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    Company profile for Bora Pharmaceuticals

    Bora Pharmaceuticals-PSE
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    Bora to Expand Rare Disease Portfolio with Acquisition of Pyros

    26 Oct 2024

    // PRESS RELEASE

    Bora Pharmaceuticals Appoints Division President of CDMO Business

    04 Oct 2024

    // PRESS RELEASE

    Formosa Ships APP13007 To US For Commercialization

    09 Sep 2024

    // PR NEWSWIRE

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    About

    Bora Pharmaceuticals is a premier global contract development and manufacturing organization (CDMO), specializing in formulation development, clinical and commercial manufacturing and packaging of complex oral solid dose, liquid, and semi-solid pharmaceutical products for clinical and commercial uses.
    From cell-line development and formulation to analytical services and clinical cGMP manufacturing, Bora now provides tailored development and manufacturing services to biologics developers. Bora operates nine cGMP manufacturing sites in Asia, Canada, and the United States, and delivers to over 100 markets worldwide.

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    Bora PharmaceuticalsTaiwan Flag
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    Taiwan
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    6F, No 69, Xing'ai Road, Neihu District, Taipei City 114
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    +1 844636-BORA (2672) // +1 616636-BORA (2672)
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    marketing@bora-corp.com
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    https://www.boracdmo.com
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    http://www.youtube.com/@groupbora5676
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    North America facility:
    Bora Pharmaceuticals – North America

    Taiwan facilities:
    Bora Pharmaceuticals – Taoyuan
    Bora Pharmaceuticals – Tainan
    Bora Pharmaceuticals – Zhongli
    Bora Pharmaceuticals – Zhunan
    Bora Biologics – Zhubei

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    CORPORATE CONTENT #SupplierSpotlight

    Ophthalmics

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    Facilities in Taiwan

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    Cell Line Development

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    Outstanding Company of the Year Award at Bio-Asia Taiwan 2023

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    Biologics CDMO

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    Small Molecule CDMO

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    Bora new CMO for Commercial Manufacturing of Phexxi® for Evofem

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    Extrusion-Spheronization for Controlled Release Forms

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    DATA COMPILATION #PharmaFlow

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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    Bora to Expand Rare Disease Portfolio with Acquisition of Pyros
    Bora to Expand Rare Disease Portfolio with Acquisition of Pyros

    26 Oct 2024

    // PRESS RELEASE

    https://bora-corp.com/bora-pharmaceuticals-to-expand-rare-disease-portfolio-with-acquisition-of-us-based-pyros-pharmaceuticals/

    PRESS RELEASE
    26 Oct 2024
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    Bora Pharmaceuticals Appoints Division President of CDMO Business
    Bora Pharmaceuticals Appoints Division President of CDMO Business

    04 Oct 2024

    // PRESS RELEASE

    https://bora-corp.com/bora-appoints-j-d-mowery-as-first-division-president-of-its-cdmo-business/

    PRESS RELEASE
    04 Oct 2024
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    Formosa Ships APP13007 To US For Commercialization
    Formosa Ships APP13007 To US For Commercialization

    09 Sep 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/formosa-pharmaceuticals-makes-first-shipment-of-app13007-clobetasol-propionate-ophthalmic-suspension-0-05-to-the-united-states-for-commercialization-302241470.html

    PR NEWSWIRE
    09 Sep 2024
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    Tanvex Appoints Biopharma Industry Veteran Stephen Lam as CEO
    Tanvex Appoints Biopharma Industry Veteran Stephen Lam as CEO

    05 Sep 2024

    // PRESS RELEASE

    https://bora-corp.com/tanvex-appoints-biopharma-industry-veteran-stephen-lam-as-ceo/

    PRESS RELEASE
    05 Sep 2024
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    Bora Pharma Invests In Tanvex To Expand Global Biomanufacturing Services
    Bora Pharma Invests In Tanvex To Expand Global Biomanufacturing Services

    27 Aug 2024

    // PRESS RELEASE

    https://bora-corp.com/bora-completes-acquisition-of-us-sterile-fill-finish-facility-from-emergent/

    PRESS RELEASE
    27 Aug 2024
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    Bora Completes Acquisition of US Sterile Fill/Finish Facility From Emergent
    Bora Completes Acquisition of US Sterile Fill/Finish Facility From Emergent

    21 Aug 2024

    // PRESS RELEASE

    https://bora-corp.com/bora-completes-acquisition-of-us-sterile-fill-finish-facility-from-emergent/

    PRESS RELEASE
    21 Aug 2024
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    Services

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    Analytical

    Discover their expertise for : Analytical

    Drug Product Manufacturing

    Discover their expertise for : Drug Product Manufacturing

    Packaging

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    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

    KEY SERVICES

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    TOP RANKED SUPPLIER FOR:

    Bora Pharmaceuticals full-view
    In-Vitro Bioequivalence studies
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    Topical Solutions
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    Formulation Development Services for Solution
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    Ophthalmic Formulations
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    Manufacturing Vaccines
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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
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    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2008-12-10

    Bora Pharmaceuticals

    City : Mississauga

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2008-12-10

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    02

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2008-12-10

    Bora Pharmaceuticals

    City : Mississauga

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2008-12-10

    Bora Pharmaceutical

    Product
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    Stock Recap
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    03

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-06-18

    Bora Pharmaceuticals

    City : Miaoli County

    State :

    Country/Area : TW

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-06-18

    Bora Pharmaceutical

    Product
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    04

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-07-16

    Bora Pharmaceuticals

    City : Mississauga

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-07-16

    Bora Pharmaceutical

    Product
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    05

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-08-15

    Bora Pharmaceuticals

    City : Mississauga

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-08-15

    Bora Pharmaceutical

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    06

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-07-26

    Bora Pharmaceuticals

    City : Miaoli County

    State :

    Country/Area : TW

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-07-26

    Bora Pharmaceutical

    Product
    Web Link

    Stock Recap
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    07

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-09-25

    Bora Pharmaceuticals

    City : Mississauga

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-09-25

    Bora Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    08

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-07-26

    Bora Pharmaceuticals

    City : Miaoli County

    State :

    Country/Area : TW

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-07-26

    Bora Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
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    09

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-07-21

    Bora Pharmaceuticals

    City : Mississauga

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-07-21

    Bora Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    10

    FDA Audited

    USA
    arrow
    Antibody Engineering
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-07-24

    Bora Pharmaceuticals

    City : Mississauga

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-07-24

    Bora Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

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