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Last updated: March 2026
This directory lists 50 prefilled syringe manufacturers across the United States, from integrated CDMOs offering comprehensive drug product development and aseptic fill/finish for complex biologics to specialized contract fillers focusing on high-volume, precision filling into pre-sterilized primary containers.
Buyers in this space are typically solving problems related to achieving precise and convenient drug delivery, extending product shelf-life, and simplifying administration for patients. This often involves navigating the complexities of high-viscosity formulations, ensuring robust container closure integrity (CCI) throughout the product's life, and managing the intricate regulatory pathways for parenteral drug-device combination products.
Supplier types vary significantly, ranging from large, multinational contract development and manufacturing organizations (CDMOs) that can handle everything from API synthesis to final device assembly and packaging, to smaller, more nimble specialty contract manufacturers focused solely on sterile fill-finish for specific primary container types or drug classes like small molecules or biosimilars.
Before engaging, buyers should have a clear understanding of their drug product's stability profile, target patient population, desired device features, and most critically, a robust regulatory strategy. Suppliers, in turn, expect detailed user requirements specifications (URS), comprehensive drug substance and product stability data, and clear communication regarding projected volumes and timelines to accurately assess project feasibility and provide realistic proposals.
A notable trend in the prefilled syringe market is the increasing demand for customizable integrated drug delivery systems that improve patient adherence and safety. This push often involves advanced primary container materials beyond traditional glass, such as cyclic olefin polymer (COP) syringes, and incorporating smart device features, driving manufacturers to invest heavily in both material science expertise and sophisticated automated assembly capabilities.
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50 companies nationwide
Based in Durham, NC, Accord Healthcare is a generic pharmaceutical company. They manufacture and provide a range of pharmaceutical products, including pre-filled syringes for various medications. The company focuses on delivering high-quality, timely, and affordable solutions to meet medical needs.
Based in Sunnyvale, CA, AD Surgical is a medical device manufacturer specializing in a range of surgical products. They produce medical supplies including surgical sutures, surgical instruments, and prefilled saline IV flush syringes. Their products are designed for convenience and efficiency in medical settings.
Based in Charlottesville, VA, Afton Scientific provides comprehensive aseptic contract manufacturing and fill-finish services. They specialize in sterile filling and processing for pharmaceutical biologics and small molecules. The company ensures product integrity through advanced laboratory services and rigorous quality assurance from its FDA-inspected facilities.
Based in Brooksville, FL, American Injectables is an FDA-approved U.S.-based CDMO specializing in sterile injectable manufacturing. The company offers services for vial and syringe production, including advanced fill-finish lines, supporting programs from early development through commercial supply.
BD (Becton, Dickinson and Company) is a medical technology company specializing in prefillable syringe systems. Its portfolio is designed to enhance drug stability, improve dosing accuracy, and promote patient safety across various therapeutic areas, advancing global health through innovative solutions.
Civica Rx is a pharmaceutical company that manufactures essential generic medications and affordable insulin. It operates a sterile injectable manufacturing facility in the US, providing over 70 medications to hospitals to address drug shortages and high prices, including products likely utilizing prefilled syringe technology.
CODAN US Corporation, a world-class manufacturer based in Santa Ana, CA, specializes in high-quality single-use syringes designed for precise control and accurate dosage. They also produce various medical devices, including IV administration sets, transfusion sets, extension sets, and withdrawal preparation systems.
Credence MedSystems provides innovative injectable drug delivery solutions and devices for pharmaceutical and biotechnology manufacturers. They offer drug delivery systems that address evolving industry needs and challenges, enabling prefilled pharmaceutical applications.
Based in Auburn, NY, Currier Plastics is an ISO 13485 certified and FDA registered contract manufacturer. They specialize in custom injection and blow molding, producing high-quality plastic components for the healthcare market. With US facilities, Currier provides precision manufacturing for medical parts.
Based in Richmond, CA, JOINN Bio is a global multi-site biologics CDMO provider. They offer comprehensive contract development and manufacturing services, including cell line and process development, cGMP manufacturing, and fill and finish for drug products, specializing in complex biologics modalities.
