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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: 1824

BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

Over the last two years, there has been a significant surge in layoffs by pharmaceutical and biotech companies. The trend spilled over to 2024. Data compiled by PharmaCompass indicates that between January and early-September, around 150 companies had implemented layoffs. Bristol Myers Squibb (BMS) tops the list of companies that downsized, with a staggering 2,284 job cuts. Bayer stood second at 1,816 retrenchments, followed by Takeda Pharmaceuticals at 1,155. Johnson & Johnson’s spin-off Kenvue is slashing over 1,000 jobs this year, while Roche subsidiary Genentech is cutting 529 positions, and Novartis is going ahead with its multi-year restructuring, and cutting another 770 jobs. One of the primary drivers of layoffs has been the need for companies to streamline operations and reduce costs. Many firms have faced financial pressures due to reasons such as declining revenues, increased competition, and the high costs associated with drug development. The current wave of layoffs has encompassed geographies – from traditional pharma strongholds like New Jersey, biotech hubs in Massachusetts and California, to Europe (particularly Germany and Switzerland). This is not to suggest that job cuts are a norm. Certain segments have been experiencing substantial growth and job creation. This includes companies like Eli Lilly and Novo Nordisk that have experienced remarkable growth due to the efficacy of their glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that treats type 2 diabetes and obesity. View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) BMS cuts 2,284 jobs to meet cost targets, Bayer hands pink slips to 1,816 employees Several large drugmakers have announced job cuts this year in order to meet their cost cutting goals, or as part of their restructuring exercise. BMS’ revenue had declined from US$ 46.2 billion in 2022 to US$ 45 billion in 2023. The financial pressure has compelled it to cut 2,284 jobs so far in this year, a move that sent shockwaves through the industry. Overall, BMS hopes to save approximately US$ 1.5 billion in costs by 2025 through this “strategic productivity initiative”. In Europe, Swiss-based companies like Novartis and Roche have announced substantial job cuts, while Bayer is reducing its workforce globally. Bayer is laying off 1,816 employees worldwide, including 150 in Basel, Switzerland. A majority of these are management roles as the German drugmaker seeks to target € 500 million (US$ 557 million) in cost savings in 2024 and € 2 billion (US$ 2.23 billion) in 2026. Japanese drugmaker Takeda plans to eliminate 1,155 positions, including 324 jobs in San Diego and 641 in Massachusetts. Takeda is also winding down production and R&D operations in Austria, resulting in 190 job losses. Starting next month, Genentech, a Roche subsidiary, will lay off 93 employees in San Francisco. Earlier this year, Genentech trimmed roughly 3 percent of its workforce across several departments, impacting 436 employees. Roche also laid off around 340 employees in its product development team. Novartis has been undergoing a significant restructuring exercise since 2022, when it announced 8,000 job cuts in its global workforce. This year, it announced an additional 770 job cuts in its product development organization, separate from the previous reductions. Once again, it was workforces in Switzerland (440 job cuts) and US (269 job cuts) that bore the brunt. Tylenol and Band-Aid maker Kenvue, which spun off from J&J last year, announced plans to cut 920 jobs, representing about 4 percent of its global workforce. Additionally, the company will lay off 51 employees in New Jersey and 84 in California. These layoffs are part of Kenvue’s efforts to adjust its cost structure and become more competitive. View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) Perrigo, Emergent Bio, Catalent, BioMarin trim workforces amid strategic shifts Several mid-size companies too are under tremendous cost pressures, with some of them feeling the need to reinvent themselves for the future. In February this year, Perrigo had embarked on ‘Project Energize’, a three-year initiative aimed at boosting organizational agility and achieving long-term success. As part of this project, Perrigo is cutting costs and laying off 6 percent of its staff, which translates into nearly 550 employees. CDMO-turned-biopharma Emergent BioSolutions plans to reduce its workforce by about 300 employees. The Maryland-based multinational is closing its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility in the state. Rare disease biotech BioMarin laid off 395 employees globally, about 12 percent of its workforce, as part of “organizational redesign efforts” to prioritize its new strategy with its hemophilia A gene therapy Roctavian and to preserve cash. Drug-delivery specialist Catalent has also been significantly impacted by restructuring efforts ever since it announced 1,100 layoffs in December. It had then attributed its fall in revenue to declining Covid-related sales, but had also noted that future GLP-1 manufacturing revenues could help stabilize its finances. True enough — it subsequently announced that it is in the process of being acquired by Novo Nordisk’s parent company for US$ 16.5 billion. However, Catalent reported reducing its headcount by an additional 300 in the fourth quarter of 2023. View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) Pfizer job cuts continue to trickle in; Lykos, Lyra downsize after pipeline setbacks Clinical trial failures and financial constraints have also played a significant role in this year’s wave of layoffs. At Pfizer, job cuts continued to trickle in, with some estimates putting the number at 1,500 employees in 2024. These include 285 at its vaccine R&D site in New York, and 52 in San Francisco. The Comirnaty maker also pulled the plug on a long-anticipated, near-complete Seagen drug manufacturing plant in Everett, Washington. About 120 employees at the site were let go. It has been a tumultuous time for Lykos Therapeutics, following the US Food and Drug Administration’s rejection of its MDMA-assisted therapy for post-traumatic stress disorder. Lykos announced laying off 75 percent of its staff (i.e. 75 employees). Its founder, who had spent 38 years working on the therapy, left the company and so did its CEO. However, Lykos has not given up and has roped in a Janssen veteran as senior medical advisor to get the therapy past the finish line. Similarly, Lyra Therapeutics is laying off 75 percent of its workforce (i.e. 87 employees) following disappointing late-stage results for its implant to treat chronic rhino-sinusitis. The retrenchments include its chief technology officer. View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) Our view Technology, regulatory and pricing pressures are shaping strategies of pharmaceutical companies. The drive to do more with less could accelerate the adoption of artificial intelligence, machine learning, and automation in drug discovery and development processes. The employment landscape is certainly evolving. We foresee significant changes in the skills required for pharmaceutical and biotech careers, with a growing emphasis on data science and computational biology.

