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    Company profile for Towa Pharmaceutical

    Towa Pharmaceutical-PSE
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    Towa Pharma Integrated Report 2025 has been released

    22 Dec 2025

    // PRESS RELEASE

    Towa FY2025(2nd Q) Supplementary Material of Financial Results

    10 Nov 2025

    // PRESS RELEASE

    Towa Consolidated FYR for the Six Months Ended September 30, 2025

    11 Oct 2025

    // PRESS RELEASE

    DATA COMPILATION
    #PharmaFlow

    Towa Pharmaceutical

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    Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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    About

    Towa being a pharmaceutical company specialized in generic drugs, has been dedicated to research and development, production, and marketing of generic drugs for many years. Generic drugs have increasingly played a very important role in this aged society, because they are economically affordable for patients and help to curtail the financial burden of the government. In addition to promoting stable supply, quality assurance, and information provision about generic drugs, Towa focuses on research and development of value-added formulations that are easily taken by patients and handled by medical professionals.

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    Towa Pharmaceuticaljapan Flag
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    Japan
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    2-11, Shinbashi-cho, Kadoma, Osaka 571-8580
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    +81 0669009100
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    enquiries@pharmacompass.com
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    https://www.towayakuhin.co.jp/english/
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    CORPORATE CONTENT #SupplierSpotlight

    Corporate Presentation

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    GMP Certificate 2023

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    DATA COMPILATION #PharmaFlow

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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    21 Nov 2024
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    NEWS #PharmaBuzz

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    Towa Pharma Integrated Report 2025 has been released
    Towa Pharma Integrated Report 2025 has been released

    22 Dec 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/assets/2025en.pdf

    PRESS RELEASE
    22 Dec 2025
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    Towa FY2025(2nd Q) Supplementary Material of Financial Results
    Towa FY2025(2nd Q) Supplementary Material of Financial Results

    10 Nov 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/assets/slide70b.pdf

    PRESS RELEASE
    10 Nov 2025
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    Towa Consolidated FYR for the Six Months Ended September 30, 2025
    Towa Consolidated FYR for the Six Months Ended September 30, 2025

    11 Oct 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/assets/result70b.pdf

    PRESS RELEASE
    11 Oct 2025
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    Towa Pharmaceu Launched a special website
    Towa Pharmaceu Launched a special website "NOx ThinkTank Project

    06 Oct 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/nox-thinktank/

    PRESS RELEASE
    06 Oct 2025
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    Towa's Research paper on Cut nitroso-atomoxetine contamination
    Towa's Research paper on Cut nitroso-atomoxetine contamination

    22 Aug 2025

    // PUBS ACS

    https://pubs.acs.org/doi/10.1021/acs.oprd.5c00182

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    22 Aug 2025
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    Notice of Partial Revision of Basic Policy for the Development
    Notice of Partial Revision of Basic Policy for the Development

    17 Mar 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/

    PRESS RELEASE
    17 Mar 2025
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    Drugs in Development

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    Breckenridge Launches Generic Everolimus Tablets, 1mg

    Details:

    Everolimus, a miscellaneous product targeting FK506-binding protein 1A, shows promise in treating organ rejection in adult patients undergoing kidney and liver transplantation.


    Lead Product(s): Everolimus

    Therapeutic Area: Immunology Brand Name: Zortress-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Natco Pharma

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 30, 2025

    Breckenridge Pharmaceutical

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    Lead Product(s) : Everolimus

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Natco Pharma

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Breckenridge Launches Generic Everolimus Tablets, 1mg

    Details : Everolimus, a miscellaneous product targeting FK506-binding protein 1A, shows promise in treating organ rejection in adult patients undergoing kidney and liver transplantation.

    Product Name : Zortress-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 30, 2025

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    Breckenridge Gets FDA Nod For Dehydrated Alcohol Injection, Ablysinol Generic

    Details:

    Ablysinol-Generic is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy.


    Lead Product(s): Ethanol

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Ablysinol-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 24, 2025

    Breckenridge Pharmaceutical

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    Lead Product(s) : Ethanol

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Breckenridge Gets FDA Nod For Dehydrated Alcohol Injection, Ablysinol Generic

    Details : Ablysinol-Generic is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy.

    Product Name : Ablysinol-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 24, 2025

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    Senores Pharma Gains After Arm Inks Pact to Acquire Roflumilast Tablets

    Details:

    Senores acquire the USFDA-approved abbreviated new drug application for Roflumilast, indicated as a treatment to reduce the risk of COPD exacerbations, from Breckenridge.


    Lead Product(s): Roflumilast

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Roflumilast-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Senores Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition February 21, 2025

    Breckenridge Pharmaceutical

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    Lead Product(s) : Roflumilast

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Senores Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Senores Pharma Gains After Arm Inks Pact to Acquire Roflumilast Tablets

    Details : Senores acquire the USFDA-approved abbreviated new drug application for Roflumilast, indicated as a treatment to reduce the risk of COPD exacerbations, from Breckenridge.

