Fresenius Kabi
U.S. subsidiary of Fresenius Kabi, focusing on IV drugs, clinical nutrition, and medical technology.
Last updated October 22, 2026
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Overview
Fresenius Kabi is the healthcare products and therapies business of Germany’s Fresenius Group. It develops, manufactures and supplies medicines, medical devices and clinical nutrition products used principally in hospitals, clinics and other professional-care settings. Its main areas include infusion therapy, intravenous fluids, parenteral nutrition, infusion devices and software, transfusion technology, generic injectable medicines, oncology products, biosimilars and biopharmaceutical manufacturing services. The company’s activities are directed toward patients who are critically ill, chronically ill or dependent on specialized medical treatment. Rather than operating primarily as a consumer-facing pharmaceutical brand, Fresenius Kabi functions as a business-to-business healthcare supplier. Its customers include hospitals, health systems, physicians, pharmacists, blood banks and other institutional providers. The company’s portfolio combines products administered directly to patients with equipment and technology intended to make the administration of medicines, fluids and nutrition safer and more efficient. Fresenius Kabi expanded substantially through acquisitions. The purchase of APP Pharmaceuticals in 2008 established a major North American position in intravenously administered generic drugs, while the acquisition of Dabur Pharma broadened its oncology activities. Fenwal, acquired in 2012, added blood-component collection, processing and apheresis technology. In 2016 the company acquired BD’s U.S. pharmaceutical prefilled-syringe business, strengthening its ready-to-administer offering. In 2017 it entered biosimilars through the acquisition of Merck KGaA’s development pipeline and related Swiss personnel. During the 2020s, Fresenius Kabi pursued a strategy of broadening its biopharmaceutical and medical-technology capabilities. The acquisition of Ivenix added a smart infusion system and associated software, while the majority investment in mAbxience expanded biologics development, manufacturing capacity and contract development and manufacturing capabilities. These moves complemented the company’s established infusion, injectable-drug and nutrition businesses and were presented as part of its Vision 2026 transformation framework. Fresenius Kabi sells products in many countries through a combination of local subsidiaries, regulatory approvals, manufacturing sites and hospital-focused commercial organizations. Its brand positioning emphasizes dependable supply, clinical utility, quality and innovation. Because product names, approvals and availability differ by jurisdiction, the company’s marketed portfolio is not identical in every country. The business remains an active subsidiary of Fresenius SE & Co. KGaA.
History
Fresenius Kabi developed as the medicines, infusion and clinical-nutrition arm of the wider Fresenius healthcare group. Its business model is based on supplying specialized products used in professional care, particularly in hospitals and other institutions treating patients with acute or chronic conditions. The company’s areas of expertise came together around infusion therapy, intravenous medicines, clinical nutrition, transfusion and medical technology. A major phase of international expansion occurred through acquisitions. In 2008, Fresenius Kabi acquired Dabur Pharma, adding oncology products, and APP Pharmaceuticals in the United States, giving the company a stronger position in North American intravenous generic drugs. This helped establish Fresenius Kabi as a substantial supplier of injectable medicines beyond its European base. The company’s portfolio subsequently continued to combine pharmaceutical products with devices and systems used to administer them. In 2012, Fresenius Kabi acquired Fenwal, a transfusion-technology company. The transaction expanded the business into blood-component collection and processing, as well as therapeutic apheresis. This made transfusion technology an important complement to infusion and injectable-drug activities. By 2014, the company reported a presence in more than 160 countries, more than 32,000 employees and over 100 product groups, illustrating the scale of its international operating network. The company broadened its ready-to-administer pharmaceutical portfolio in 2016 through the acquisition of the U.S. BD Rx business from Becton Dickinson. The deal added prefilled-syringe products and supported Fresenius Kabi’s focus on products designed for efficient and safe use in clinical settings. In 2017, Fresenius Kabi entered the biosimilars field by acquiring Merck KGaA’s biosimilars business. The acquired assets included a development pipeline concentrated on oncology and autoimmune diseases and a team located in Aubonne and Vevey, Switzerland. Fresenius Kabi completed the transaction later that year. The move gave the company a platform in a growing segment of biological medicines and complemented its established injectable-pharmaceutical business. The first Fresenius Kabi biosimilar in Europe was launched in 2019. The company’s more recent development has emphasized broader biopharmaceutical capabilities and medical technology. Fresenius Kabi introduced Vision 2026 in 2021 as a strategic framework for transforming the business. In 2022 it acquired Ivenix, a U.S. medical-technology company whose smart infusion system combined infusion hardware with software. The transaction was intended to add next-generation pump technology to Fresenius Kabi’s existing intravenous-fluid and infusion portfolio. Also in 2022, Fresenius Kabi completed the acquisition of a majority stake in mAbxience Holding S.L. The investment expanded its biologics product and development portfolio and added manufacturing facilities for biologic drug substance. It also created a route into the biologics contract development and manufacturing organization market. Together, the Ivenix and mAbxience transactions represented an effort to move beyond the company’s traditional product base while retaining infusion therapy, clinical nutrition and injectable medicines as core activities. Today, Fresenius Kabi operates internationally as a Fresenius Group subsidiary. Its business spans medicines, nutrition, infusion and transfusion technologies, devices, software and biopharmaceutical services. Product availability and regulatory status vary by market, but the company’s common identity is as a healthcare supplier serving professional caregivers and patients requiring hospital-based or specialized treatment.