Kindeva CDMO is a drug delivery Contract Development and Manufacturing Organization specializing in sterile injectable solutions. The company offers comprehensive services from formulation to final assembly, utilizing dedicated aseptic operations and fill suites at its Bridgeton facility. Kindeva CDMO supports clients from development through commercial manufacturing.
Latitude Pharmaceuticals Inc. provides GLP and GMP compliant manufacturing and analytical testing services for global biotech and pharmaceutical companies. Specializing in complex drug formulation and delivery systems, they offer support from formulation development through the manufacture of clinical trial material and GMP release testing.
Based in Santa Ana, CA, McGuff Pharmaceuticals is an FDA-inspected sterile liquid fill contract manufacturer. They offer cGMP compliant services for brand and generic drug products, including private labels. The company supports clinical trials, providing R&D, product development, and regulatory expertise.
Merit OEM manufactures superior molded parts and components, including pre-filled syringes. Their Merit COP Syringe is a recognized product in the pre-filled syringe market, designed with advanced features to prevent moisture loss. They offer customized manufacturing solutions, including coating capabilities and specialized sensor technology.
MK Fluidic Systems designs and manufactures precision syringes, probes, rotary valves, and tubing assemblies. Serving the Life Science, Diagnostic, and Analytical industries, the company provides custom fluidic products and components. Their durable products are designed to perform accurately and reliably, meeting specific customer requirements for various applications.
Based in Sacramento, CA, Nivagen Pharmaceuticals is a specialty pharma company manufacturing sterile injectables. Their state-of-the-art California facility produces various dosage forms, including prefilled syringes (PFS), vials, and cartridges. Nivagen also develops and markets generics, specialty drugs, and offers 503B compounding services.
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) focused on pharmaceutical and biotech services. They specialize in integrated prefilled syringe manufacturing for clinical and commercial programs, offering sterile fill-finish and secondary packaging. PCI enhances dosing accuracy and simplifies trial execution for injectables.
Pii, a Jabil company, is a contract development and manufacturing organization (CDMO) specializing in complex drug products. They offer aseptic manufacturing services, including prefilled syringe contract manufacturing, with a focus on patient ease and precise dosing. Pii delivers customized solutions for clinical and commercial supply.
Pro-Tech Design & Manufacturing provides comprehensive medical device contract packaging, assembly, and outsourcing services. Based in Santa Fe Springs, CA, they specialize in liquid filling for syringes, vials, and tubes, alongside chemical compounding. This FDA and ISO 13485 registered company offers end-to-end solutions from multiple US locations.
Pyramid Pharma Services, Inc. specializes in contract manufacturing services, focusing on vial and prefilled syringe filling. Since their inaugural commercial manufacturing run in 2015, the company has provided these specialized services for various commercial pharmaceutical products. They offer dedicated filling solutions for the pharmaceutical industry.
Pfizer is a pharmaceutical company that provides ready-to-use products for hospitals, including prefilled syringes like NEXJECT® and CARPUJECT®. These syringes are designed for efficient drug delivery, featuring easy-to-read labels and needleless technology to enhance patient safety, reduce medication errors, and protect staff.
Sharp Services specializes in isolator-based sterile manufacturing and fill/finish services. They process drug products into vials, cartridges, and prefilled syringes, supporting clients from clinical phase through small to mid-scale commercial production. The company operates GMP sites in the US, providing comprehensive sterile drug product solutions.
Based in Arlington, WA, TSK Laboratory America designs and manufactures high-quality ophthalmic needles, syringes, and injection devices. They provide premium needle solutions globally, aiming to enhance the precision and perfection of injections for professionals worldwide.
Singota Solutions, a CDMO based in Bloomington, Indiana, specializes in aseptic injectable manufacturing for pharmaceutical, animal health, and biotechnology clients. They provide small-batch aseptic filling services utilizing advanced robotic SA25 technology, alongside drug development and supply chain management.
Based in Auburn, AL, SiO2 Materials Science is a primary packaging company specializing in custom prefilled syringes. They manufacture staked needle syringes for auto-injectors, utilizing proprietary vyterial™ coating technology for enhanced barrier properties and durability, ideal for high viscosity drugs.
Terumo Medical Corporation, headquartered in Elkton, MD, is a prominent manufacturer of medical devices and supplies. The company conducts its own research, development, and manufacturing operations, producing a diverse portfolio of healthcare products, including various types of syringes. They serve the global medical and pharmaceutical industries.
