Company profile for Bora Pharmaceuticals

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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.

CONTACT DETAILS

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Country
Country
Taiwan
Address
Address
6F, No 69, Xing'ai Road, Neihu District, Taipei City 114
Telephone
Telephone
+1 844636-BORA (2672) // +1 616636-BORA (2672)
Twitter
Twitter
Contact Info
Others

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

    https://www.pharmacompass.com/pdf/party/content/bora-pharmaceuticals-party-content-78018.pdf

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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
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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08 Aug 2024

NEWS #PharmaBuzz

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

PRESS RELEASE
26 Oct 2024

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

PRESS RELEASE
04 Oct 2024

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

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

PRESS RELEASE
05 Sep 2024

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

PRESS RELEASE
27 Aug 2024

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

PRESS RELEASE
21 Aug 2024

Drugs in Development

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Details:

Through the acquisition of US-based Pyros, Bora will expand his pipelines by adding some candidates such as Vigafyde (vigabatrin), which is indicated for the treatment of infantile spasms.


Lead Product(s): Vigabatrin

Therapeutic Area: Neurology Brand Name: Vigafyde

Study Phase: ApprovedProduct Type: Small molecule

Recipient: Pyros Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition October 25, 2024

Bora Pharmaceutical

01

Medlab Asia & Asia Health
Not Confirmed

Lead Product(s) : Vigabatrin

Therapeutic Area : Neurology

Highest Development Status : Approved

Recipient : Pyros Pharmaceuticals

Deal Size : Undisclosed

Deal Type : Acquisition

Details : Through the acquisition of US-based Pyros, Bora will expand his pipelines by adding some candidates such as Vigafyde (vigabatrin), which is indicated for the treatment of infantile spasms.

Brand Name : Vigafyde

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 25, 2024

Bora Pharmaceutical

Details:

Through the acquisition, Bora will commercialize Amantadine HCl-Generic, which is an NMDA receptor inhibitor. It is indicated for the treatment of influenza A infections and Parkinsonism.


Lead Product(s): Amantadine Hydrochloride

Therapeutic Area: Infections and Infectious Diseases Brand Name: Amantadine HCl-Generic

Study Phase: ApprovedProduct Type: Small molecule

Recipient: Upsher-Smith Laboratories

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition April 01, 2024

Bora Pharmaceutical

02

Medlab Asia & Asia Health
Not Confirmed

Lead Product(s) : Amantadine Hydrochloride

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Recipient : Upsher-Smith Laboratories

Deal Size : Undisclosed

Deal Type : Acquisition

Details : Through the acquisition, Bora will commercialize Amantadine HCl-Generic, which is an NMDA receptor inhibitor. It is indicated for the treatment of influenza A infections and Parkinsonism.

Brand Name : Amantadine HCl-Generic

Molecule Type : Small molecule

Upfront Cash : Undisclosed

April 01, 2024

Bora Pharmaceutical

Details:

Bora acquires Upsher-Smith’s product portfolio, including Amantadine hydrochloride for treating influenza A virus infections.


Lead Product(s): Amantadine Hydrochloride

Therapeutic Area: Infections and Infectious Diseases Brand Name: Amantadine HCl-Generic

Study Phase: ApprovedProduct Type: Small molecule

Recipient: Upsher-Smith Laboratories

Deal Size: $210.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition January 18, 2024

Bora Pharmaceutical

03

Medlab Asia & Asia Health
Not Confirmed

Lead Product(s) : Amantadine Hydrochloride

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Recipient : Upsher-Smith Laboratories

Deal Size : $210.0 million

Deal Type : Acquisition

Details : Bora acquires Upsher-Smith’s product portfolio, including Amantadine hydrochloride for treating influenza A virus infections.

Brand Name : Amantadine HCl-Generic

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 18, 2024

Bora Pharmaceutical

Details:

Under the partnership, Bora will manufacture and commercialize a range of oral dosage form drugs (OSD), including CT-G20, a hypertrophic cardiomyopathy treatment candidate, across the APAC region.