Impressions: 2563

Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards. Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio. Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients. The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.

Impressions: 1966

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: 3233

NEWS #PharmaBuzz

Evonik with ST Pharm to increase offerings for RNA & nucleic acid delivery

09 Jan 2025

// PRESS RELEASE

Silexion Partners with Evonik on siRNA Formulation Development

17 Dec 2024

// GLOBENEWSWIRE

European Food Safety Authority confirms safety of silica

26 Oct 2024

// PRESS RELEASE

Evonik plots 260 layoffs as it winds down some production ops

14 Oct 2024

// FIERCE PHARMA

Evonik to Restructure Keto and Pharma Amino Acid Business

11 Oct 2024

// PRESS RELEASE

Evonik wins CPHI Pharma Award for its plant-based PhytoSquene®

09 Oct 2024

// PRESS RELEASE

ALL APIs

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USDMF

01

Azelastine Hydrochloride

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15440

Submission : 2001-05-15

Status : Active

Type : II

02

Chlorhexidine Base

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5926

Submission : 1985-07-02

Status : Active

Type : II

03

Chlorhexidine Digluconate

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8379

Submission : 1990-01-19

Status : Active

Type : II

04

Glycine

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-31

Pay. Date : 2016-12-27

DMF Number : 30393

Submission : 2016-03-02

Status : Active

Type : II

05

L - Serine

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37552

Submission : 2022-10-13

Status : Active

Type : II

06

L-alanine

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19769

Submission : 2006-08-28

Status : Active

Type : II

07

L-alanyl-l-glutamine

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9486

Submission : 1992-01-03

Status : Active

Type : II

08

L-aspartic Acid

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19766

Submission : 2006-08-28

Status : Active

Type : II

09

L-lysine Hydrate

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 3872

Submission : 1980-07-11

Status : Active

Type : II

10

L-methionine

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18726

Submission : 2005-08-31

Status : Active

Type : II

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CEP/COS

01

Alanine

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : R1-CEP 2004-086 - Rev 07

Status : Valid

Issue Date : 2023-08-24

Type : Chemical

Substance Number : 752

02

Asparagine monohydrate

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : R1-CEP 2010-172 - Rev 01

Status : Withdrawn by Holder

Issue Date : 2019-09-19

Type : Chemical

Substance Number : 2086

03

Aspartic Acid

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : CEP 2004-216 - Rev 04

Status : Valid

Issue Date : 2023-11-14

Type : Chemical

Substance Number : 797

04

Azelastine hydrochloride

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : CEP 2009-333 - Rev 05

Status : Valid

Issue Date : 2024-04-24

Type : Chemical

Substance Number : 1633

05

Chlorhexidine digluconate solution

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : R1-CEP 2001-343 - Rev 05

Status : Valid

Issue Date : 2020-08-31

Type : Chemical

Substance Number : 658

06

Dimercaprol

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : R1-CEP 2007-330 - Rev 02

Status : Valid

Issue Date : 2020-11-09

Type : Chemical

Substance Number : 389

07

DL-Methionine

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : R1-CEP 2006-139 - Rev 06

Status : Valid

Issue Date : 2023-08-24

Type : Chemical

Substance Number : 624

08

Glutamic Acid

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : CEP 2009-311 - Rev 01

Status : Valid

Issue Date : 2024-01-29

Type : Chemical

Substance Number : 750

09

Glycine

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : CEP 2008-099 - Rev 05

Status : Valid

Issue Date : 2023-10-03

Type : Chemical

Substance Number : 614

10

Hydrogen peroxide solution (30 per cent)