Trademark Plastics (TPI) is a specialized medical device injection molding company offering turnkey solutions for the healthcare industry. They provide rapid prototyping to validated mass production from their 100,000 sq. ft. facility, which includes class 8 cleanrooms and 51 injection molding machines. TPI is ISO 9001 and 13485 certified.
Xseer Pharmaceuticals is a U.S.-based, FDA-registered Contract Development and Manufacturing Organization (CDMO) specializing in cGMP-compliant production of sterile injectables, non-sterile liquids, and complex formulations. They support clients from preclinical development to commercial supply, delivering high-quality pharmaceutical products.
Ajinomoto Bio-Pharma Services is a contract development and manufacturing organization (CDMO) specializing in sterile fill-finish services for small molecules, gene therapies, and large molecules. They utilize advanced isolated barrier technology to ensure sterility for drug product manufacturing. The company also offers analytical and development services.
Fresenius Kabi CMO offers contract manufacturing for sterile pharmaceuticals, specializing in filling and finishing, aseptic processing, and terminal sterilization. Their capabilities include prefilled syringes, vials, IV bags, and ampoules. They serve biologics and small molecule products from their advanced production centers, including US facilities.
Gerresheimer manufactures premium prefillable glass syringes crafted for optimal drug stability and smooth delivery. Their products prioritize enhanced patient comfort and are well-suited for sensitive pharmaceutical formulations. The company provides a broad portfolio of pharmaceutical primary packaging and comprehensive drug delivery systems.
Based in Marietta, GA, Owen Mumford designs and manufactures innovative medical devices and injectable drug delivery systems. They develop pioneering products and custom solutions for leading pharmaceutical and diagnostic companies, specializing in autoinjectors and systems for chronic diseases.
Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) with US facilities, notably in Lexington, KY. They specialize in sterile injectables, providing comprehensive formulation development, sterile compounding, and fill/finish services. The company partners with pharmaceutical and biotech clients.
Based in Putnam, CT, Sever Pharma Solutions is a CDMO specializing in high-potent and cytotoxic drug products. The company offers state-of-the-art manufacturing for prefilled syringes and autoinjector assembly, including aseptic fill and finish capabilities with automated visual inspection for pharmaceutical clients.
Based in Carlsbad, CA, Argonaut Manufacturing Services is a contract manufacturer specializing in aseptic fill-finish for vials, syringes, and cartridges. They provide comprehensive services for drug products, including drug-device combination products, utilizing isolator-based sterile manufacturing for life sciences and IVD clients.
August Bioservices specializes in high-quality, scalable sterile injectable manufacturing and integrated drug development. Based in Nashville, TN, the company provides end-to-end services, supporting clients from early-phase to commercial production. They leverage state-of-the-art technology and cutting-edge science for comprehensive pharmaceutical solutions.
Catalent Biologics operates as a global CDMO partner, providing comprehensive development and manufacturing services for biologics, cell and gene therapies. They specialize in fill/finish services, formulating and finishing sterile products into final syringes or cartridges for commercial supply.
Comar is a contract manufacturer providing medical and packaging solutions, including custom-designed primary packaging and dispensing solutions. The company produces premium plastic oral syringes, tested and used by major pharmaceutical companies. Comar offers expertise in transforming concepts into market-ready solutions for health and wellness applications.
Based in Wichita, KS, Fagron Sterile Services US is an FDA-registered 503B outsourcing facility. It specializes in pharmaceutical manufacturing and repackaging of high-quality sterile medications, including ready-to-administer prefilled syringes. The company utilizes automated technology, supporting patient safety and supply chain resiliency.
Based in Durham, NC, Gilero partners with healthcare companies to develop innovative medical devices and drug delivery systems. As a CDMO, it offers tailored solutions from concept to global-scale production, including the design and development of sterile, prefilled luer lock syringe devices based on glass cartridges.
Grand River Aseptic Manufacturing (GRAM) is a contract development and manufacturing organization (CDMO) based in Grand Rapids, MI. They specialize in sterile injectable fill-and-finish services for liquid and lyophilized vials, syringes, and cartridges. GRAM supports pharmaceutical and biotechnology partners, offering tailored solutions for autoinjectors and on-body drug delivery systems.
