Assure Infusions

What Assure Infusions does

Assure Infusions is a privately-held, US-based 503B outsourcing facility and contract development and manufacturing organization (CDMO) headquartered at 275 Century Blvd, Bartow, Florida. The company manufactures sterile intravenous (IV) fluids — specifically Sodium Chloride, Dextrose, Lactated Ringers, and Sterile Water for Injection — in 250 mL, 500 mL, and 1000 mL flexible IV bag configurations for sale to hospitals and healthcare providers nationwide. It was founded in direct response to the chronic sterile IV fluid shortage that has affected US healthcare systems for over a decade, with its operational design informed by FDA warnings issued to incumbent manufacturers and compounders.

The firm's core technology is a fully automated, human touch-free fill-finish manufacturing line integrated with terminal sterilization, housed in a state-of-the-art facility that the company explicitly contrasts with industry-standard plants aged 30–40 years. This architecture is intended to enable agile batch production and rapid pivot to address specific shortage SKUs, while maintaining sterility standards even for smaller runs. All operations run under full cGMP compliance within an FDA-registered facility, and the company participates in E-Verify. The firm also offers CDMO services covering early-stage development engagement, regulatory strategy alignment, and long-term supply agreements with quality governance and sponsor transparency.

Assure Infusions generates revenue through three streams: direct sale of sterile IV fluids to hospitals under guaranteed supply commitments; 503B outsourcing services for compounded sterile preparations; and contract manufacturing for pharmaceutical sponsors. Pricing is quote-based and not publicly disclosed. Go-to-market is direct enterprise B2B sales with quality agreements and audit readiness, supported by a customer portal (my.assureiv.com) and a public licensed-states map that distinguishes currently-available jurisdictions from pending or in-process state licensures. The company maintains an organic social presence on LinkedIn, Facebook, and Instagram but discloses no funding history, headcount, management team, named customers, patents, or partnership agreements.

Name

Assure Infusions

Legal name

Assure Infusions

Website

https://assureiv.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

11–50 employees

Short description

Assure Infusions is a privately-held, FDA-registered 503B outsourcing facility and CDMO in Bartow, Florida that manufactures sterile IV fluids — Sodium Chloride, Dextrose, Lactated Ringers, and Sterile Water — in flexible bag configurations for sale to US hospitals and healthcare providers via direct enterprise contracts.

Ownership category

akta.pro rank

Product category

Sterile Injectable Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412), Plastics Bag and Pouch Manufacturing (326111)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

akta.pro secondary industries

Sterile & Aseptic Medical Packaging (Pouches, Wraps, Sterile Barriers) (IMALAIAB), Parenteral & Injectable Packaging Components (Stoppers, Seals, Syringes, Cartridges) (IMALAIAE)

Keywords

• Sterile IV fluids
• 503B outsourcing facility
• Pharmaceutical contract manufacturing
• IV bag manufacturing
• Hospital pharmaceutical supply

Headquarters

HQ city

Winter Haven

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Technology or R&D, Infrastructure, Personnel, Marketing or Sales

Revenue model

1. IV Fluid Manufacturing & Supply: Manufacturing and supply of sterile IV fluids (Sodium Chloride, Dextrose, Lactated Ringers, Sterile Water) to hospitals with guaranteed supply commitments
2. Contract Manufacturing Services: CDMO partnership services providing sterile manufacturing capabilities for pharmaceutical companies and healthcare providers under 503B outsourcing facility model
3. 503B Outsourcing Facility Services: 503B outsourcing facility providing compounded sterile preparations with cGMP compliance for hospital partnerships

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Assure Infusions manufactures and supplies sterile IV fluids (Sodium Chloride, Dextrose, Lactated Ringers, and Sterile Water for Injection) in pre-filled flexible IV bags in 250 mL, 500 mL, and 1000 mL configurations, produced in an FDA-registered, cGMP-compliant facility using fully automated, human touch-free fill-finish manufacturing with terminal sterilization. The company also operates as a 503B outsourcing facility and CDMO partner, offering contract manufacturing and long-term supply commitments to hospitals and pharmaceutical sponsors nationwide.

Product overview

Assure Infusions is a 503B Outsource Facility and CDMO (Contract Development and Manufacturing Organization) offering sterile IV fluid manufacturing solutions. The company's product portfolio centers on pre-filled IV bag solutions including Sodium Chloride, Dextrose, Lactated Ringers, and Sterile Water for Injection, available in 250 mL, 500 mL, and 1000 mL configurations. Services include Contract Manufacturing partnerships with early-stage development engagement, regulatory strategy alignment, and long-term supply agreements. All products are manufactured in a fully automated, human touch-free facility with terminal sterilization, operating under cGMP compliance within an FDA-registered facility.