- 2022
Ivenix and mAbxience transactions
[2]Fresenius Kabi acquired Ivenix and completed a majority investment in mAbxience, broadening its medical-technology and biopharmaceutical capabilities.
- 2021
Vision 2026 introduced
[2]The company introduced a transformation and growth framework known as Vision 2026.
- 2019
First European biosimilar launch
[2]Fresenius Kabi launched its first biosimilar in Europe.
- 2017
Entry into biosimilars
[3]Fresenius Kabi acquired Merck KGaA’s biosimilars development pipeline and related Swiss team.
- 2016
BD Rx business acquisition
[2]The company acquired BD’s U.S. pharmaceutical prefilled-syringe business and expanded its ready-to-administer portfolio.
- 2012
Fenwal acquisition
[2]Fresenius Kabi acquired Fenwal, adding blood-component collection, processing and therapeutic apheresis technologies.
- 2008
Expansion into North American injectables and oncology
[2]Acquisitions of APP Pharmaceuticals and Dabur Pharma strengthened Fresenius Kabi’s North American intravenous-generics business and expanded its oncology portfolio.
Products and positioning
A hospital-focused healthcare technology and medicines company positioned around reliable supply, clinical quality, integrated treatment solutions and access to specialized therapies.
Parenteral nutrition
Clinimix
A parenteral-nutrition product line used to provide patients with macronutrients through intravenous administration when oral or enteral nutrition is not sufficient or possible. Formulations and market availability vary by country.
Parenteral nutrition
Kabiven
A multi-chamber parenteral-nutrition product family combining major nutritional components for intravenous use. It is intended for clinical settings in which patients require structured nutrition support.
Lipid injectable emulsion
SMOFlipid
An injectable lipid-emulsion product used as part of parenteral nutrition. It is formulated for hospital nutrition-support practice and is marketed in multiple jurisdictions subject to local approvals.
Lipid injectable emulsion
Omegaven
An intravenous fish-oil-based lipid emulsion used in specialized parenteral-nutrition care. Its approved indications and labeling depend on the jurisdiction in which it is supplied.
Parenteral nutrition
Nutriflex
A range of intravenous nutrition products designed for patients requiring parenteral nutritional support. The line includes different formulations intended to address varying clinical nutrition requirements.
Smart infusion technology · 2019
Ivenix infusion system
An infusion platform combining pump hardware, administration technology and software. Fresenius Kabi acquired Ivenix to complement its intravenous-fluid and infusion-therapy portfolio, particularly in the North American market.
Controversies
2026
Fresenius Kabi recalls Tyenne arthritis injection lot over glass particles
Fresenius Kabi initiated a nationwide recall of one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL vials after an internal investigation found glass particles in the product, which the company warned could cause local irritation, vein inflammation, blood vessel blockage and clotting, pulmonary embolism, permanent organ damage or death. The recall, announced by the FDA on Aug. 11, covers lot 16UI07 (NDC 65219-594-20), shipped between March 3 and 25, 2026, with an August 2028 expiration date, and sold to wholesalers, distributors and customers across the United States.
2020
QuVa Pharma recalls R.E.C.K. product lots
QuVa Pharma announced a voluntary recall of all lots of its R.E.C.K. 50 ml product prepared using ketorolac that had been recalled by Fresenius Kabi. QuVa stated that it contacted affected hospital pharmacy customers and asked them to quarantine remaining product, report unused quantities, and return finished goods for destruction. The source reports that the ketorolac recall was due to particulate matter found in reserve sample vials.
Marketing campaigns
- 2021Parenteral Nutrition Portfolio Repositioning
United States
Fresenius Kabi’s U.S. parenteral-nutrition marketing team developed a portfolio-level campaign to connect Omegaven, SMOFlipid and Kabiven more clearly with the Fresenius Kabi brand. The effort addressed low awareness that the products belonged to one broader portfolio and sought to reinforce the company’s position in the parenteral-nutrition market.