Based in Ivyland, PA, Lyophilization Technology, Inc. is a Contract Development & Manufacturing Organization (CDMO). They provide aseptic filling and lyophilization services for health care products, including therapeutic injections and vaccines. Their capabilities extend to manufacturing into vials, cartridges, and prefilled syringes for clinical trial materials.
Patheon, a Thermo Fisher Scientific brand, provides comprehensive contract development and manufacturing (CDMO) services, including flexible sterile fill-finish solutions for a variety of molecules. They specialize in parenteral dosage formats, explicitly offering services for prefilled syringes and related secondary packaging and assembly across their global and US-based facilities.
Alcami Corporation is a US-based contract development and manufacturing organization (CDMO) with 45+ years of experience. They provide comprehensive sterile fill-finish manufacturing for pharmaceuticals and biologics. Alcami specializes in prefilled syringes, offering capabilities for 1mL long, 1mL standard, and 2.25mL syringe formats.
Curia Global, Inc. is a global CDMO with over 30 years of experience in drug discovery, development, and manufacturing. It specializes in sterile drug product and biologics manufacturing, also offering small molecule and generic API services. Curia provides flexible, scalable solutions, leveraging deep scientific expertise to accelerate product delivery for clients.
Based in Chicago, IL, Nemera designs and manufactures comprehensive drug delivery device solutions. The company partners with customers to develop innovative combination products, focusing on maximizing treatment efficacy and supporting device strategies for various pharmaceutical applications.
Phillips Medisize is a contract development and manufacturing organization (CDMO) that designs and manufactures products for the pharmaceutical, medtech, and in vitro diagnostic industries. The company specializes in providing precision-engineered autoinjector solutions for patient-centric applications.
Based in Bloomington, IN, Simtra BioPharma Solutions is a contract development and manufacturing organization specializing in sterile injectable products. They offer prefilled syringe production capabilities, including both low-speed and high-speed, high-volume syringe filling services, for clinical and commercial pharmaceutical needs.
Viant Medical provides comprehensive design, development, and manufacturing capabilities for innovative drug delivery solutions and medical devices. Focusing on safety, efficiency, and patient comfort, the company supports the MedTech industry with interventional device expertise and advanced manufacturing services.
Based in Carlsbad, CA, Safety Syringes Inc D is a company specializing in the development and manufacturing of innovative syringe products. They provide advanced syringe solutions, directly serving the medical and pharmaceutical sectors as a manufacturer.
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A prefilled syringe manufacturer goes beyond sterile filling; they specialize in the complex interplay of drug product stability within a specific primary container (the syringe barrel, plunger, needle shield) and its associated functional performance. This includes expertise in plunger glide force consistency, silicone oil application, container closure integrity (CCI), and often, the regulatory pathway for drug-device combination products, which standard sterile fill-finish operations may not cover comprehensively.
E&L studies are critically important for prefilled syringes because the drug product is in direct, prolonged contact with multiple device components (glass/polymer barrel, plunger stopper, needle glue, needle shield). These studies identify and quantify any substances that could migrate from the container/device into the drug product, potentially impacting drug stability, efficacy, or patient safety. Regulatory bodies require robust E&L data to ensure the drug-device combination product is safe and stable over its shelf life, often dictating material selection and sterilization methods early in development.
Polymer syringes (e.g., Cyclic Olefin Copolymer/Polymer) are often chosen for sensitive biologic drug products due to their reduced risk of breakage, lower extractables (e.g., tungsten, delamination), and higher pH resistance compared to glass. From a manufacturing standpoint, working with polymer syringes requires different handling, specialized filling lines with adjusted parameters for material properties, and specific quality control checks for dimensional stability and potential static electricity issues, which are distinct from glass syringe processes.
Beyond general cGMP compliance, a manufacturer handling biologics in prefilled syringes must demonstrate stringent control over cold chain management, robust environmental monitoring for aseptic processes (e.g., Grade A/B classification), and validated sterilization processes for all components. Their quality system should also have strong deviation management, change control, and CAPA processes tailored to drug-device combination products, ensuring traceability of all raw materials, components, and critical process parameters to maintain product integrity and patient safety.