executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing
or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for healthcare
benefits, items or services by a healthcare benefit program, which includes both government and privately funded benefits programs;
similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific
intent to violate it in order to have committed a violation;

●
HIPAA,
as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations,
which also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission
of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as
health plans, healthcare clearinghouses and healthcare providers as well as their business associates and their subcontractors that
perform certain services for or on their behalf involving the use or disclosure of individually identifiable health information;

●
state
laws and regulations, including state anti-kickback and false claims laws, that may apply to our business practices, including but
not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed
by any third-party payer, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical
industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government,
or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws and
regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking
gifts and other remuneration and items of value provided to healthcare professionals and entities; and

●
the
Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, requires certain manufacturers
of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health
Insurance Program to report annually to CMS information related to certain payments made in the preceding calendar year and other
transfers of value to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their
immediate family members; beginning in 2022, applicable manufacturers are required to report such information regarding payments
and transfers of value provided, as well as ownership and investment interests held, during the previous year to physician assistants,
nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.

13

Violations
of any of these laws or any other governmental regulations that may apply to us, may subject us to significant civil, criminal and administrative
sanctions including penalties, damages, fines, imprisonment, and exclusion from government funded healthcare programs, such as Medicare
and Medicaid, and/or adverse publicity.

Moreover,
government entities and private litigants have asserted claims under state consumer protection statutes against pharmaceutical companies
for alleged false or misleading statements in connection with the marketing, promotion and/or sale of pharmaceutical products, including
state investigations and litigation by certain government entities regarding the marketing of opioid products.

Foreign
Corrupt Practices Act

The
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. governments. 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. Recently, the SEC and DOJ have increased their FCPA enforcement activities with respect to pharmaceutical companies. Violations
could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of our facilities, requirements
to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions
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.

Coverage
and Reimbursement

Sales
of any pharmaceutical product depend, in part, on the extent to which such product will be covered by third-party payors, such as federal,
state, and foreign government healthcare programs, commercial insurance, and managed healthcare organizations, and the level of reimbursement
for such product by third-party payors. Significant uncertainty exists as to the coverage and reimbursement status of any newly approved
product. Decisions regarding the extent of coverage and amount of reimbursement to be provided for any product are made on a plan-by-plan
basis. One third-party payor’s decision to cover a particular product does not ensure that other payors will also provide coverage
for the product. As a result, the coverage determination process can require manufacturers to provide scientific details, information
on cost-effectiveness, and clinical support for the use of a product to each payor separately. This can be a time-consuming process,
with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

In
addition, third-party payors are increasingly reducing reimbursements for pharmaceutical products and related services. The U.S. government
and state legislatures have continued implementing cost-containment programs, including price controls and restrictions on coverage and
reimbursement. Third-party payors are increasingly challenging the prices charged, examining the medical necessity and reviewing the
cost effectiveness of pharmaceutical products, in addition to questioning their safety and efficacy. Adoption of price controls and cost-containment
measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of
any product. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could
reduce physician usage and patient demand for the product.

The
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.

Drugs
with an available generic or biosimilar, certain drugs that represent a limited portion of Medicare program spending, drugs with an orphan
designation as their only FDA approved indication, and all plasma-derived products are exempt from direct negotiation. The number of
negotiated products will be phased in between 2026 and 2029, and the law sets a maximum fair price the manufacturer can charge based
on the number of years the product has been on the market. The law allows HHS to levy an excise and civil monetary penalties against
non-compliant manufacturers or those who refuse to negotiate.

14

The
IRA also imposes rebate requirements on manufacturers of single-source generics and other drugs covered under Medicare Part B and Part
D where the price of the drug increases faster than inflation. Multisource generics and all products with an average manufacturer’s
price less than $100 per year, per individual, are exempt from rebate requirements. Beginning on October 1, 2022 for Part D products
and on January 1, 2023 for Part B products, CMS will monitor for products with price increases higher than the rate of inflation on a
quarterly basis. Rebates will be calculated as the total number of units sold by the amount the product exceeds the inflation-adjusted
price, with 2021 as the base year to measure cumulative changes relative to inflation. Noncompliant manufacturers will be subject to
a civil monetary penalty of at least 125% of the calculated rebate amount.

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

We
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 (“MFN”) 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, 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

Compliance
with Environmental Laws

We
are subject to comprehensive federal, state and local environmental laws and regulations that govern, among other things, air polluting
emissions, waste water discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or
past generation handling and disposal activities, including the past practices of corporations as to which we are the legal successor
or in possession. We do not expect that compliance with such environmental laws will have a material effect on our capital expenditures,
earnings, or competitive position in the foreseeable future. There can be no assurance, however, that future changes in environmental
laws or regulations, administrative actions or enforcement actions, or remediation obligations arising under environmental laws will
not have a material adverse effect on our capital expenditures, earnings, or competitive position.

Competition

The
Company has competition with respect to our principal areas of operation. We develop, manufacture and distribute generic products. Elite’s
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. 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.

Sources
and Availability of Raw Materials; Manufacturing

A
significant portion of our raw materials may be available only from foreign sources. Foreign sources can be subject to the special risks
of doing business abroad, including:

●
Greater
possibility for disruption due to transportation or communication problems;

●
The
relative instability of some foreign governments and economies;

●
Interim
price volatility based on labor unrest, materials or equipment shortages, export duties, restrictions on the transfer of funds, or
fluctuations in currency exchange rates; and

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

While
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
have acquired pharmaceutical manufacturing equipment for manufacturing our products. We have registered our facilities with the FDA and
the DEA.

15

Our
Reporting Segments

We
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.

Segment
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 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.

Employees

As
of June 25, 2026, we had 65 full-time employees. Full-time employees are engaged in operations, administration, research, and development.
None of our employees is represented by a labor union and we have never experienced a work stoppage. We believe our relationship with
our employees to be good. However, our ability to achieve our financial and operational objectives depends in large part upon our continuing
ability to attract, integrate, retain, and motivate highly qualified personnel, and upon the continued service of our senior management
and key personnel.