Evonik

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43 CORPORATE CONTENT #SupplierSpotlight, 3 DATA COMPILATION #PharmaFlow, 242 NEWS #PharmaBuzz

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27 All Excipients, 27 USDMF, 1 NDC API, 2 VMF, 22 Listed Products

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L-Alanine, Amino Methacrylate Copolymer, PLASACRYL T20, L Lysine HCl Excipient, Glycine Excipient, L-Aspartic Acid, Ammonia Methacrylate Copolymer Type A, L-Valine Excipient, L Serine Excipient, L-Proline, DL-Glutamic Acid, Ammonio Methacrylate Copolymer Type B, L-Lysine Acetate, L Threonine Excipient, Methacrylic Acid Copolymer Type B, METHACRYLIC ACID COPOLYMER TYPE A , L-Phenylalanine, L Tryptophan Excipient, Methacrylic Acid - Ethyl Acrylate Copolymer, PLASACRYL HTP20, L-Leucine, DL-Methionine Excipient

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CORPORATE CONTENT #SupplierSpotlight

Product List 2024

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GMP Certificate 2024

Rexiva®

Lipid-based Delivery of Nucleic Acids

PhytoSquene®

Nutraceutical Solutions

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Evonik Strengthens its Animal Nutrition Business

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New U.S Facility for Pharmaceutical Lipids

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Production Capacity for DL-Methionine in Singapore

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Evonik invests $220M with US Govt. for lipid production facility

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Specialty Additives Division Spotlight

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cQrex™ Cell Culture Solutions

Complex Parenterals

Exclusive Synthesis

Oral Drug Delivery Solutions

Resomer®

Nutrition & Care Divison Spotlight

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Smart Materials Division Spotlight

Eudragit®

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Evonik Birmingham Laboratories

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High-quality Generic APIs, Intermediates & Amino Acids

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Your Enabling Partner for Oral Drug Delivery Solutions

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Discover Our New Oral Drug Delivery Lab in Istanbul

CDMO for Advanced Drug Delivery

EUDRATEC® SoluFlow

Drawing Drug Delivery: Liposomes

Coatino®

Evonik Delivers First Lipids from German Facility to BioNTech

Hydrogen Peroxide

Polyamide 12

SEPURAN® Green

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DATA COMPILATION #PharmaFlow

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: 2401

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: 1828

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: 3097

NEWS #PharmaBuzz

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

Evonik Launches Global Network to Optimize Cell Culture Media

02 Oct 2024

// PRESS RELEASE

Evonik Launches EUDRACAP for the Targeted Delivery of Oral Drugs

25 Sep 2024

// PRESS RELEASE

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Evonik is a supplier offers 38 products (APIs, Excipients or Intermediates).

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