Flutamide | Fermion Oy | Dossiers | Finished Dosage Forms

Fermion has completed first investment for new Mfg capacity for APIs

12 May 2024

// PRFESS RELEASE

Ami Organics inks agreement with Fermion for two additional APIs

19 Dec 2023

// INDIAN PHARMA POST

Fermion has received CEPs for Benserazide HCL and Entacapone

19 Oct 2023

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

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Contract Pharma 2024

Booth #128

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DIGITAL CONTENT

15 CORPORATE CONTENT #SupplierSpotlight, 1 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

media
15 CORPORATE CONTENT #SupplierSpotlight
1 DATA COMPILATION #PharmaFlow
28 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

42 All APIs, 31 USDMF, 22 CEP/COS, 12 JDMF, 11 KDMF, 21 NDC API, 5 VMF, 33 Listed APIs

42 All APIs
31 USDMF
22 CEP/COS
12 JDMF
11 KDMF
21 NDC API
5 VMF
33 Listed APIs

DEVELOPMENTS

36 Drugs in Development

36 Drugs in Development

FINISHED DOSAGE FORMULATIONS

587 FDF Dossiers, 7 FDA Orange Book, 534 Europe, 46 Canada

587 FDF Dossiers
7 FDA Orange Book
534 Europe
46 Canada

INTERMEDIATES

9 ALL Intermediates

9 ALL Intermediates

KEY PRODUCTS

Benserazide Hydrochloride, Dexmedetomidine Hydrochloride, Methotrexate, Nintedanib Esylate

Benserazide Hydrochloride
Dexmedetomidine Hydrochloride
Methotrexate
Nintedanib Esylate

SERVICES

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

pharmaServices
Analytical
- 1 Analytical Method Development
API Manufacturing
Drug Product Manufacturing
API & Drug Product Development
- 3 API Development
Packaging
- 7 Contract Services

KEY SERVICES

API Contract Manufacturing Services, API Micronization Services, Contract Manufacturing for Cytotoxic APIs, Clinical Supply of APIs, CMO for Hormonal Gels & Solutions, Controlled Substance API Manufacturing

API Contract Manufacturing Services
API Micronization Services
Contract Manufacturing for Cytotoxic APIs
Clinical Supply of APIs
CMO for Hormonal Gels & Solutions
Controlled Substance API Manufacturing

INSPECTIONS & REGISTRATIONS

20 FDA, 9 EDQM, 4 GDUFA

inspections
20 FDA
9 EDQM
4 GDUFA

With Fermion, start the journey of your innovative API.

About

Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & Formulations. API portfolio consists of >30 generic APIs & >10 NCEs & 2 mfg. sites as well as R&D facilities are all located in Finland. Fermion has invested & expanded capabilities in the production of HPAPIs. Drug product CMO services include hormonal & non-hormonal semi-solids, cytotoxic oral solids & packaging. We have 3 mfg. sites & one packaging center for drug products at Orion.

CPhI Worldwide, MilanCPhI Worldwide, Milan

Industry Trade Show

Booth #2B26

08-10 October, 2024

Fiera Milano, Italy
Contract Pharma 2024Contract Pharma 2024

Industry Trade Show

Booth #128

26-27 September, 2024

Hyatt Regency New Brunswick, NJ
Bio-Europe 2024Bio-Europe 2024

Industry Trade Show

Attending

04-06 November, 2024

Stockholm, Sweden

CONTACT DETAILS

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Country

Finland

Address

Koivu-Mankkaan tie 6 A, FI-02200 Espoo

Telephone

+358 104261

fermionSales@fermion.fi

Website

https://www.fermion.fi/

https://fi.linkedin.com/company/fermion-oy

Digital content

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CORPORATE CONTENT #SupplierSpotlight

Product List 2024

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Corporate Presentation

GMP Certificate 2023

Japan Accreditation Certificate for Oulu Plant

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Japan Accreditation Certificate for Hanko Plant

List of Inspections

Company Introduction

Oulu Unit

Quality & On-Time Delivery

Turku Unit

Hanko Unit 4 Virtual Tour

Delivering Consistent API Quality

Fermion R&D

Hanko Unit 4

HPAPI Solutions

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.