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    Company profile for TWi Pharmaceuticals

    European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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    Guizhou Utide Biotechnology Co., Ltd. - Specialized GMP manufacturing for next-generation GLP-1 peptide APIs.

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    About

    TWi Pharmaceuticals, Inc. (TWi) is a technology-based special pharmaceutical company focusing on the development and commercialization of "High Barrier Generics" drugs primarily for United States. Unlike the common generic drugs, developing high barrier generic drugs require a full array of expertise, including advanced scientific research, process development, patent analysis, regulatory compliances, and market and competitio...
    TWi Pharmaceuticals, Inc. (TWi) is a technology-based special pharmaceutical company focusing on the development and commercialization of "High Barrier Generics" drugs primarily for United States. Unlike the common generic drugs, developing high barrier generic drugs require a full array of expertise, including advanced scientific research, process development, patent analysis, regulatory compliances, and market and competition analysis. TWi focuses on the development of the following two categories of high barrier generic drugs.

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    CONTACT DETAILS

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    TWi PharmaceuticalsTaiwan Flag
    Country
    Country
    Taiwan
    Address
    Address
    4F, No. 41, Lane 221, Kang Chien Rd., Nei Hu Dist. Taipei 114
    Telephone
    Telephone
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.twipharma.com/
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    Twitter

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    Events

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    NEWS #PharmaBuzz

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    Twi Pharms’ Generics Cyclosporine Receives Approval in US
    Twi Pharms’ Generics Cyclosporine Receives Approval in US

    21 Jan 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209064

    FDA
    21 Jan 2026
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    CVS Sues Takeda Over 'Pay-For-Delay' Scheme
    CVS Sues Takeda Over 'Pay-For-Delay' Scheme

    10 Sep 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/takeda-faces-another-pay-delay-antitrust-lawsuit-one-cvs-over-heartburn-drug-dexilant

    FIERCE PHARMA
    10 Sep 2025
    Share Share
    Strides Pharma subsidiary receives USFDA approval for 60 mg Fluoxetine tablets
    Strides Pharma subsidiary receives USFDA approval for 60 mg Fluoxetine tablets

    18 Sep 2024

    // EXPRESSPHARMA

    https://www.expresspharma.in/strides-pharma-subsidiary-receives-usfda-approval-for-60-mg-fluoxetine-tablets/

    EXPRESSPHARMA
    18 Sep 2024
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    TWi Pharma's Generic Dicyclomine Hydrochloride Receives Approval in the U.S.
    TWi Pharma's Generic Dicyclomine Hydrochloride Receives Approval in the U.S.

    01 Jun 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216782

    FDA
    01 Jun 2023
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    TWi's Generic Dicyclomine Hydrochloride Receives Approval in the U.S.
    TWi's Generic Dicyclomine Hydrochloride Receives Approval in the U.S.

    27 Dec 2022

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217054

    FDA
    27 Dec 2022
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    TWi's Generic Dexlansoprazole Receives Approval in the U.S.
    TWi's Generic Dexlansoprazole Receives Approval in the U.S.

    16 Sep 2022

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202666

    FDA
    16 Sep 2022
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    Drugs in Development

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    Bora Acquires Six US Brand Product Licenses, Rights

    Details:

    Through the acquisition, Bora will utilize Almatica's generic pharmaceutical products, including Zestril (lisinopril), an oral tablet used for treating hypertension, for commercialization purposes.


    Lead Product(s): Lisinopril

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Zestril

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Recipient: ALMATICA PHARMA INC

    Deal Size: $38.5 million Upfront Cash: Undisclosed

    Deal Type: Acquisition August 18, 2023

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    Lead Product(s) : Lisinopril

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Recipient : ALMATICA PHARMA INC

    Deal Size : $38.5 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Bora Acquires Six US Brand Product Licenses, Rights

    Details : Through the acquisition, Bora will utilize Almatica's generic pharmaceutical products, including Zestril (lisinopril), an oral tablet used for treating hypertension, for commercialization purposes.

    Product Name : Zestril

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    August 18, 2023

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    REF. STANDARDS & IMPURITIES

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    FDA

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-07

    TWi Pharmaceuticals

    City : Taoyuan City

    State :

    Country/Area : Taiwan

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-07

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-07-13

    TWi Pharmaceuticals

    City : Taoyuan City

    State :

    Country/Area : Taiwan

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-07-13

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    District Decision : No Action Indicated

    Inspection End Date : 2014-05-15

    TWi Pharmaceuticals

    City : Taoyuan City

    State :

    Country/Area : Taiwan

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-15

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    District Decision : No Action Indicated

    Inspection End Date : 2014-05-12

    TWi Pharmaceuticals

    City : Taipei

    State :

    Country/Area : Taiwan

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-12

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    District Decision : No Action Indicated

    Inspection End Date : 2012-09-14

    TWi Pharmaceuticals

    City : Taoyuan City

    State :

    Country/Area : Taiwan

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-09-14

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    GDUFA

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    Paid in : 2019

    TWi Pharmaceuticals

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : TWi Pharmaceuticals, Inc. Zhon...

    Business Address : 3-1, Ziqiang 4th Rd. Taoyuan...

    FEI Number : 3005674517

    Country : Taiwan

    Paid in : 2019

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