Fagron Sterile Services

What Fagron Sterile Services does

Fagron Sterile Services US (FSS) is a DEA- and FDA-registered 503B pharmaceutical outsourcing facility headquartered at 8710 E 34th St N, Wichita, KS, producing compounded sterile preparations for hospitals, ambulatory surgery centers, IDNs, and physician offices across all 50 US states. The company operates through three state-of-the-art cGMP facilities in Wichita (KS), Boston (MA, acquired from Fresenius Kabi in July 2022), and Austin (TX), totaling 268K+ sq ft of capacity and 16 independent ISO 5 aseptic processing environments with dedicated HVAC systems and ULPA filtration. Core service lines include Critical Care/OR Anesthesia, Labor & Delivery, Ophthalmics, Pain Management, and Specialty Presentations, with featured products such as repackaged bevacizumab (Avastin) in Daikyo Crystal Zenith syringes, sterile LET Gel topical anesthetic, ready-to-administer IV bags, and RFID-enabled OR syringes via the Kit Check integration.

The technical stack is anchored by Groninger Flexicon peristaltic-pump filling systems installed inside Restricted Access Barrier Systems providing 3% fill accuracy, the UR3e robotic IV bag filler, the licensed Daikyo Crystal Zenith cyclic olefin polymer syringe with Flurotec barrier film (developed with West Pharmaceutical Services), and Groninger nested pre-sterilized syringes. Quality is supported by an in-house laboratory performing over 95% of sterility, particulate matter, potency, bacterial endotoxin, bioburden, and filter-integrity testing internally, with 100% of batches tested prior to release. RFID-enabled syringes embed Kit Check-compatible tags storing expiration date, lot, NDC, and refrigeration data for hospital inventory and diversion monitoring.

FSS generates revenue by selling compounded sterile preparations through a direct field-sales model backed by account representatives, structured GPO/IDN contracts (including a National Outsourced Compounded Preparations agreement with Premier, Inc. and access across all major US GPOs), and an e-commerce ordering platform at shop.fagronsterile.com. Pricing is quote-based and not publicly disclosed; committed customers are served through the Instant Ship Program, which delivers greater than 97% same-day shipping on orders placed before cutoff. The company is a wholly owned subsidiary of Fagron NV/S.A. (Euronext Brussels/Amsterdam: FAGR), a Belgian pharmaceutical compounding group operating in 35+ countries with 4,000+ employees; the US entity was originally founded as JCB Laboratories before its 2013 acquisition by Fagron. Distribution partnerships with Angels for Change under Project PROTECT support production of shortage-prone injectables such as Dextrose 70% and Sterile Water for Injection.

Name

Fagron Sterile Services

Legal name

Fagron Compounding Services, Inc.

Website

https://fagronsterile.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

101–250 employees

Short description

Fagron Sterile Services is a US FDA-registered 503B outsourcer producing compounded sterile preparations across critical care, ophthalmics, pain management, labor & delivery, and specialty presentations for 7,400+ hospitals, ambulatory surgery centers, and physician offices across all 50 states from cGMP facilities in Wichita, Boston, and Austin.

Ownership category

akta.pro rank

Headquarters

HQ city

Wichita

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Compounding Products: 503B outsourcing facility generating revenue through the sale of compounded sterile preparations including critical care medications, labor and delivery drugs, pain management solutions, ophthalmic products, and specialty medications. Products sold to healthcare facilities including hospitals, ambulatory surgery centers, and physician offices. Revenue derived from product sales with pricing based on specific formulations and quantities.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Fagron Sterile Services (FSS) is a FDA-registered 503B pharmaceutical outsourcing facility that manufactures and supplies compounded sterile preparations (CSPs) for hospitals, ambulatory surgery centers, and physician offices across all 50 U.S. states. Its product portfolio spans critical care/OR anesthesia, labor & delivery medications, ophthalmics, pain management injectables, and specialty presentations, produced under cGMP standards across three U.S. facilities (Wichita, Boston, and a new logistics center). The company operates 16 ISO 5 classified environments, performs in-house quality testing, and offers ready-to-administer presentations designed to reduce hospital pharmacy labor and improve patient safety.

