What changed in this filing

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Item 1. Business

2023-06-29 compared with 2022-06-29 · 174 added, 225 removed, 697 unchanged (36% of the section changed)

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the manufacture of generic pharmaceuticals.

Our strategy includes developing generic versions of controlled-release drug products

with high barriers to entry.

Our strategy includes developing generic versions of controlled-release drug products with

high barriers to entry.

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

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

Our website address

is www.elitepharma.com.

Our website address is

www.elitepharma.com.

focus our efforts on the following areas:

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(iii) development of the other

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

(iv) commercial exploitation of our products either by sales

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;

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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 that includes both branded and

generic products in various therapeutic categories and to build collaborations and establish licensing agreements with companies with

greater resources thereby allowing us to share costs of development and improve cash-flow.

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

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

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

Product Equivalent

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Cardiovascular

HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets (“OXY IR 5mg”, “Oxy IR 10mg”, “Oxy IR

15mg”, “OXY IR 20mg” and “Oxy IR 30mg”)

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

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referred to as “Isradipine Capsules”.

Oxy IR 5mg, Oxy IR 10mg, Oxy IR 15mg Oxy IR 20mg and Oxy IR 30mg are collectively and

individually referred to as “Oxy IR”.

Trimipramine 25mg, Trimipramine 50mg, and Trimipramine 100mg are collectively and individually

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Phendimetrazine

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

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

15mg and Phentermine 30mg

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

Phentermine 37.5mg

The ANDA for Phentermine was acquired by Elite in 2013.

Phentermine 37.5mg is currently a commercial product 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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approved ANDAs for Isradipine 2.5mg and Isradipine 5mg were acquired by Elite in 2013

2.5mg and Isradipine 5mg are currently a commercial product being manufactured by Elite at the Northvale Facility and distributed by

Epic Pharma LLC (“Epic”), on an exclusive basis.

5mg, Oxycodone 10mg, Oxycodone 15mg, Oxycodone 20mg and Oxycodone 30mg (“Oxy IR”)

product was an Identified IR Product in the Epic Strategic Alliance Agreement Dated March 18, 2009 (the “Epic Strategic Alliance”).Methods

used by Epic in the manufacture of Oxy IR were developed at the Northvale Facility pursuant to the Epic Strategic Alliance, in which

we are entitled to a Product Fee of 15% of Profits through March 2026, as defined in the Epic Strategic Alliance.

The first commercial

sale of Oxy IR occurred in March 2016.

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

25mg, Trimipramine 50mg and Trimipramine 100mg

approved ANDA for Trimipramine was acquired by Elite in 2017.

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

and distributed by Epic, on an exclusive basis.

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

and distributed by Elite Labs.

December 10, 2018, the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall®, an immediate-release

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and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

IR Tablets are currently a commercial product being manufactured by Elite and distributed by Lannett Company Inc.

on an exclusive basis.

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

approved ANDAs for Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg were acquired by Elite in 2013.

Dantrolene Capsules are currently

a commercial product being manufactured by Elite at the Northvale Facility and distributed by Lannett, on an exclusive basis.

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

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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stimulant and is indicated for the treatment of ADHD and Narcolepsy.

ER Capsules are currently a commercial product being manufactured by Elite and distributed by Lannett, on an exclusive basis.

ER Capsules are currently a commercial product being manufactured by Elite and distributed by Elite Labs.

approved ANDA for Loxapine was acquired by Elite in 2013.

Loxapine Succinate 5, 10, 25 and 50 mg are currently commercial products being

Loxapine Succinate 5, 10, 25 and 50 mg are commercial products being

manufactured by Elite at the Northvale Facility, launched commercially in May 2021 and distributed by Burel Pharmaceuticals, Inc, an

affiliate of Prasco, LLC (“Burel”), on an exclusive basis.

Products Under FDA Review

Under FDA Review

- Immediate Release Oxycodone with sequestered Naltrexone

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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.

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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be in amounts that provide adequate return on the significant investments made to secure this marketing authorization.

Hydrochloride extended release (generic version of OxyContin®)

September 20, 2017, the Company filed an ANDA with the FDA for generic version of OxyContin® (extended release Oxycodone Hydrochloride).

OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and

for which alternative treatment options are inadequate.

IMS reported approximately $2.3 billion in revenue for OxyContin® and its

equivalents in 2016.

The FDA requested additional information relating to this filing, compliance with which would require significant

Development of this product has been reinitiated with a target filing in Q1 2023 .

can be no assurances that any of these products will receive marketing authorization and achieve commercialization.

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 these marketing authorizations.

Generic Products Filed

Currently the Company has filed a generic antimetabolite ANDA and a generic dopamine agonist ANDA and these products

are under review by the FDA.

The Company also submitted an ANDA for pain management and intends to provide supplemental data in Q3 2023

to complete the filing.

Products Not Yet Commercialized

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made to secure these marketing authorizations.

version of an antibiotic product

January 3, 2019, the Company filed an ANDA with the FDA for a generic version of an antibiotic product.

According to QVIA (formerly QuintilesIMS

Health) data, the branded product for this antibiotic and its equivalents had total annual U.S.

sales of approximately $85 million for

the twelve months ending September 30, 2019.

Doxycycline Hyclate Tablets

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

According to QVIA (formerly

QuintilesIMS Health) data, the branded product for this antibiotic and its equivalents had total annual U.S.

sales of approximately $85

million for the twelve months ending September 30, 2019.

The product is jointly owned by Elite and Praxgen

Pharmaceuticals LLC, formerly SunGen Pharma LLC, (“Praxgen”) .

The product was approved in April 2022.

Pharmaceuticals LLC,

formerly SunGen Pharma LLC, (“Praxgen”) .

and Transferred Products

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for the products, distribution fees of less than 10% and shipping costs.

The initial term of the agreement is three (3) years from the

execution of the agreement.

Epic has the option to extend the agreement for an additional two (2) years if certain license fee targets

This license was terminated as of March 31, 2023.

License with Prasco, LLC and Burel Pharmaceuticals, Inc.

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distribution fees of less than 10% and shipping costs.

The term of the agreement is three (3) years from the execution date of the agreement

and will automatically renew for one (1) year periods unless one of the parties gives prior written notice.

This agreement was terminated as of March 31, 2023.

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 “New

Burel License”).

The term of the agreement is two years from January 1, 2024 or the date of the first commercial sale, whichever

occurs first.

Marketing Alliances with Lannett Company Inc.

Company has entered into two separate license, supply and distribution agreements with Lannett Company Inc.

The first agreement, dated March 6, 2019, relates to products that were co-developed with Praxgen

(the “Lannett- Praxgen Product Alliance”).

The second agreement, dated April 9, 2019, relates to products

that were solely developed by Elite (the “Lannett-Elite Product Alliance”).

Both agreements are collectively and individually

referred to as the “Lannett Alliance”).

The first agreement, dated March 6, 2019, relates to products that were co-developed with Praxgen (the “Lannett-Praxgen Product

The second agreement, dated April 9, 2019, relates to products that were solely developed by Elite (the “Lannett-Elite

Product Alliance”).

Both agreements are collectively and individually referred to as the “Lannett Alliance”).

to Lannett-Praxgen Product Alliance with Lannett, Lannett will be the exclusive U.S.

distributor for Amphetamine IR Tablets and

Amphetamine ER Capsules.

Elite manufactures these products, which are purchased, marketed and distributed by Lannett under the Lannett

In addition to the purchase prices for the products, Elite will receive license fees well in excess of 50% of net profits, which

will be shared equally with Praxgen, pursuant to the Praxgen Agreement.

Net profits are defined as net sales less the price

paid to Elite for the products, distribution fees (less than 10%) and shipping costs.

The Lannett- Praxgen Product Alliance has

an initial term of three years and automatically renews for one year periods absent prior written notice of non-renewal.

to customary termination provisions, the Agreement permits Lannett to terminate with regard to a product on at least three months’

prior written notice if it determines to stop marketing and selling such product, and it permits Elite to terminate with regard to a

product if at any time after the first twelve months from the first commercial sale, the average license fee paid by Lannett for such

product is less than $100,000 for a six month sales period.

In addition to manufacturing fees and license fees, Lannett also paid a $750,000

milestone, upon the March 2020 commercial launch of Amphetamine ER Capsules.

