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Aenova Unveils Sustainability Strategy For Responsible Future

09 Oct 2025

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10 Sep 2025

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Aenova Among Top German Mid-Sized Pharma Companies

21 Aug 2025

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Aenova is a leading CDMO in the global pharmaceutical industry. With operations in Europe and the US, services span from early phase development to commercial manufacturing for all common dosage forms from solids to sterile injectables. Specialty technologies include HPAPI, micro-dosing, modified release, organic granulation, particulate systems, lipid-based systems, hot melt extrusion or spray drying for poorly soluble compounds. Excellence and Reliability are core Aenova values, reflected through ample capacities, backup sourcing within the group, and ongoing capital investments, resulting in strong and enduring client partnerships.

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Aenova Capabilities

Gummies: A Modern Dosage Solution

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Capsule Low-Dosing Technology to Accelerate Time-to-Market

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Accelerating Poorly Soluble Drug Development with QbD

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CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

The contract development and manufacturing organization (CDMO) sector has emerged as a key partner in new drug development. This was evident from the strategic investments, partnerships, and expansions witnessed in the third quarter (Q3) of 2025. Several CDMOs, such as Cohance Lifesciences, Fermion Oy, Axplora, AGC Pharma Chemicals invested in new projects. Others, including Veranova, Aenova, and Biosynth, expanded capacities, while Ofichem strengthened its footprint with the acquisition of Avivia BV. CDMOs like Fareva, Evonik, and Samsung Biologics forged strategic partnerships for growth. During Q3, the sector continued to adopt artificial intelligence (AI). This prompted the US Food and Drug Administration (FDA) to issue guidance that recognizes the increasing use of AI and data analytics in drug development. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Cohance, Veranova invest in bioconjugation suites in US; ChemExpress inks ADC deal Earlier this year, Indian drugmaker Suven Pharmaceuticals Limited merged with leading CDMO Cohance Lifesciences Limited. The merged entity — Cohance Lifesciences — has invested US$ 10 million in a current Good Manufacturing Practice (cGMP) bioconjugation suite at its subsidiary NJ Bio in Princeton, New Jersey. NJ Bio is executing a major program for an existing innovator client with multiple antibody-drug conjugate (ADC) candidates. Cohance also announced an INR 230 million (approximately US$ 2.58 million) investment in a cGMP oligonucleotide facility at its Hyderabad (India) site. Veranova’s Devens (Massachusetts) site successfully passed a routine FDA cGMP surveillance inspection with a “No Action Indicated” (NAI) classification. Earlier, the company had initiated a US$ 50 million investment to expand its ADC and bioconjugate capabilities at its Devens site. This includes a 9,000-square-foot facility expansion with a new process development lab, two additional cGMP suites, and state-of-the-art bioconjugation development and manufacturing capabilities. These initiatives strengthen the site’s highly potent API (HPAPI) and ADC development and manufacturing capabilities. Biosynth has expanded its Berlin facility with a new GMP bioconjugation suite. The expansion supports the company’s manufacturing capabilities in conjugate vaccines, conjugate drugs, activated polyethylene glycol (PEGs), and polymer-based drug delivery excipients. ChemExpress, Mabwell Bioscience, and Insilico Medicine have entered into a strategic partnership to jointly develop a large ADC compound library and advance next-generation ADC candidates. The collaboration combines Mabwell’s antibody and ADC technology, Insilico’s AI-powered drug design platform, and ChemExpress’s expertise in linker-payload chemistry. Together, they aim to build a complete, AI-driven ADC development model that accelerates discovery, optimization, and commercialization. This partnership is expected to enhance R&D efficiency and deliver safer, more effective cancer treatments. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Fermion, Axplora, Aenova increase API manufacturing capacities; ICE Pharma expands India facility Finnish CDMO Fermion Oy has launched a renovation project at its Hanko (Finland) production site to modernize its API manufacturing capabilities. This expansion is part of Fermion's broader strategy to increase production, enhance flexibility in the manufacturing of both existing and future pharmaceutical products, and enable potential contract manufacturing opportunities. German CDMO Axplora has announced a €6.5 million (approximately US$ 7.5 million) investment to expand its API manufacturing capacity at its Vizag site in India. This expansion aims to strengthen both production capabilities and supply chain resilience. India-based Aarti Pharmalabs has inaugurated the first phase of its greenfield manufacturing facility in Gujarat (India). This expansion aims to bolster Aarti's CDMO and contract manufacturing organization (CMO) services, targeting a revenue goal of INR 10 billion (approximately US$ 112 million). Snapdragon Chemistry, which was acquired by Cambrex in 2023, has expanded its Massachusetts facility to better support peptide drug development and manufacturing. With this upgrade, the company can now handle peptide projects from early development through full-scale manufacturing. Italy-headquartered ICE Pharma has expanded its Raichem facility in India. The new facility will enhance the production of ursodeoxycholic acid (UDCA), an API it derives from chicken bile. This expansion increases the site’s raw UDCA output by 120 metric tons annually. Spain-headquartered AGC Pharma Chemicals inaugurated a new advanced manufacturing plant in Barcelona, with an investment of €110 million (approximately US$ 128.3 million). The plant spans 7,500 square meters and integrates cutting-edge technologies to support the entire drug development lifecycle — from R&D to commercial manufacturing. This represents a 30 percent increase in the company’s production capacity and introduces a segment dedicated to HPAPIs. Germany-headquartered Aenova has launched a new hot melt extrusion platform at its Regensburg (Germany) site. This new equipment enables the production of advanced drug formulations, while handling all testing and quality checks in-house. The move strengthens Aenova’s capabilities in developing and manufacturing complex medications. US-based Cytovance Biologics has introduced in-house formulation development services, enhancing its role as a comprehensive partner for biologic drug developers. These services utilize quality-by-design principles to ensure speed, safety, and precision in current and future client programs. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Ofichem acquires Avivia BV; Evonik, Samsung Biologics form strategic collaborations Europe-based CDMO Ofichem Group announced the acquisition of Avivia BV, a formulation development company in the Netherlands. This acquisition is part of Ofichem’s strategy to become a fully integrated provider of development solutions across both drug substance and drug product, with a focus on complex formulations. Ofichem has also acquired Meribel Pharma Solutions’ site in Uppsala (Sweden) to strengthen its support for biotech innovators and expand its presence in the Nordic region. Simtra BioPharma Solutions has acquired a 65-acre property near its Bloomington, Indiana (US) facility, adding over 300,000 square feet of potential expansion space. With this site, Simtra now has the flexibility to rapidly expand in the US. German specialty chemicals company Evonik is partnering with German biotech Ethris to develop and commercialize a next-generation lipid nanoparticle (LNP) platform for delivering nucleic acid therapies. Evonik will assist in formulation using Ethris’ SNaP LNP technology. The LNP market alone is projected to grow to US$2.3 billion by 2032. Luxembourg-headquartered Fareva has partnered with Zhaoke Ophthalmology to expand its footprint in China’s pharma market. Zhaoke will act as Fareva’s go-to partner for customers seeking pharmaceutical manufacturing in China. Samsung Biologics has signed a 1.8 trillion won (US$ 1.3 billion) manufacturing agreement with an undisclosed US-based drugmaker. And UK-based eXmoor Pharma has partnered with Anthony Nolan to provide end-to-end services for cell therapy developers. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Our view The global CDMO market, valued at around US$ 255 billion in 2025, is projected to grow to over US$ 465 billion by 2032. Significantly, about 60 percent of new drug approvals in the US and over 65 percent in Europe now involve CDMO support. The developments outlined above underscore the increasing role CDMOs are playing today in bringing about growth and innovation in the pharmaceutical industry.

Impressions: 321

CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord). Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation.

Impressions: 8378

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: 4160

Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397 Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17 13 37 Taiwan 9 6 5 4 24 Switzerland 15 4 4 23 France 16 6 22 Japan 18 1 19 United Kingdom 12 1 2 15 Mexico 9 1 1 11 Ireland 5 5 1 11 Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years.

Impressions: 14487

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: 4517