Axplora, Farmabios, Pharmazell and Novasep DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

Axplora’s Chasse-sur-Rhône CDMO Site in France Passes Inspection

04 Jun 2025

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Axplora Launches Payload Manufacturing Workshop in France

04 Mar 2025

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Axplora Boosts GLP-1 Manufacturing with €50M Investment in France

13 Feb 2025

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DATA COMPILATION
#PharmaFlow

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DIGITAL CONTENT

1 Interview #SpeakPharma, 1 Vlog #PharmaReel, 16 Corporate Content #SupplierSpotlight, 2 Data Compilation #PharmaFlow, 124 News #PharmaBuzz

media
1 Interview #SpeakPharma
1 Vlog #PharmaReel
16 Corporate Content #SupplierSpotlight
2 Data Compilation #PharmaFlow
124 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

178 All APIs, 58 USDMF, 41 CEP/COS, 24 JDMF, 26 KDMF, 113 NDC API, 97 Listed APIs

178 All APIs
58 USDMF
41 CEP/COS
24 JDMF
26 KDMF
113 NDC API
97 Listed APIs

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

1 All Intermediates

1 All Intermediates

KEY PRODUCTS

Acetylcysteine, Balsalazide Disodium, Betahistine Dihydrochloride, Betahistine Dimesilate, Carbocisteine, Carbocysteine Lysine, Chenodeoxycholic Acid, Cholic Acid, Lysine, Lysine Acetate, Lysine Hydrochloride, Mesalazine, Methylene Blue, Propafenone Hydrochloride, Ursodeoxycholic Acid, Zavegepant HCl

Acetylcysteine
Balsalazide Disodium
Betahistine Dihydrochloride
Betahistine Dimesilate
Carbocisteine
Carbocysteine Lysine
Chenodeoxycholic Acid
Cholic Acid
Lysine
Lysine Acetate
Lysine Hydrochloride
Mesalazine
Methylene Blue
Propafenone Hydrochloride
Ursodeoxycholic Acid
Zavegepant HCl

SERVICES

API Manufacturing, API & Drug Product Development

KEY SERVICES

Complex API Development Services, CDMO for Small Molecule APIs, API Custom Synthesis, Hazardous Chemistry, Flow Chemistry, Industrial Chromatography, Contract Development & Manufacturing for ADCs

Complex API Development Services
CDMO for Small Molecule APIs
API Custom Synthesis
Hazardous Chemistry
Flow Chemistry
Industrial Chromatography
Contract Development & Manufacturing for ADCs

EXCIPIENTS

1 All Excipients, 1 NDC API

excipientPortfolio
1 All Excipients
1 NDC API

INSPECTIONS & REGISTRATIONS

30 FDA, 44 EDQM, 1 WHO-GMP, 5 GDUFA

inspections
30 FDA
44 EDQM
1 WHO-GMP
5 GDUFA

Axplora is your partner of choice for complex APIs.

About

Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.

CPhI ChinaCPhI China

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24-26 June, 2025

SNIEC, Shanghai, China
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23-26 June, 2025

Pittsburgh, PA
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29 September-02 October, 2025

Philadelphia, PA, United States

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Germany

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Headquarters, HochstraB-Süd 7, 83064 Raubling

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Digital content

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INTERVIEW #SpeakPharma

"Axplora’s leading position in ADCs and how it is well-placed to serve the burgeoning GLP1 market"