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Certificate Numbers : CEP 2018-079 - Rev 04

Status : Valid

Issue Date : 2024-03-28

Type : Chemical

Substance Number : 396

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JDMF

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KDMF

01

Azelastine hydrochloride

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Registrant Name : Bukwang Pharmaceutical Co., Ltd.

Registration Date : 2008-08-29

Registration Number : 20080829-44-C-224-06

Manufacturer Name : Evonik Operations GmbH

Manufacturer Address : Rodenbacher Chaussee 4 63457 Hanau, Germany

02

Duloxetine hydrochloride

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Registrant Name : Korea Lily (U.S.)

Registration Date : 2007-01-25

Registration Number : Su51-3-ND

Manufacturer Name : Evonik Corporation

Manufacturer Address : Tippecanoe Laboratories1650 Lilly Road Lafayette, IN 47909

Product
Web Link

03

Emtricitabine

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Registrant Name : Gilead Sciences Korea Ltd.

Registration Date : 2014-12-04

Registration Number : No. 4945-20-ND

Manufacturer Name : Evonik Operations GmbH

Manufacturer Address : Gutenbergstrasse 2, 69221 Dossenheim, Germany

Product
Web Link

04

Gemcitabine hydrochloride

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Registrant Name : Boryeong Co., Ltd.

Registration Date : 2007-12-28

Registration Number : 20071228-86-D-24-04

Manufacturer Name : Evonik Corporation

Manufacturer Address : Tippecanoe Laboratories Lafayette, Indiana, USA (1650 Lilly Road)

Product
Web Link

05

Lisinopril dihydrate

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Registrant Name : Hyundai Pharmaceutical Co., Ltd.

Registration Date : 2021-05-14

Registration Number : 20210514-209-J-989

Manufacturer Name : Evonik Operations GmbH@Evonik ...

Manufacturer Address : Rodenbacher Chaussee 4 63457 Hanau Germany@33 rue de Verdun 80400 Ham, FRANCE

06

Tadalafil

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Registrant Name : Korea Lily (U.S.)

Registration Date : 2021-10-14

Registration Number : 20211014-203-I-626-17

Manufacturer Name : Evonik Corporation@Powdersize ...

Manufacturer Address : Tippecanoe Laboratories, 1650 Lilly Road Lafayette, Indiana 47909, USA_x000D_ _x000D_...

Product
Web Link

07

Verteporfin

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

Registrant Name : DKS Korea Co., Ltd.

Registration Date : 2003-04-18

Registration Number : 163-1-ND

Manufacturer Name : Evonik Degussa Canada Inc.

Manufacturer Address : 8045 Argyll Road, Edmonton, Alberta, T6C 4N9, Canada.

Product
Web Link

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NDC API

01

ALANINE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 16947-8204

Start Marketing Date : 2006-08-28

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

02

ALANYL GLUTAMINE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 51593-5005

Start Marketing Date : 1992-01-03

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Product
Web Link

03

ALECTINIB HYDROCHLORIDE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 62128-0384

Start Marketing Date : 2015-12-11

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Product
Web Link

04

AZELASTINE HYDROCHLORIDE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 49274-1101

Start Marketing Date : 2001-05-15

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

05

BALOXAVIR MARBOXIL

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 62128-0394

Start Marketing Date : 2021-12-02

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Product
Web Link

06

DULOXETINE HYDROCHLORIDE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 62128-0386

Start Marketing Date : 2004-08-03

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Product
Web Link

07

EMTRICITABINE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 52696-0008

Start Marketing Date : 2007-10-23

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Product
Web Link

08

ENZALUTAMIDE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 62128-0388

Start Marketing Date : 2015-09-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Product
Web Link

