Bora Pharmaceuticals DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

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

DATA COMPILATION
#PharmaFlow

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Bio-Europe 2024

Attending

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DIGITAL CONTENT

1 VLOG #PharmaReel, 13 CORPORATE CONTENT #SupplierSpotlight, 1 DATA COMPILATION #PharmaFlow, 69 NEWS #PharmaBuzz

media
1 VLOG #PharmaReel
13 CORPORATE CONTENT #SupplierSpotlight
1 DATA COMPILATION #PharmaFlow
69 NEWS #PharmaBuzz

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

SERVICES

Analytical, Drug Product Manufacturing, Packaging, API & Drug Product Development

pharmaServices
Analytical
- 1 BioAnalytical Services
- 1 Analytical Method Development
Drug Product Manufacturing
Packaging
- 3 Contract Services
API & Drug Product Development
- 9 Formulation Development

KEY SERVICES

Nasal Spray Contract Manufacturing, Liquid Formulation Development Services, Ophthalmic Contract Manufacturing, Biologics Analytical Development & cGMP Mfg., CDMO for Ophthalmic Formulations, Development of Semi-Solid Dosage Forms, CDMO for Biologics

Nasal Spray Contract Manufacturing
Liquid Formulation Development Services
Ophthalmic Contract Manufacturing
Biologics Analytical Development & cGMP Mfg.
CDMO for Ophthalmic Formulations
Development of Semi-Solid Dosage Forms
CDMO for Biologics

INSPECTIONS & REGISTRATIONS

15 FDA, 2 GDUFA, 1 Others

inspections
15 FDA
2 GDUFA
1 Others

Bora Pharmaceuticals- Making success more certain.

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.

CPhI India 2024CPhI India 2024

Industry Trade Show

Not Confirmed

26-28 November, 2024

India Expo Centre, Greater Noida
Bio-Europe 2024Bio-Europe 2024

Industry Trade Show

Attending

04-06 November, 2024

Stockholm, Sweden
PackExpoPackExpo

Industry Trade Show

Not Confirmed

03-06 November, 2024

Chicago, Illinois, USA

CONTACT DETAILS

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Country

Taiwan

Address

6F, No 69, Xing'ai Road, Neihu District, Taipei City 114

Telephone

+1 844636-BORA (2672) // +1 616636-BORA (2672)

marketing@bora-corp.com

Website

https://www.boracdmo.com

https://in.linkedin.com/company/borapharmaceuticals

YouTube

http://www.youtube.com/@groupbora5676

Digital content

Explore the latest content creation from this company

VLOG #PharmaReel

Specialized in Formulation Development, Clinical & Commercial Mfg

CORPORATE CONTENT #SupplierSpotlight

Ophthalmics

Facilities in Taiwan

Cell Line Development

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

Biologics CDMO

Small Molecule CDMO

Bora new CMO for Commercial Manufacturing of Phexxi® for Evofem

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Extrusion-Spheronization for Controlled Release Forms

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Mississauga Facility

Bora VR Facility Tour

Bora's New Journey at Mississauga

Production Area at Bora Mississauga Site

DATA COMPILATION #PharmaFlow

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.