What changed in this filing

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Item 1. Business

2025-06-30 compared with 2024-07-01 · 196 added, 236 removed, 687 unchanged (39% of the section changed)

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

Branded Product Equivalent

Therapeutic Category

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

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Anti-epileptic

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

Antimetabolite

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

Tylenol® with Codeine

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

December 2024

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

December 2024

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

April 2025 (Subsequent to year-end)

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

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ER 30mg are collectively and individually referred to as “Amphetamine ER Capsules”.

Loxapine 5gm, Loxapine 10mg, Loxapine

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

and individually referred to as “Vigabatrin Powder”.

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”.

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.

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

between the Company and Precision Dose Inc.

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

License Agreement”).

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

this agreement.

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

(“TAGI”) under

the Precision Dose License Agreement.

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

Northvale Facility and distributed by Elite Labs.

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

engage in commercial operations with this product.

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

Phendimetrazine

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15mg and Phentermine 30mg

15mg capsules and Phentermine 30mg capsules were developed by the Company, with Elite receiving approval from the United States Food

and Drug Administration (“FDA”) of the related ANDA in September 2012.

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

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

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The product is a central nervous system stimulant

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

and 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 Elite Labs.

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

The Company will manufacture

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

under the Dexcel Pharma label.

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

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

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

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

acquired by Elite in 2013.

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

distributed by Elite Labs.

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

future cash flows for this product.

approved ANDA for Loxapine was acquired by Elite in 2013.

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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

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

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

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

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

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

Codeine 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 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.

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

Hydrocodone Tablets

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.

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

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

Deficit Hyperactivity Disorder.

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

and distributed by Elite Labs.

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

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

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

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

Under FDA Review

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of July 14, 2016.

July 15, 2016, the FDA issued a Complete Response Letter, or CRL, regarding the NDA.

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

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

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

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

The mean Tmax (the

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

the new formulation to the original SequestOx™ studies and also extended our filing fee waiver until July 2023.

the new formulation to the original SequestOx™ studies.

Due to the prohibitive

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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

Acetaminophen

and Codeine Phosphate

Company received approval on September 10, 2019 from the FDA of an ANDA for a generic version of Tylenol® with Codeine (acetaminophen

and codeine phosphate) 300mg/7.5mg, 300mg/15mg, 300mg/30mg and 300mg/60mg tablets.

Acetaminophen with codeine is a combination medication

indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments

are inadequate.

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.

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

The product is jointly

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

Hydrochloride Tablets

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.

to the Nostrum Asset Purchase

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

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

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

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

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

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

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

Codeine Tablets

Hydrocodone Tablets

Hydrochloride Tablets

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

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

Manufacturing and Development Agreements

Dose License Agreement

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

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.

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Naltrexone 50mg was launched in September 2013.

Precision Dose will have the exclusive right to market these

Precision Dose has the exclusive right to market these

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

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

The license fee will be computed as

The license fee is computed as

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

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

The milestone payments will be

The milestone payments are to be

paid in six installments.

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The term of the Precision Dose License Agreement

is 15 years and may be extended for 3 successive terms, each of 5 years.

License with Epic Pharma LLC

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

The products are manufactured by Elite for Epic on a cost-plus basis.

In addition to the purchase prices for the products,

Elite also receives license fees of 50% of gross profits or greater, with such being defined as net sales less the price paid to Elite

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

This license was terminated as of March 31, 2023.

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,

LLC and its affiliate Burel Pharmaceuticals, Inc.

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

Burel sales for the product began in May 2021.

the agreement, Burel has exclusive marketing rights to Loxapine.

The product is manufactured by Elite, and the Company receives manufacturing

fees and license fees of 50% of gross profits or greater, with such being defined as net sales less the price paid to Elite for the products,

distribution fees of less than 10% and shipping costs.

This agreement was terminated as of March 31, 2023.

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

Non-Exclusive License Agreement

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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.

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

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

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

under the Lannett label.

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

gross profits.

Gross profits are defined as net sales less the price paid to Elite for the products, distribution fees (less than 10%)

and shipping costs.

Lannett will have exclusive marketing rights to Dantrolene Capsules.

The Lannett-Elite 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.

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.

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.

The agreement commenced on

January 1, 2024 and was terminated with notice on March 31, 2025.

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).

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.

Under Development

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

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

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

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

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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.

Company is currently evaluating the marketplace 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

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

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

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

proceed with the above listed filed applications.

Company owns the following patents (as of March 31, 2025):

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patent 9,056,054

Canadian patent 2,541,371

patent 10,213,388

intend to apply for patents for other products in the future;

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limited circumstances.