09

GEMCITABINE HYDROCHLORIDE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 62128-0383

Start Marketing Date : 1996-05-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : EXPORT ONLY

Product
Web Link

10

GLYCINE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

NDC Package Code : 16947-8205

Start Marketing Date : 2016-03-02

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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VMF

01

CLORSULON PURE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

VMF Number : 5716

Submission : 2001-05-07

Status : Inactive

Type : II

Product
Web Link

02

FLUPIRTINE MALEATE

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

VMF Number : 5769

Submission : 2003-03-12

Status : Inactive

Type : II

Product
Web Link

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LISTED APIs

01

Alpha Hydroxymethionine Calcium

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

About the Company : Evonik is one of the world leaders in specialty chemicals.
The company is active in >100 countries around the world & generated sales of €15.3 billion & an operating profit (adjusted EBIT...

02

Alpha-Ketovaline Calcium

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

03

Dimercaprol

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

04

Lorazepam

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Evonik

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Drugs in Development

01 Evonik

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Lead Product(s) : Cellulose

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : JeNaCell

Deal Size : Not Applicable

Deal Type : Not Applicable

Evonik Company JenaCell Launches Wound Dressing Epicite® Balance for Chronic Wounds

Details : epicite® balance is made of biosynthetic cellulose, a hydropolymer for innovative medical device applications. The dressing enables superior wound cleansing effects and reactivates the healing of slow-healing wounds.

Brand Name : Epicite® Balance

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 14, 2023

02 Evonik

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Lead Product(s) : Cellulose

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : JeNaCell

Deal Size : Not Applicable

Deal Type : Not Applicable

Evonik Company JeNaCell Launches Wound Dressing Epicite® Balance for Chronic Wounds

Brand Name : Epicite® Balance

Molecule Type : Large molecule

Upfront Cash : Not Applicable

June 13, 2023

03 Evonik

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Lead Product(s) : Bupivacaine

Therapeutic Area : Neurology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Allay Therapeutics

Deal Size : Not Applicable

Deal Type : Not Applicable

No Opioids After Surgery: Evonik Invests in Allay Therapeutics and Supplies Key Technology for Pai...

Details : ATX-101 is a small product placed directly into the TKA surgical site in a simple, ‘place & go’ manner designed to add minimal extra complexity and time to the procedure.

Brand Name : ATX-101

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 13, 2022

04 Evonik

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Lead Product(s) : Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Phathom Pharmaceuticals

Deal Size : Undisclosed

Deal Type : Agreement

Evonik and Phathom Pharmaceuticals Partner to Produce Novel Acid-Blocker Vonoprazan

Details : Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.

Brand Name : Voquezna Triple Pack

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 24, 2022

05 Evonik

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Lead Product(s) : mRNA-based Therapy

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Undisclosed

Partner/Sponsor/Collaborator : BARDA

Deal Size : $220.0 million

Deal Type : Funding

Evonik Invests US$220 Million in Partnership with The U.S. Government to Build New Lipid Productio...

Details : Lipids, molecules that make up the building blocks of living cells, are critical to producing mRNA-based drugs. The mRNA is enclosed in a lipid nanoparticle (LNP) composed of specific lipids. The LNP protects the mRNA and delivers it safely into the cell...

Brand Name : Undisclosed

Molecule Type : Large molecule

Upfront Cash : Undisclosed

June 02, 2022

06 Evonik

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Lead Product(s) : Simufilam

Therapeutic Area : Neurology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Cassava Sciences

Deal Size : Undisclosed

Deal Type : Agreement

Evonik and Cassava Sciences Join Forces to Fight Alzheimer’s Disease

Details : Evonik to supply commercial quantities of simufilam, a drug candidate for the treatment of Alzheimer’s disease. Simufilam is a novel drug, discovered at Cassava Sciences, that targets both neuroinflammation and neurodegeneration.

Brand Name : PTI-125

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 09, 2021

07 Evonik

Germany

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Lead Product(s) : Tozinameran

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : BioNTech

Deal Size : Undisclosed

Deal Type : Partnership

Evonik Strengthens Strategic Partnership with Biontech on Covid-19 Vaccine

Details : Lipids are fundamental to produce highly effective mRNA-based vaccines. Only with an increase in lipid supply can the volume of vaccine be further increased. This move marks an expansion of the partnership between Evonik and the Comirnaty, vaccine manufa...

Brand Name : Comirnaty

Molecule Type : Vaccine

Upfront Cash : Undisclosed

February 11, 2021