Product overview

Fagron Sterile Services US (FSS) operates as a DEA and FDA-registered 503B outsourcing facility providing a vertically integrated portfolio of sterile compounded medications. The company offers five core service lines: Critical Care/OR Anesthesia preparations (including RFID-enabled syringes via Kit Check partnership), Labor & Delivery medications (oxyTOCIN, epidurals), Ophthalmics (with the revolutionary Avastin syringe using Daikyo Crystal Zenith technology from West Pharmaceutical Services), Pain Management preparations (bupivacaine, ropivacaine, fentanyl, hydromorphone), and Specialty Presentations (including the only sterile LET Gel). Products are manufactured through state-of-the-art cGMP-compliant operations at facilities in Wichita, KS and Boston, MA using Groninger automation and ISO-5 environments. The Instant Ship Program ensures same-day shipping on critical medications, with all batches tested for sterility, particulate matter, and potency before release.

Differentiator

Problem solved

Functional benefit

Brands

• AminoProtect: IV bags produced through cGMP-compliant operations for patient care support.
• LET Gel
• RFID-Enabled Syringes

Products and services

• Critical Care / OR Anesthesia Preparations Compounded sterile preparations for operating rooms and critical care units, designed to reduce hospital pharmacy compounding labor and improve patient safety. Targeted at hospital pharmacies and surgical teams.
• Labor & Delivery Preparations Sterile compounded medications formulated for obstetrics and labor & delivery units, supplied as ready-to-administer presentations to support maternal care workflows in hospitals.
• Repackaged Bevacizumab (Avastin) Injection Solution FDA-approved Avastin repackaged into single-dose vials under 503B oversight for ophthalmic intravitreal use, supplied to ophthalmology practices and ambulatory surgery centers.
• Ophthalmics Products Sterile compounded ophthalmic preparations including repackaged Avastin, supplied to ophthalmologists and ASCs for intravitreal injection procedures.
• Pain Management Preparations Sterile compounded injectable medications used for pain management in hospital and ambulatory care settings, prepared as ready-to-administer presentations.
• Specialty Presentations Specialty sterile compounded presentations including ready-to-administer IV bags and proprietary amino acid formulations designed for clinical nutrition support.
• RFID-Enabled OR Syringes Sterile pre-filled operating room syringes enabled with RFID technology for tracking, automated kit replenishment, and documentation, integrated through the Kit Check partnership. Targeted at hospital OR pharmacies.
• Ready-to-Administer IV Bags Premixed sterile IV bags supplied to hospitals in ready-to-administer form, eliminating in-hospital compounding steps. Includes proprietary formulations such as AminoProtect and Phenylephrine HCl IV bags.
• AminoProtect (Proprietary Amino Acid IV Bag) Proprietary sterile compounded amino acid IV bag product produced on FSS's UR3e robotic IV bag filler for clinical nutrition applications.
• Phenylephrine HCl 25 mg per 250 mL IV Bag Sterile ready-to-administer Phenylephrine IV bag formulation produced at the new Southwest Florida (SWFI) facility, expanding FSS's ready-to-administer product line.