Differentiator

Problem solved

Functional benefit

Products and services

• Sodium Chloride IV Solutions Sterile sodium chloride IV fluids available in 250 mL, 500 mL, and 1000 mL pre-filled flexible IV bag configurations, supplied to hospitals and healthcare providers for hospital readiness.
• Dextrose IV Solutions Sterile dextrose IV fluids available in 250 mL, 500 mL, and 1000 mL pre-filled flexible IV bag configurations, supplied to hospitals and healthcare providers for hospital readiness.
• Lactated Ringers IV Solutions Sterile lactated ringers IV fluids available in 250 mL, 500 mL, and 1000 mL pre-filled flexible IV bag configurations, supplied to hospitals and healthcare providers for hospital readiness.
• Sterile Water for Injection Sterile water for injection available in 250 mL, 500 mL, and 1000 mL pre-filled flexible IV bag configurations, supplied to hospitals and healthcare providers for hospital readiness.
• 503B Outsourcing Services FDA-registered 503B outsourcing facility providing sterile IV fluid manufacturing with cGMP compliance and guaranteed supply commitments for hospitals nationwide.
• Contract Manufacturing (CDMO) Services CDMO partnership services offering early-stage development engagement, regulatory strategy alignment, and long-term supply agreements with predictable timelines and quality governance for pharmaceutical sponsors.
• Pre-Filled IV Bag Manufacturing Fully automated fill-finish manufacturing in flexible IV bag systems with terminal sterilization for commercial-scale batch production in 250 mL, 500 mL, and 1000 mL configurations, manufactured in the USA with global parts.

Quantifiable outcome

• Unparalleled quality and consistency through fully automated, human touch-free manufacturing process

Named customers1 record

Segments1 record

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators3 records

Recent moves4 records

Expansion highlights4 records

Emerging players

• Amphastar Pharmaceuticals: U.S.-based specialty injectable manufacturer with in-house sterile manufacturing capabilities. Comparable on hospital-channel sterile injectable supply and as another scaled domestic entrant in this space.
• Catalent: Large CDMO with sterile fill-finish capabilities across injectable formats. Comparable on the CDMO side of Assure's business, competing for pharma sponsor sterile manufacturing partnerships.

Broad incumbents

• B. Braun Medical: Major manufacturer of IV solutions, flexible IV bags, and infusion therapy products with a long-standing U.S. hospital footprint. Directly competes with Assure's product set across Sodium Chloride, Lactated Ringers, and Dextrose.
• Baxter International: One of the largest global manufacturers of sterile IV solutions and flexible IV bags, with deep hospital contracts across the U.S. Sets the competitive benchmark on scale, pricing, and GPO access that Assure must beat to win share.
• Fresenius Kabi: Global manufacturer of IV solutions, clinical nutrition, and injectable pharmaceuticals with substantial U.S. hospital presence. Directly comparable product set across the foundational sterile IV fluids.
• Pfizer CentreOne (Hospira): Pfizer's contract manufacturing arm leveraging Hospira's legacy sterile injectable infrastructure. A scaled CDMO/sterile manufacturing peer that competes for pharma sponsor supply agreements.

Direct peers

• Hikma Pharmaceuticals: Generic injectable manufacturer with a growing U.S. sterile IV solutions portfolio. Comparable in providing hospital-channel sterile IV fluids and pursuing supply contracts for foundational IV solutions.
• Grand River Aseptic Manufacturing: U.S.-based aseptic fill-finish CDMO specializing in sterile injectable manufacturing with modern infrastructure. Closely comparable as a CDMO competitor pursuing sponsor and hospital sterile fill-finish contracts.
• ICU Medical: Manufacturer of IV solutions and infusion systems following the Hospira infusion systems acquisition. Direct product overlap in sterile IV fluids and bags with Assure's portfolio.
• Civica Inc: Non-profit, hospital-backed sterile injectable manufacturer explicitly built to address drug and IV fluid shortages with modern, cGMP-compliant facilities. Closely parallels Assure's positioning around supply reliability, modern infrastructure, and guaranteed hospital supply commitments.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/assureiv
• LinkedInlinkedin.com/company/assure-iv
• Instagraminstagram.com/assureiv

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Assure Infusions