Technician manufacturing Simplist syringes

Manufacturer prepared syringes

We all play a vital role in the fight against COVID-19.

The people of Fresenius Kabi are ready. Combining our strengths, experience, and passion is how we work, even in normal times.

Many of our products are now being used to treat respiratory conditions and other complications caused by this coronavirus, and we know that in the coming days and weeks we all will be called upon to do much more. That’s why we’re ramping up production of critical injectable medicines across our expanding US manufacturing network.

Today, we stand shoulder to shoulder to care for the lives of those around us and help to ensure that communities across the country emerge from this crisis stronger than ever.

We manufacture high-quality, essential, life-saving medicines.

Simplist ready-to-administer prefilled syringes are manufactured by Fresenius Kabi, which operates 90 state-of-the-art manufacturing plants and R+D centers globally.

We have over 100 years of history supplying healthcare providers with over 500 million units annually of the generic injectable medications they need to provide life-saving care. We have a long history of expertise, and we’re putting that knowledge to use by advancing the state of care.

Manufacturer prepared syringes eliminate the need for compounding.

Compounded drugs can serve an important medical need for patients, but they do not have the same safety, quality, and effectiveness assurances as approved drugs.1 Unnecessary use of compounded drugs unnecessarily exposes patients to potentially serious health risks.1 Drugs compounded by an outsourcing facility can qualify for exemptions from FDA approval requirements and the requirement to label products with adequate directions for use, but not from current good manufacturing practice (cGMP) requirements.2

Simplist ready-to-administer (RTA) prefilled syringes are manufactured under cGMP by Fresenius Kabi in two FDA registered plants, and provide a 24- or 36-month shelf life. Each Simplist product is produced under an approved drug application with the FDA.

Adherence to the cGMP regulations enforced by the FDA, along with the rigor of the FDA drug application review and approval process, assures the identity, strength, quality, and purity of drug products by requiring manufacturers of medications adequately control manufacturing operations.3

  • cGMP + FDA-approved
  • Manufacturer prepared
  • 24- or 36-month shelf life
  • Clear and distinct labeling

Manufacturing Simplist Prefilled Syringes

Simplist syringes manufactured at our Wilson, North Carolina plant are formulated, filled, and packaged using fully-automated state-of-the-art technology.

We have made significant capacity expansion investments in Simplist filling and packaging lines.

Fresenius Kabi acquired the Simplist portfolio and manufacturing site to provide injectable medications in ready-to-administer delivery systems. Continued investment in our portfolio and expansion of our manufacturing line is our commitment to advancing medication safety.

We strive to find answers to the challenges our customers face. We invested in MicroVault® — enhanced packaging of controlled substances — supporting secure dispensing and diversion deterrence. We deliver solutions with technology and resources available to us to maximize positive outcomes for patients.

Delivering Critical Products During Drug Shortages

In 2018-2019, we received multiple awards for our commitment and response to preventing or alleviating drug shortages of medically necessary drugs from the FDA, Vizient, and McKesson.

Simplist syringes are manufactured in two plants

The Wilson, North Carolina plant is a state-of-the-art, fully-automated manufacturing facility with a $100 million investment in the expansion and creation of more than 400 new jobs. Prefilled syringe lines are produced at this location by incorporating integrated isolator technology. The site expansion includes a standard solutions bag filling building in addition to the prefilled syringe lines.

The Graz, Austria facility manufactures syringes and sterile pharmaceuticals specializing in complex process requirements and innovative new technologies. The plant operates in compliance with national, European and US GMP regulations, supplying domestic and international markets through affiliate structures.

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