Quantifiable outcome

• Greater than 97% same-day shipping on orders placed before cutoff times
• +4 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature7 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Angels for ChangecoreStrategic or Co-development Partner · 29 May 2025FSS received 2025 Project PROTECT grant from Angels for Change to produce sterile water for injection (SWFI) in response to shortages caused by 2024 hurricanes. Previously received 2023 grant for Dextrose production. Partnership aims to enhance emergency preparedness and ensure continuous patient care amid future disruptions. Angels for Change is a patient advocacy organization dedicated to ending drug shortages through Project PROTECT grant program supporting domestic manufacturing of critical injectable medicines.
• Premier, Inc.coreChannel Partner/ Reseller/ Distributor · 22 January 2025FSS awarded National Outsourced Compounded Preparations agreement with Premier, Inc. This GPO partnership provides contracted pricing and terms for FSS products and services available to Premier member healthcare facilities across the United States.
• Angels for ChangecoreStrategic or Co-development Partner · 7 September 2023FSS received 2023 Project PROTECT grant recognizing its role in safeguarding access to Dextrose, an essential medication, amidst drug shortages. Partnership supports healthcare supply chain resiliency and ensures availability of sterile medications across all 50 states.
• End Drug Shortage Alliance (EDSA)minorStrategic or Co-development Partner · 1 January 2023Fagron is a proud member of EDSA collaborating across the industry to support the end of drug shortages. Partnership focuses on building a resilient healthcare supply chain through industry collaboration and transparency.
• Fresenius KabicoreOthers · 5 July 2022FSS acquired a 503B outsourcing facility in Boston from Fresenius Kabi. Transaction covered all operational aspects including customers, suppliers, approximately 80 employees, and a supply agreement with Fresenius Kabi. Acquisition supports strategic objective of becoming leading global platform for sterile outsourcing services and strengthens East Coast geographic presence.
• GroningercoreTechnology or Integration · 1 January 2022Groninger filling machines used for state-of-the-art syringe processing. Groninger is recognized as a global leader in syringe processing with nested pre-sterilized syringes preventing possibilities of microbiological contamination. Machines provide 3% filling accuracy and are installed inside RABS systems providing Class A (ISO-5) environment.
• Kit CheckcoreTechnology or Integration · 8 December 2021Strategic partnership to launch RFID-enabled OR syringes. FSS manufactures products embedded with RFID tags compatible with Kit Check scanning technology. RFID tags store information for each dose including expiration date, lot number, NDC, and refrigeration date. Partnership enables item-level visibility, optimized inventory management, and medication safety for hospital customers. Portfolio expanded to include products from both Wichita, KS and Boston, MA facilities.
• West Pharmaceutical Services, Inc.coreTechnology or Integration · 1 January 2020Collaboration to develop the revolutionary Daikyo Crystal Zenith® cyclic olefin polymer syringe for repackaged bevacizumab (Avastin®). West provides the syringe technology featuring an inert, low-leachable environment suitable for long-term storage of biologics. This collaboration created the first sterile compounded biologic presentation specifically configured for clean container and automated filling process.

Scale indicators14 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Olympia Pharmaceuticals: 503B-registered outsourcing facility producing sterile compounded preparations with similar critical care, pain management, and specialty product portfolios to FSS. Direct sales to hospitals and healthcare systems.
• Avet Pharmaceuticals: Specialty pharmaceutical manufacturer and 503B compounder with injectable generic and compounded sterile preparations. Competes with FSS in hospital-channel sterile injectable supply.
• Central Admixture Pharmacy Services (CAPS): B. Braun-owned 503B outsourcing network serving hospitals with compounded sterile preparations. Operates multiple regional facilities, overlapping directly with FSS's critical care, OR, and IV admixture offerings.
• QuVa Pharma: One of the largest 503B outsourcing facilities in the US producing sterile compounded preparations for hospitals and surgery centers. Direct competitor to FSS across critical care, OR anesthesia, and ready-to-administer syringes/IV bags.
• Leiters Health: FDA-registered 503B outsourcing facility focused on sterile preparations for hospitals and ophthalmology. Comparable in scale and product overlap, particularly in ophthalmic compounded preparations and ready-to-administer syringes.
• Wells Pharma: 503B outsourcing facility producing sterile compounded medications for hospitals, with overlapping concentrations in critical care and pain management sterile preparations.

Broad incumbents

• Catalent: Large-scale CDMO providing contract development and manufacturing for sterile injectables and biologics. Broader scope than FSS but competes for outsourced sterile manufacturing capacity in pharma customer portfolios.
• B. Braun Medical: Parent of CAPS (503B) and large medical device/IV solution manufacturer with significant US pharmaceutical manufacturing footprint. Provides vertical scale advantage vs. FSS in sterile hospital-channel supply.
• Civica Rx: Nonprofit health system-owned pharmaceutical manufacturer focused on ending drug shortages via domestic production. Adjacent to FSS's 503B operations but broader mission with multiple manufacturing sites outside pure compounding.
• Patheon (Thermo Fisher Scientific): Global CDMO with sterile injectable commercial manufacturing services under Thermo Fisher. Competes for outsourced fill-finish work and serves similar pharma/hospital customers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat7 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/fagron
• Xx.com/FagronSterile

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 record

Funding overview

Funding rounds2 records

Investors1 record

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 Fagron Sterile Services