This milestone payment was earned during March 2020 and

was shared equally by Elite and Praxgen, pursuant to the Praxgen Agreement.

first commercial shipment of Amphetamine IR Tablets, a generic version of Adderall®, with strengths of 5mg, 7.5mg, 10mg, 12.5mg,

15mg, 20mg and 30mg, pursuant to the Lannett- Praxgen Product Alliance occurred in April 2019.

first commercial shipment of Amphetamine ER Capsules, a generic version of Adderall XR®, with strengths of 5mg, 10mg, 15mg, 20mg,

25mg and 30mg, pursuant to the Lannett- Praxgen Product Alliance occurred in March 2020.

to the Lannett-Elite Product Alliance, Lannett will be the exclusive U.S.

distributor for Dantrolene Capsules.

The first commercial shipment

of Dantrolene Capsules, with strengths of 25mg, 50mg and 100mg occurred in June 2019.

distributor for Amphetamine IR Tablets and Amphetamine

Elite manufactures these products, which are purchased, marketed and distributed by Lannett under the Lannett label.

addition to the purchase prices for the products, Elite will receive license fees well in excess of 50% of net profits, which will be

shared equally with Praxgen, pursuant to the Praxgen Agreement.

Net profits are defined as net sales less the price paid to Elite for

the products, distribution fees (less than 10%) and shipping costs.

The Lannett-Praxgen Product Alliance has an initial term of three

years and automatically renews for one year periods absent prior written notice of non-renewal.

In addition to customary termination

provisions, the Agreement permits Lannett to terminate with regard to a product on at least three months’ prior written notice

if it determines to stop marketing and selling such product, and it permits Elite to terminate with regard to a product if at any time

after the first twelve months from the first commercial sale, the average license fee paid by Lannett for such product is less than $100,000

for a six month sales period.

In addition to manufacturing fees and license fees, Lannett also paid a $750,000 milestone, upon the March

2020 commercial launch of Amphetamine ER Capsules.

This milestone payment was earned during March 2020 and was shared equally by Elite

and Praxgen, pursuant to the Praxgen Agreement.

to the Lannett-Elite Product Alliance, Elite manufactures for Lannett’s purchase, marketing, and distribution of Dantrolene Capsules

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In addition to manufacturing fees and license fees.

also note that in May 2020, Praxgen, under an asset purchase agreement, assigned its rights and obligations under the Praxgen

Agreement for Amphetamine IR and Amphetamine ER to Mikah.

The ANDAs for Amphetamine IR and Amphetamine ER are now registered under

Elite’s name.

Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and

obligations for these products from Praxgen.

also note that in May 2020, Praxgen, under an asset purchase agreement, assigned its rights and obligations under the Praxgen Agreement

for Amphetamine IR and Amphetamine ER to Mikah.

The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s

Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations for

these products from Praxgen.

All agreements with Lannett were terminated as of March 31, 2023.

Pyros Agreement

On November 21, 2022, the Company entered into an agreement with Pyros Pharmaceuticals, Inc.

(“Pyros”) pursuant to which the Company sold to Pyros its rights in and to the Company’s approved abbreviated new drug

applications (ANDAs) for its generic Sabril drug.

The Company sold its rights to Pyros for $1,000,000, which was recorded as gain on sale

of ANDA during the year ended March 31, 2023.

There is no further action required by the Company regarding the rights which would

affect future periods.

In conjunction with the sale of its Product to Pyros, the Company executed a Manufacturing and Supply agreement (the

“Pyros Agreement”) with Pyros.

Under the terms of the Pyros Agreement, the Company will receive an agreed-upon price per drug

for the manufacturing and packaging of Sabril over a term of three years.

Revenue per the Pyros Agreement will be recognized as control

of the manufactured and supplied drugs is transferred to Pyros (at the time of delivery).

Under Development

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dependence and opioid dependence.

When this product is taken as intended, the naltrexone is designed to pass through the body unreleased

while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed.

If the multi-particulate beads

are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release.

The absorption of the naltrexone is intended to

block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive

for abuse or misuse by recreational drug abusers.

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.

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.

filed an NDA for the first product to utilize our abuse deterrent technology, Immediate Release Oxycodone 5mg, 10mg, 15mg, 20mg and 30mg

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please note that continued development of this product is currently paused.

