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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Minakem to the Review Authority in Korea.

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    Minafin Group appoints Olivier Ubrich as CEO of Health Chemistry Division

    05 Sep 2024

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    The EDQM has validated updated CEP of Vinorelbine of Minakem, sole Mfg in Europe

    25 Jun 2024

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    Minakem Canada is manufacturing steroid APIs in a brand-new production unit

    17 May 2024

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    Minakem is a fully integrated development partner and commercial manufacturer for pharma companies. With around 70 years of experience, Minakem is a technology-driven company with expertise in complex multi-step synthesis, pressure chemistry, chiral synthesis, halogenation chemistry, steroid chemistry and prazole chemistry. It offers custom development & manufacturing, API manufacturing and the production of key intermediates. Minakem has 3 USFDA-approved development and manufacturing sites in France and Belgium. Minakem is an affiliate of the Minafin Group and has access to all technologies, resources, and capabilities.

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    "Minafin appoints Sébastien Poncet, Managing Director of Minakem Generics & New Therapies"

    "Minafin appoints Sébastien Poncet, Managing Director of Minakem Generics & New Therapies"

    Sébastien Poncet is charged with enhancing the portfolio of proprietary processes and seizing opportunities in new therapies. Louvain-la-Neuve, January 27, 2022 – The Health Chemistry division of the Minafin Group today welcomes Sébastien Poncet as managing director of the Minakem Generics and New Therapies business unit. He is also an executive member of the division. Sébastien is a graduate of the Montpellier School of Chemistry Engineering (ENSCM) and holds a master's degree in business: B2B strategy and marketing from EM Lyon and participated in several international management programs from IMD Lausanne and from INSEAD. Over the past 20 years, he has held numerous sales positions at Solvay, Clariant (now Curia), Johnson Matthey, and Minafin. Sébastien is returning to the Minafin Group following an eight-year tenure at Fareva, where for the last two years he was a member of the executive committee. Frédéric Gauchet, chairman of the Minafin Group, said: "Sébastien’s appointment reflects our desire to enhance our portfolio of proprietary processes for manufacturing generic active ingredients in support of the efforts authorities are taking to secure a European drug supply. Minafin has the advanced know-how in fine chemistry required to enable the development of innovative therapies. But in order to remain at the cutting-edge of ‘new technologies,’ we may consider potential acquisitions in high value-added chemistry or biotechnology." Sébastien will focus on developing the business of active pharmaceutical ingredients that are within the public domain and seizing commercial opportunities generated by emerging therapies such as Messenger RNAs. “I am very pleased to start working again with the world-class teams at Minakem. They are globally recognized for their capacity to design innovative chemical routes, to scale them up successfully and their proven track record agility in the field of active ingredients. And I look forward to collaborating with them on the generic API product portfolio that I see has significant growth potential,” said Sébastien “As for new therapies, the sanitary crisis we are going through has demonstrated their importance in the therapeutic arsenal against COVID-19, for example, messenger RNA vaccines. These new technologies developed with high value-added chemistry are where Minakem’s Research & Development know-how can really make a difference in the years to come.” About the Minafin Group Health Chemistry Division The Health Chemistry division develops and manufactures active ingredients for the pharmaceutical industry through its two business units: Minakem CDMO and Minakem Generics & New Therapies. Minakem is the leader in Europe. It offers a wide range of cutting-edge technologies and pharmaceutical services to ensure that its customers have a seamless supply of high-quality products. The company provides its expertise for the development of exclusive manufacturing processes and to produce active pharmaceutical ingredients following cGMP conditions. Patients' needs being at the heart of its activities, the Healthcare Chemistry division ensures that the drugs it manufactures meet the strictest health and environmental safety standards. Minakem CDMO focuses on proprietary custom synthesis while Minakem Generics & New Therapies develops proprietary manufacturing processes for generic active ingredients and innovative therapies. The three production sites of the Healthcare Chemistry division, approved by the FDA, are located in Louvain-la-Neuve (BE), Dunkirk (FR) and Beuvry-la-Forêt (FR). Created in 2004, Minafin's Health Chemistry division employs 550 people. www.minakem.com About the Minafin Group The Minafin Group is a leading process developer and manufacturer of fine chemicals with three main areas of expertise: health chemistry, green chemistry, and challenging chemistry. Minafin operates six industrial manufacturing sites across Europe and North America. They provide customers in pharmaceuticals, life-science ingredients and added-value chemicals for high-tech application, with a range of proprietary processes, custom manufacturing, R&D, analytical and regulatory services, as well as formulations. Minafin invests significantly in R&D to create value for customers by specializing in innovations and eco-friendly solutions that bring a competitive edge and sustainability. Its strong industrial capabilities are consolidated through nine business units: Minakem CDMO, Minakem Generics, Blendamix, Pennakem, Minasolve, Minagro, EcoXtract, Minascent and Pressure Chemicals, which generated over €243M (approx. $280M) in revenue in 2020. Founded in 2004 as a privately held industrial company, Minafin is headquartered in Belgium and employs 900+ staff.  www.minafin.com Press contact: Sylvie Boone –Press Relations Minafin Group –Sylvie.boone@minafin.com –32/497.540.945  

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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    Corporate Presentation

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    GMP Certificate 2023

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    Building Blocks & GMP Excipients 2021

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    CDMO for Custom APIs & HPAPIs

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    Analytical Services

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    A Word With Minakem Teknoscienze

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    Challenging Chemistry in Pharmaceutical Manufacturing

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

    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.   
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