What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2024-07-01 compared with 2023-06-29 · 213 added, 161 removed, 710 unchanged (35% of the section changed)

10 unchanged sentences

high barriers to entry.

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

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

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

8 unchanged sentences

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;

and (v) development of

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

co-development projects, joint ventures and other collaborations.

(iv) commercial exploitation of our product candidates

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

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

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

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

2 unchanged sentences

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

HCl 37.5mg tablets (“Phentermine 37.5mg”)

Phendimetrazine

Tartrate 35mg tablets (“Phendimetrazine 35mg”)

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

HCl 50mg tablets (“Naltrexone 50mg”)

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

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

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

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

November 2012

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

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

September 2013

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

Cardiovascular

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

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

Antidepressant

Dextroamphetamine

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

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

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

Nervous System (“CNS”) Stimulant

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

Dextroamphetamine

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

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

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

Nervous System (“CNS”) Stimulant

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

and Loxapine 50mg”)

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

Central Nervous System (“CNS”) Stimulant

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

Muscle Relaxant

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

Central Nervous System (“CNS”) Stimulant

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

Antipsychotic

Vigabatrin Powder 500mg (“Vigabatrin 500mg”)

Anti-epileptic

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

14 unchanged sentences

Loxapine 5gm, Loxapine 10mg, Loxapine

25mg and Loxapine 50mg are collectively and individually referred to as “Loxapine Capsules”.

approved ANDA for Phentermine 37.5mg was acquired pursuant to an asset purchase agreement with Epic Pharma LLC (“Epic”) dated

September 10, 2010 (the “Phentermine Purchase Agreement”).

and marketing rights for Phentermine 37.5mg are included in the licensing agreement between the Company and Precision Dose Inc.

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

Please see the section below titled “Precision

Dose License Agreement” for further details of this agreement.

37.5mg is currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.

25mg and Loxapine 50mg are collectively and individually referred to as “Loxapine Capsules”, Vigabatrin 500mg is collectively

and individually referred to as “Vigabatrin Powder”.

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

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

the Company and Precision Dose Inc.

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

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

is currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.

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

10 unchanged sentences

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.

6 unchanged sentences

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

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

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

25mg, Trimipramine 50mg and Trimipramine 100mg

approved ANDA for Trimipramine was acquired by Elite in 2017.

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

and distributed by Elite Labs.

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

4 unchanged sentences

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 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

3 unchanged sentences

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 Elite Labs.

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”).

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

Dantrolene Capsules are a commercial

product being manufactured by Elite at the Northvale Facility and distributed by Elite Labs.

approved ANDA for Loxapine was acquired by Elite in 2013.

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.

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

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

The product is in the anti-epileptic therapeutic category.

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

(“Pyros”) dated November 21,

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

ANDA for Vigabatrin Powder.

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

Agreement”), pursuant to which the Company manufactures and supplies to Pyros Vigabatrin Powder at an agreed upon price over a

term of three years.

Powder is currently being manufactured by Elite at the Northvale Facility and commercially launched and marketed by Pyros since January

Under FDA Review

37 unchanged sentences

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 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 Filed

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

dopamine agonist accepted for review in December 2022

antimetabolite accepted for review in April 2023

opiate analgesic for pain management accepted for review in September 2023

central nervous system stimulant accepted for review in December 2023

Products Not Yet Commercialized

6 unchanged sentences

are inadequate.

Acetaminophen with codeine products have annual U.S.

sales of approximately $45 million according to IQVIA (formerly

QuintilesIMS Health Data).

The Company is not pursuing licensing deals for any opioids at this time until the market changes.

will wait for the market to stabilize before pursuing these opportunities.

The Company is currently assessing commercialization options for this product.

Hyclate Tablets

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

The product is jointly owned by Elite and Praxgen Pharmaceuticals LLC, formerly

SunGen Pharma LLC, (“Praxgen”).

Sodium Tablets

May 10, 2024, the Company received approval from the FDA for an ANDA for generic Methotrexate Sodium 2.5 mg tablets.

Methotrexate belongs

to a class of drugs known as antimetabolites and will be sold under the Elite Laboratories, Inc.

Bitartrate and Acetaminophen Tablets

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 to this product 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.

Hydrochloride and Acetaminophen Tablets

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 to this product 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.

Hydrochloride Tablets

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 to this product 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.

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

1 unchanged sentence

made to secure these marketing authorizations.

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”) .

and Transferred Products

3 unchanged sentences

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 (“GDUFA”) which is significantly

influenced by the number of ANDAs owned, and other costs and benefits taking into consideration various specific market factors for each

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.

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.

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.

Company did not transfer or discontinue any ANDAs during Fiscal 2023 or Fiscal 2024.