Company is currently not selling and is evaluating the market place when deciding to proceed with the above listed filed applications.

Company is currently not selling and is evaluating the market place when deciding to proceed with the above listed filed application.

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.

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

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Company is currently not selling opioids and is evaluating the market place when deciding to proceed with the above listed filed applications.

our incorporation, we have secured the following patents, of which two have been assigned for a fee to another pharmaceutical company.

Our patents are:

The Company owns the following patents:

patent 8,182,836

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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.

Business Factors and Details

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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.

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.

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.

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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.

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

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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.

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:

waiting period after the filing of each IND is required by the FDA prior to the commencement of initial clinical testing.

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:

The product candidate is initially introduced into healthy human subjects or patients with the target disease or condition.

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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;

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;

The product candidate is administered to a limited patient population with a specified disease or condition to evaluate the

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communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization

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.

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 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.

FDA closely regulates the marketing, labeling, advertising, and promotion of drug products.

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

In November 2017, the DEA reduced the amount of almost

every Schedule II opiate and opioid medication that may be manufactured in the U.S.

in calendar year 2018 by 20%.

For 2019, the DEA proposed

decreased manufacturing quotas for the six most frequently misused opioids, including oxycodone, by an average of 10% as compared to

the 2018 quotas.

The DEA proposed further decreasing manufacturing quotas in 2020 for five of the six opioids (fentanyl, hydrocodone,

hydromorphone, oxycodone, oxymorphone), by an average of 28%.

In October 2019, the DEA proposed additional regulations to amend the manner

in which the agency grants quotas to manufacturers.

The proposed regulations will establish use-specific quotas, including commercial

sales, product development, transfer, replacement and packaging.

To decrease the risk of diversion and increase accountability, inventory

allowances will be reduced, and procurement quota certifications will be required.

In April 2020 in response to the COVID-19 pandemic,

the DEA adjusted the established 2020 aggregate production quotas and assessment of annual needs for select Schedule II substances.

DEA took this action to ensure that the country has an adequate and uninterrupted supply of these substances during the public health

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

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Healthcare Laws and Compliance Requirements

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).

and regulations are interpreted and enforced by various federal, state and local authorities including CMS, the Office of Inspector General

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.

Department of Justice, individual

Attorney offices within the Department of Justice, and state and local governments.

These laws include:

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it in order to have committed a violation;

civil False Claims Act (which can be enforced through “qui tam,” or whistleblower

actions, by private citizens on behalf of the federal government), 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

civil False Claims Act (which can be enforced through “qui tam,” or whistleblower actions, by private citizens on

behalf of the federal government), 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;

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;

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;

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;

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;

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.

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;

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;

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.

of any of these laws or any other governmental regulations that may apply to us, may subject us to significant civil, criminal and administrative

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relative instability of some foreign governments and economies;

price volatility based on labor unrest, materials or equipment shortages, export duties,

restrictions on the transfer of funds, or fluctuations in currency exchange rates;

● Uncertainty

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

price volatility based on labor unrest, materials or equipment shortages, export duties, restrictions on the transfer of funds, or

fluctuations in currency exchange rates;

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

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We have registered our facilities with the FDA and

see the Risk Factor in Part I, Item 1A entitled “ We are dependent on a small number of customers, suppliers and other third

parties for core business aspects.

on One or a Few Major Customers

year we have had one or a few customers that have accounted for a large percentage of our limited revenues, therefore the termination

or restructuring of a contract with a customer may result in the loss of material amount or substantially all of our revenues.

constantly working to develop new relationships with existing or new customers, but despite these efforts we may not, at the time that

any of our current contracts expire, have other contracts in place generating similar or material revenue.

We have agreements with Lannett

Company, Prasco, LLC, Epic Pharma, LLC, and TAGI Pharma, LLC for the licensing, sales and distribution of products that we manufacture.

We receive revenues to manufacture these products and also receive a profit split or royalties based on in-market sales of the products.

Please see the Risk Factor in Part I, Item 1A entitled “ We are dependent on a small number of customers, suppliers and other

third parties for core business aspects.

Reporting Segments

19 unchanged sentences

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