Lead Product(s): CT-G20

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: CT-G20

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Celltrion

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership April 06, 2023

Bora Pharmaceutical

04

Medlab Asia & Asia Health
Not Confirmed

Lead Product(s) : CT-G20

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Celltrion

Deal Size : Undisclosed

Deal Type : Partnership

Details : Under the partnership, Bora will manufacture and commercialize a range of oral dosage form drugs (OSD), including CT-G20, a hypertrophic cardiomyopathy treatment candidate, across the APAC region.

Brand Name : CT-G20

Molecule Type : Small molecule

Upfront Cash : Undisclosed

April 06, 2023

Bora Pharmaceutical

Details:

CVM-1118 (foslinanib) is a new small molecule chemical entity and a potential anti-cancer agent in numerous human cancer cell lines with strong anti-cancer activity, high safety margin, and multiple mechanisms of actions in targeting cancer-specific factors.


Lead Product(s): Foslinanib,Sorafenib

Therapeutic Area: Oncology Brand Name: CVM-1118

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: TaiRx

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership September 27, 2022

Bora Pharmaceutical

05

Medlab Asia & Asia Health
Not Confirmed

Lead Product(s) : Foslinanib,Sorafenib

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : TaiRx

Deal Size : Undisclosed

Deal Type : Partnership

Details : CVM-1118 (foslinanib) is a new small molecule chemical entity and a potential anti-cancer agent in numerous human cancer cell lines with strong anti-cancer activity, high safety margin, and multiple mechanisms of actions in targeting cancer-specific fact...

Brand Name : CVM-1118

Molecule Type : Small molecule

Upfront Cash : Undisclosed

September 27, 2022

Bora Pharmaceutical

Details:

Initially, Bora will manufacture Phexxi for nations currently considering formal regulatory approval of Phexxi (L-lactic Acid), for the prevention of pregnancy, including Mexico and Nigeria.


Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Phexxi

Study Phase: ApprovedProduct Type: Small molecule

Recipient: Evofem Biosciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership May 10, 2022

Bora Pharmaceutical

06

Medlab Asia & Asia Health
Not Confirmed

Lead Product(s) : L-Lactic Acid,Citric Acid,Potassium Bitartrate

Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

Highest Development Status : Approved

Recipient : Evofem Biosciences

Deal Size : Undisclosed

Deal Type : Partnership

Details : Initially, Bora will manufacture Phexxi for nations currently considering formal regulatory approval of Phexxi (L-lactic Acid), for the prevention of pregnancy, including Mexico and Nigeria.

Brand Name : Phexxi

Molecule Type : Small molecule

Upfront Cash : Undisclosed

May 10, 2022

Bora Pharmaceutical

Details:

Upon PMDA’s approval, Bora will be the commercial manufacturing site for the generic product production. Bora Pharmaceuticals’ sites already have an excellent track record with many regulatory agencies around the world.


Lead Product(s): Undisclosed

Therapeutic Area: Technology Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Undisclosed

Recipient: Kyowa Pharmaceutical Industry

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership August 05, 2021

Bora Pharmaceutical

07

Medlab Asia & Asia Health
Not Confirmed

Lead Product(s) : Undisclosed

Therapeutic Area : Technology

Highest Development Status : Undisclosed

Recipient : Kyowa Pharmaceutical Industry

Deal Size : Undisclosed

Deal Type : Partnership

Details : Upon PMDA’s approval, Bora will be the commercial manufacturing site for the generic product production. Bora Pharmaceuticals’ sites already have an excellent track record with many regulatory agencies around the world.

Brand Name : Undisclosed

Molecule Type : Undisclosed

Upfront Cash : Undisclosed

August 05, 2021

Bora Pharmaceutical
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Services

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Analytical

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Drug Product Manufacturing

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Packaging

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API & Drug Product Development

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KEY SERVICES

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TOP RANKED SUPPLIER FOR:

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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Multidose Eye Drops Manufacturing
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Nasal Care Products Range
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Inspected

RoW

Inspection : Health Canada

About the Company : Bora Pharmaceuticals is a premier global contract development and manufacturing organization (CDMO),...

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.

Country : Taiwan

Bora Pharmaceutical

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