This week, SpeakPharma interviews Martin Meeson, CEO of Axplora, a leading and reliable API manufacturing partner to some of the world’s biggest pharma and biotech companies. Meeson discusses Axplora’s expansion in the antibody-drug-conjugate (ADC) space and how it is well-placed to serve the exciting market for glucagon-like peptide 1 (GLP-1) drugs with its industrial footprint and purification technologies across several sites. 🔑 HIGHLIGHTS// API manufacturing partner to some of the world’s biggest pharma and biotech companies As a leader in the pharmaceutical industry, what inspired you to join Axplora? And, what do you consider the most rewarding aspect of your role as its CEO? When you look at Axplora as the custodian of strong brands like Farmabios, Pharmazell and Novasep you cannot help but be intrigued by what such breadth of offering and depth of technical expertise can achieve. Well, I was certainly intrigued! As a leader in the pharma space, the opportunity to guide an organization with several decades of experience is inspiring for me. For example, our site in Leverkusen was founded over 150 years ago by Alfred Nobel. With every meeting and site visit, I get increasingly impressed by the capabilities of the people that I meet. Now, it is my job to make sure that these capabilities are given the best opportunity to serve. In this sector, we have the privilege of working with our partners to supply and develop medicines that have such a positive impact on people’s lives. This for me is the most rewarding thing that we do. Sometimes the work that we do can seem a little far away from the patient. I always take time to remind myself, my staff, and hopefully also your readers of what we are doing and how our work impacts others. 🔑 HIGHLIGHTS// strong brands like Farmabios, Pharmazell and Novasep / positive impact on people’s lives How have recent industry developments influenced both API manufacturing and CDMO sectors, and what specific strategies has Axplora implemented to adapt to these changing market dynamics while maintaining its commitment to quality and innovation? As a CDMO, when you partner with us, there is always a focus on reliable supply, and we are still haunted by the challenges all of us faced during the pandemic. At Axplora, we have implemented numerous initiatives to increase the robustness of supply, particularly in looking at advances in sourcing and horizontal integration both within and across our network. At the same time, we have a strong focus on the impact that we are having on the planet and Axplora’s work in this area is tremendous — from increasing the amount and efficacy of waste management, notably the current programs around solvent recovery and recycling, to implementing more environment-friendly technologies such as electrochemistry. I am particularly excited by the cutting-edge work on moving to completely new processes that are water-based rather than solvent-based, creating a step change in impact for us and our partners. In addition, as a CDMO you have to constantly look at where your services fit within evolving markets. Axplora’s expansion in the ADC sector is an excellent example of tracking and investing in emerging technologies. Of note also is the current demand for GLP-1 medicines, and Axplora is well-placed to serve this exciting market with our industrial footprint in small molecules and purification technologies across several sites in our network. 🔑 HIGHLIGHTS// increase the robustness of supply / efficient waste management programs and environment-friendly technologies Can you discuss any recent advancement or breakthrough in API manufacturing or CDMO services at Axplora that have contributed to the company’s success? Our investment in ADC expansion is a key strength. Our Novasep business has some of the world’s leading capabilities in API manufacturing and purification. It is known worldwide for these capabilities. With increasing demand for GLP-1 drugs and the amazing impact they are having on patients globally, we are ready to support this growth across our extensive network. The race to oral dose medicines in this space is particularly exciting, and Axplora is looking forward to treating the vast patient population in diabetes and obesity. 🔑 HIGHLIGHTS// expansion in the ADC sector / treat the vast patient population in diabetes and obesity Looking ahead, what are some of the trends or developments you foresee in API manufacturing and CDMO services, and how is Axplora preparing to stay ahead of the curve in this ever-evolving pharmaceutical landscape? Whilst the landscape is evolving rapidly, regulations are not necessarily able to keep pace with the development of new molecules. The pandemic revealed that things can move more quickly. When I look at the challenging new regulation in adjacent spaces like cell therapy, I wonder how that pace can be applied to our sectors. To that end, you have to remain agile and responsive to customer needs. We have to ensure we invest to grow our capacity in the right areas. Our recent investments in Farmabios in Gropello Cairoli (Italy) to support our thriving steroids business and in Pharmazell in Vizag (India) to advance our specialty business are clear indications of how we can do this very successfully. It would be easier if I could point to just one thing that we are doing, but that is not how we win. The only way to stay ahead is by making a myriad of large and small adjustments and evolutions and that is where the Axplora group excels. Finally, one element I should mention is that we are part of a global supply chain. Therefore, our broad network stands ready to supply medicines to multiple geographies. Our investments reflect our worldwide customer base and ambitions. We are here to serve our partners and their patients. 🔑 HIGHLIGHTS// recent investments in Farmabios in Italy and Pharmazell in India / ready to supply medicines to multiple geographies

Impressions: 3033

VLOG #PharmaReel

Pioneering Innovative API Manufacturing Solutions

Pioneer of world-class API manufacturing solutions with ADC, steroids and flow chemistry expertise, empowering 900+ customers.

Impressions: 1580

CORPORATE CONTENT #SupplierSpotlight

Product List 2024

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Corporate Presentation

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CDMO Services for Pharmaceuticals 2024

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CDMO Services for ADCs 2024

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Finorga GMP Certificate 2024

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Farmabios GMP Certificate 2024

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PharmaZell GMP Certificate 2023

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Novasep GMP Certificate 2022

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Seripharm GMP Certificate 2021

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Martin Meeson Appointed as CEO of Axplora

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PharmaZell & Novasep Announce the Closing of their Merger.

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In Negotiations with Novasep for Complex Small Molecules & ADCs

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CPHI Barcelona 2023: CCO Arul Ramadurai

CDMO Leadership Awards 2023-Arul Ramadurai Interview

Three Legacies, One Company 2022

DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025.

Impressions: 3258

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.

Impressions: 3883