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

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

Under the Prescription Drug User

Fee Act, or 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

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

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

accept an NDA for filing.

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

The resubmitted application is

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

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

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

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

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

This review typically

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

“filing” decision after the application is submitted.

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

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

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

In this event, the NDA must be

resubmitted with the additional information.

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

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

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

The FDA will not approve

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

consistent production of the product within required specifications.

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

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

The FDA will not

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

to assure consistent production of the product within required specifications.

Additionally, before approving an NDA, the FDA will

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

If the FDA determines that the

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

submission and often will request additional testing or information.

Notwithstanding the submission of any requested additional

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

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

An approval letter authorizes commercial marketing

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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.

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

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

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the referenced product have expired;

until any non-patent exclusivity, such as exclusivity for obtaining approval of a NCE, listed in

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

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

obtain approval of a generic drug, an applicant must submit an abbreviated new drug application, or ANDA, to the agency.

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

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

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

listed drug, or RLD.

order for an ANDA to be approved, the FDA must find that the generic version is identical to the RLD with respect to the active ingredients,

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

listed drug (“RLD”).

order for an ANDA to be approved, the FDA must find that the generic version is identical to the RLD with respect to the active ingredients, route of administration, dosage form, strength of the drug and conditions of use of the drug.

At the same time, the FDA

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physician or patient.

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

product in the FDA’s Orange Book.

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:

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

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

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.

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

federal Controlled Substances Act of 1970, or 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 Drug Enforcement Agency, or 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.

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.

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

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of controlled substances.

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

I and II that may be manufactured or produced in the United States based on the DEA’s estimate of the quantity needed to meet legitimate

medical, scientific, research and industrial needs.

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

and production of dosage forms.

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

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

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

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

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

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

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

use-disorder and increased coverage by CMS of medically-assisted treatment options.

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

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Corrupt Practices Act

Foreign Corrupt Practices Act, or the FCPA, generally prohibits offering, promising, giving, or authorizing others to give anything of

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.

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

the SEC and Department of Justice have increased their FCPA enforcement activities with respect to pharmaceutical companies.

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

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

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on the conduct of our business.

Enforcement actions may be brought by the Department of Justice or the Securities and Exchanges Commission

(“SEC”), and recent enacted legislation has expanded the SEC’s power to seek disgorgement in all FCPA cases filed in

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

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

price negotiation program within the U.S.

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

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

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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

effect of the IRA 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

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

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

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

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

Under the order, most-favored

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

The effect of this order on our business and

the pharmaceutical industry in general is not yet known.

with Environmental Laws

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a significant presence in the pharmaceutical industry.

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

advanced or novel drug delivery systems.

Some of the major pharmaceutical companies have invested and are continuing to invest significant

resources in the development of their own drug delivery systems and technologies and some have invested funds in such specialized drug

delivery companies.

Many of these companies have greater financial and other resources as well as more experience than we do in commercializing

pharmaceutical products.

Certain companies have a track record of success in developing controlled-release drugs.

Significant among these

are, without limitation, Pfizer, Sandoz (a Novartis company), Mylan Laboratories, Inc., Endo Pharmaceuticals, Inc., Teva Pharmaceuticals

Industries Ltd., Amneal Laboratories, Inc., Mallinckrodt, and Aurobindo.

Each of these companies has developed expertise in certain types

of drug delivery systems, although such expertise does not carry over to developing a controlled-release version of all drugs.

Such companies

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

addition, almost all of our competitors have vastly greater resources than we do.

While our product development capabilities and, if

obtained, patent protection may help us to maintain our market position in the field of advanced drug delivery, there can be no assurance

that others will not be able to develop such capabilities or alternative technologies outside the scope of our patents, if any, or that

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

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

incorporating advanced or novel drug delivery systems.

Some of the major pharmaceutical companies have invested and are continuing

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

in such specialized drug delivery companies.

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

experience than we do in commercializing pharmaceutical products.

Certain companies have a track record of success in developing

controlled-release drugs.

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

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

and Aurobindo Pharma USA, Inc.

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

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

Such companies may develop new drug formulations and

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

In addition, almost all of our

competitors have vastly greater resources than we do.

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

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

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

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

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

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Reporting Segments

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

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

marketing approvals were secured via an NDA.

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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.

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

$56.6 million, respectively.

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

million, respectively.

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

to be the chief executive office, for the purposes of making decisions about allocating resources and assessing performance of the Company.

to be the Chief Executive Officer, for the purposes 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 chief operating

decision maker does not review this information by segment.

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

of June 25, 2025, we had 68 full-time employees.

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

What changed 10-K

Item 1. Business