    Product Name : Roflumilast-Generic

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    February 21, 2025

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    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details:

    MefoVil (vildagliptin & metformin hydrochloride) is an antibiotic drug, which is indicated for the treatment of type 2 diabetes mellitus.


    Lead Product(s): Vildagliptin,Metformin

    Therapeutic Area: Endocrinology Brand Name: MefoVil

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 17, 2025

    Towa Pharmaceutical

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    Lead Product(s) : Vildagliptin,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details : MefoVil (vildagliptin & metformin hydrochloride) is an antibiotic drug, which is indicated for the treatment of type 2 diabetes mellitus.

    Product Name : MefoVil

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    February 17, 2025

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    Breckenridge Gains FDA Nod for Everolimus, Afinitor Disperz Generic

    Details:

    Afinitor Disperz (everolimus) is an mTOR inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of tuberous sclerosis complex.


    Lead Product(s): Everolimus

    Therapeutic Area: Rare Diseases and Disorders Brand Name: Afinitor Disperz-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 29, 2025

    Breckenridge Pharmaceutical

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    Lead Product(s) : Everolimus

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Breckenridge Gains FDA Nod for Everolimus, Afinitor Disperz Generic

    Details : Afinitor Disperz (everolimus) is an mTOR inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of tuberous sclerosis complex.

    Product Name : Afinitor Disperz-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 29, 2025

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    Breckenridge Announces final FDA Approval for Methadone Hydrochloride Multi-Dose Injection

    Details:

    Methadone HCl Multi-Dose Vial is a Mu opioid receptor agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic.


    Lead Product(s): Methadone Hydrochloride

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 18, 2024

    Breckenridge Pharmaceutical

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    Lead Product(s) : Methadone Hydrochloride

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Breckenridge Announces final FDA Approval for Methadone Hydrochloride Multi-Dose Injection

    Details : Methadone HCl Multi-Dose Vial is a Mu opioid receptor agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 18, 2024

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    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details:

    Rivaroxaban OD Tablets (rivaroxaban) is an oral factor Xa inhibitor, which is indicated for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.


    Lead Product(s): Rivaroxaban

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Rivaroxaban OD Tablets

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 15, 2024

    Towa Pharmaceutical

    07

    Towa Pharmaceutical

    Japan
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Lead Product(s) : Rivaroxaban

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details : Rivaroxaban OD Tablets (rivaroxaban) is an oral factor Xa inhibitor, which is indicated for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.

    Product Name : Rivaroxaban OD Tablets

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 15, 2024

    Towa Pharmaceutical

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    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details:

    Lenalidomide Capsules (lenalidomide hydrate) is a thalidomide analogue indicated for the treatment of adult patients with multiple myeloma.


    Lead Product(s): Lenalidomide

    Therapeutic Area: Oncology Brand Name: Lenalidomide Capsules

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 15, 2024

    Towa Pharmaceutical

    08

    Towa Pharmaceutical

    Japan
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Lead Product(s) : Lenalidomide

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details : Lenalidomide Capsules (lenalidomide hydrate) is a thalidomide analogue indicated for the treatment of adult patients with multiple myeloma.

    Product Name : Lenalidomide Capsules

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 15, 2024

    Towa Pharmaceutical

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    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details:

    Loxoprofen Sodium is a generic version of loxonin tape, which is indicated for the treatment of rheumatoid arthritis and osteoarthritis.


    Lead Product(s): Loxoprofen Sodium

    Therapeutic Area: Musculoskeletal Brand Name: Loxoprofen Sodium Tape

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 15, 2024

    Towa Pharmaceutical

    09

    Towa Pharmaceutical

    Japan
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    BIO Partnering at JPM
    Not Confirmed
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Lead Product(s) : Loxoprofen Sodium

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details : Loxoprofen Sodium is a generic version of loxonin tape, which is indicated for the treatment of rheumatoid arthritis and osteoarthritis.

    Product Name : Loxoprofen Sodium Tape

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 15, 2024

    Towa Pharmaceutical

    Stock Recap
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details:

    Vildagliptin Tablets (vildagliptin) is a DPP-4 inhibitor, small molecule drug candidate, which is indicated for the treatment of type 2 diabetes mellitus.


    Lead Product(s): Vildagliptin

    Therapeutic Area: Endocrinology Brand Name: Vildagliptin Tablets

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 15, 2024

    Towa Pharmaceutical

    10

    Towa Pharmaceutical

    Japan
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    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Lead Product(s) : Vildagliptin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Acquired Approval for Manufacturing and Marketing Generic Drugs

    Details : Vildagliptin Tablets (vildagliptin) is a DPP-4 inhibitor, small molecule drug candidate, which is indicated for the treatment of type 2 diabetes mellitus.

    Product Name : Vildagliptin Tablets

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 15, 2024

    Towa Pharmaceutical

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