Outcome. The campaign was recognized by PM360’s 2021 ELITE program. The available material does not provide independently verified sales or market-share results.
Brand decisions
2022
Acquire IvenixM&ABackground
Fresenius Kabi wanted to strengthen its infusion-technology offering with a smart system combining pump technology and software.
Action taken
The company agreed to acquire U.S.-based Ivenix for $240 million upfront, plus potential milestone payments tied to commercial and operating targets.
Aftermath
The transaction added a next-generation infusion platform to Fresenius Kabi’s existing fluids and infusion business.
Upfront acquisition consideration. $240 million, plus potential milestone payments (2022 announced transaction)
2022
Acquire a majority stake in mAbxienceM&ABackground
Fresenius Kabi sought to broaden its biopharmaceutical portfolio, add biologics manufacturing capacity and enter the biologics CDMO market.
Action taken
The company completed the acquisition of a majority stake in mAbxience Holding S.L., with consideration consisting of approximately €495 million upfront plus milestone payments.
Aftermath
The transaction expanded Fresenius Kabi’s biologics manufacturing network and supported its biosimilars and contract-manufacturing ambitions.
Upfront acquisition consideration. Approximately €495 million, plus milestone payments (2022 transaction)
2021
Introduce Vision 2026StrategyBackground
Fresenius Kabi aimed to transform its business and prioritize growth areas beyond its established infusion, nutrition and injectable-medicines base.
Action taken
The company introduced Vision 2026 as a strategic framework covering areas including biopharmaceuticals and medical technology.
Aftermath
The strategy was followed by the Ivenix and mAbxience transactions in 2022.
2017
Acquire Merck KGaA’s biosimilars businessM&ABackground
Fresenius Kabi sought entry into the growing biosimilars sector and a broader platform in oncology and autoimmune diseases.
Action taken
The company acquired Merck KGaA’s biosimilars development pipeline and associated employees in Switzerland. The completed transaction had a total potential consideration of €656 million, including milestone-linked payments.
Aftermath
The acquisition was consolidated in September 2017, and Fresenius Kabi later identified 2019 as the year of its first European biosimilar launch.
Purchase consideration. €656 million maximum, including €156 million paid at closing and up to €500 million in milestone payments (2017 transaction)
Recent events
Reported
Fresenius Kabi recalls Tyenne arthritis injection lot over glass particles[9]
Fresenius Kabi initiated a nationwide recall of one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL vials after an internal investigation found glass particles in the product, which the company warned could cause local irritation, vein inflammation, blood vessel blockage and clotting, pulmonary embolism, permanent organ damage or death. The recall, announced by the FDA on Aug. 11, covers lot 16UI07 (NDC 65219-594-20), shipped between March 3 and 25, 2026, with an August 2028 expiration date, and sold to wholesalers, distributors and customers across the United States.
Reported
Cellular Origins and Fresenius Kabi sign development agreement[11]
Cellular Origins and Fresenius Kabi signed a development agreement to work on digitally and physically integrating Fresenius Kabi’s cell therapy technologies into Cellular Origins’ Constellation manufacturing platform. Initial integration work focuses on the Cue Cell Processing System.
Reported
QuVa Pharma recalls R.E.C.K. product lots[10]
QuVa Pharma announced a voluntary recall of all lots of its R.E.C.K. 50 ml product prepared using ketorolac recalled by Fresenius Kabi. QuVa said it contacted affected hospital pharmacy customers and asked them to quarantine remaining product, report unused quantities, and return finished goods for destruction. The source says the ketorolac recall was due to particulate matter found in reserve sample vials.
Sources11 sources
- 1Fresenius Kabi Global Websitefresenius-kabi.com
- 2A Heritage of Caring: Company Milestonesfresenius-kabi.com
- 3Fresenius Kabi completes acquisition of Merck KGaA’s biosimilars businessfresenius.com
- 4Fresenius Kabi buys a majority stake in mAbxience and acquires Ivenixfresenius.com
- 5Fresenius Kabi completes majority stake acquisition of mAbxiencemabxience.com
- 6The Fresenius Kabi Parenteral Nutrition Teampm360online.com
- 7Fresenius Kabi acquires Merck KGaA’s biosimilars businessbiopharminternational.com
- 8Upfront acquisition considerationdrugdeliverybusiness.com
- 9Fresenius Kabi recalls Tyenne arthritis injection lot over glass particlestheepochtimes.com
- 10QuVa Pharma recalls R.E.C.K. product lotsprnewswire.com
- 11Cellular Origins与Fresenius Kabi签署开发协议finanznachrichten.de
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