Manufacturing and Development Agreements

Dose License Agreement

September 10, 2010, we executed a License Agreement with Precision Dose (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.

37.5mg was launched in April 2011.

September 10, 2010, the Company executed a License Agreement with Precision Dose (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.

Phentermine 15mg and Phentermine 30mg were

launched in April 2013.

Naltrexone 50mg was launched in September 2013.

Precision Dose will have 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.

Precision Dose will have the exclusive right to market these

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

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

11 unchanged sentences

License with Epic Pharma LLC

November 21, 2020 we entered into a license, manufacturing and supply agreement with Epic Pharma LLC (“Epic”) to market the

two Elite generic products described below in the United States (the “Epic Pharma License”).

November 21, 2020 we entered into a license, manufacturing and supply agreement with Epic Pharma LLC to market the two Elite generic

products described below in the United States.

on May 23, 2021 and continuing until the agreement terminates, Epic has exclusive marketing rights to Trimipramine Capsules and Isradipine

4 unchanged sentences

This license was terminated as of March 31, 2023.

License with Prasco, LLC and Burel Pharmaceuticals, Inc.

Loxapine License Agreement

February 14, 2020, and as amended on July 30, 2020, the Company entered into a license, manufacturing and supply agreement with Prasco,

1 unchanged sentence

(“Burel”) to market generic Loxapine Succinate capsules in the United States.

(the “Burel License”).

Burel sales for the product began in May 2021.

4 unchanged sentences

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.

Non-Exclusive License Agreement

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 term of the agreement

is two years from January 1, 2024.

First commercial sale by Prasco of this product was April 5, 2024.

Marketing Alliances with Lannett Company Inc.

42 unchanged sentences

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).

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

Asset Purchase Agreement

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 ANDA 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.

Manufacturing and Supply Agreement

conjunction with the sale of its Product to Pyros, the Company executed a Manufacturing and Supply Agreement (the “Pyros Agreement”)

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

4 unchanged sentences

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.

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

with sequestered Naltrexone (collectively and individually referred to as “SequestOx™”), on January 14, 2016.

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.

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.

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.

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

21 unchanged sentences

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

The Company owns the following patents:

patent 8,182,836

patent 8,425,933

patent 8,703,186

patent 2,521,655

Company owns the following patents (as of March 31, 2024):

EXPIRATION DATE

patent 8,425,933

Canadian patent 2,541,371

patent 9,056,054

31 unchanged sentences

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.

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

Business Factors and Details

75 unchanged sentences

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

one or more clinical sites to assure compliance with 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.

one or more clinical sites to assure compliance with good clinical practices, or GCPs.

If the FDA determines that the application, manufacturing

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

testing or information.

Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the

application does not satisfy the regulatory criteria for approval.

the FDA evaluates an NDA, it will issue an approval letter or a Complete Response Letter.

12 unchanged sentences

indicated uses for which such product may be marketed.

For example, the FDA may approve the NDA with a 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

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.

For example, the FDA may approve the NDA with a Risk Evaluation and Mitigation

Strategy, or 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

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.

183 unchanged sentences

These laws include:

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.

entity does not need to have actual knowledge of the statute or specific intent to violate

it in order to have committed a violation;

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;

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.

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;

7 unchanged sentences

intent to violate it in order to have committed a violation;

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;

laws and regulations, including state anti-kickback and false claims laws, that may apply to our business practices, including but

64 unchanged sentences

reduce physician usage and patient demand for the product.

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

price negotiation program within the U.S.

Department of Health and Human Services that would require manufacturers to charge a negotiated

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

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

and requires manufacturers to provide discounts on Part D drugs.

Substantial penalties can be assessed for noncompliance with the drug

pricing provisions.

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

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.

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.

effect of the Inflation Reduction Act of 2022 on our business, generic manufacturers, and the pharmaceutical industry in general is not

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, once approved, or additional pricing pressures.

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

with Environmental Laws

69 unchanged sentences

Reporting Segments

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

approvals were secured via an NDA.

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

pharmaceuticals.

For the years ended March 31, 2023 and 2022 revenue from our ANDA segment were $34.2 million and $32.3 million, respectively.

For the years ended March 31, 2023 and 2022 revenue from our NDA segment were $0.0 million and $0.0 million, respectively.

currently operate in two segments, which are products whose marketing approvals were secured via an ANDA and 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 fiscal year ended March 31, 2024 and 2023, the Company has paused further development of NDAs

and has not engaged in business activities.

Accordingly during March 31, 2024 and 2023, results the Company has only engaged in

business activities in a single operating segment.

For the years ended March 31, 2024 and 2023 revenue from our ANDA segment were

$56.6 million and $34.2 million, respectively.

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

12 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