Manufacturer prepared syringes

Advancing medication safety

Simplist syringes help make it easier to minimize risk while enhancing efficiency.

We’re committed to advancing medication safety across the continuum of care by providing the medications you need in a manufacturer prepared prefilled syringe that can help reduce the risk of preparation and administration errors.

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
Compounding Info
Technicians operating state-of-the-art manufacturing facility

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.
Technicians operating state-of-the-art manufacturing facility

Delivering Critical Products During Drug Shortages

Fresenius Kabi has 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

Technicians operating state-of-the-art manufacturing facility

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.

Technicians operating state-of-the-art manufacturing facility

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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About Fresenius Kabi
References:
1.

U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. Accessed December 15, 2021.

2.

U.S. Food and Drug Administration. Information for Outsourcing Facilities. Accessed January 5, 2022.

3.

U.S. Food and Drug Administration. Facts About the Current Good Manufacturing Practices (CGMPs). Accessed October 25, 2021.

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To place an order, contact your Sales Representative or call Customer Service at 1.888.386.1300.
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