Based in Paso Robles, CA, Acme Vial & Glass is a long-standing US manufacturer of top quality glass vials. Established in 1942, the company provides a wide array of stock glass vials and closures, serving various commercial and industrial applications.
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Ampoule Manufacturers
Last updated: February 2026
This directory lists 52 ampoule manufacturers across the United States, from contract development and manufacturing organizations (CDMOs) specializing in aseptic filling to high-volume blow-fill-seal operations.
Buyers are solving critical problems like ensuring precise dosing for sensitive APIs, preventing particulate contamination, or achieving regulatory compliance for new drug applications. This involves navigating complexities like pull-seal vs. tip-seal ampoule formats, verifying cleanroom classification suitability, and managing drug-container interaction risks.
The types of ampoule manufacturers vary significantly. Some specialize in small-batch, lyo-compatible ampoules for early-stage clinical trials, offering extensive formulation support and analytical services. Others focus on high-speed, large-volume production of form-fill-seal ampoules for established over-the-counter or generic pharmaceuticals, emphasizing cost efficiency and scale. A distinct segment also provides specialized capabilities for potent compounds or biologics, requiring dedicated equipment and containment strategies.
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Company Directory
52 companies nationwide
Adams & Chittenden Scientific Glass, based in Berkeley, CA, manufactures custom borosilicate laboratory glassware and glass tools for science and industry. They produce OEM glass parts and custom apparatus for biotech, pharmaceutical, electrochemical, and general research and production. Providing cost-effective, high-quality solutions, they ship custom glassware worldwide.
Based in Charlottesville, VA, Afton Scientific specializes in aseptic manufacturing and fill-finish services for sterile injectables. They provide high-precision, contaminant-free sterile filling for biologics and small molecules through comprehensive contract manufacturing solutions, supported by advanced laboratory services and rigorous quality assurance.
Based in Apex, NC, ApiJect specializes in Blow-Fill-Seal (BFS) container technology for sterile prefilled injectors. They develop and manufacture BFS containers for drug delivery, offering affordable, accessible, and sustainable solutions for pharmaceutical injectables. A new generic injectable drug manufacturing facility is set to open in 2026.
Based in El Cajon, CA, Calbiotech is an FDA-registered CDMO specializing in IVD contract manufacturing. They offer reagent formulation, aliquoting, and fill/finish services, including bottling, labeling, and packaging for diagnostic kit production. With 25+ years of experience, they provide scalable manufacturing solutions.
Based in Aubrey, TX, Carter Glassblowing Inc. fabricates custom quartz ampoules and plugs. They provide high-quality quartzware crucial for processing sensors and infrared glass in the Optics industry. The company serves diverse processing sectors, developing strategies to create quality quartzware that consistently exceeds customer expectations.
Design Realized manufactures high-purity fused silica quartz tubes, ampoules, and custom-shaped components for research laboratories. They specialize in custom-grown laser crystals, advanced optical materials, and bespoke scientific equipment. Additionally, the company provides 3D printing services and MEMS fabrication for R&D applications.
Based in Millville, NJ, DWK Life Sciences manufactures high-quality glass ampoules. These products are designed for optimal storage and safety, serving the pharmaceutical industry for packaging both injectable and oral drugs. The company focuses on reliable solutions for critical drug containment.
Ez-Life Pharmaceuticals, an FDA-registered contract manufacturer in Atlanta, GA, specializes in pharmaceutical manufacturing and re-packaging. They handle diverse formulations like topicals, liquids, and semi-solids. Operating an ISO Clean Room, the company provides cGMP compliant processes with low minimum order quantities.
Based in Grass Valley, CA, Farlow's Scientific Glassblowing, Inc. creates high-quality custom glass parts for industrial and medical applications. They specialize in intricate designs and tight tolerances, offering custom glassware from prototype development to full production runs. They serve industries like aquaculture and environmental testing.
Based in New York, Impacked Packaging manufactures a variety of plastic ampoules and resealable vials. They provide customizable packaging solutions designed to meet specific project requirements for diverse industrial and commercial needs.
Based in Doylestown, PA, J Penner Corporation specializes in custom single-use and crushable glass ampoule filling. They provide hermetically sealed liquid dispensing for medical and industrial applications. The company also offers custom ampoule packaging solutions with true no-drip liquid delivery innovations.
Based in San Diego, CA, Latitude Pharmaceuticals Inc. offers GLP and GMP compliant manufacturing and analytical testing services for biotech and pharmaceutical companies. They specialize in formulation development, drug delivery systems, and the manufacture of clinical trial material, including vials and prefilled syringes.
Based in Boca Raton, FL, LF of America provides turnkey packaging manufacturing, formulation, and contract filling services for personal care and OTC products. They specialize in unit dose packaging, including customizable ampoules, with all services performed in an ISO 8 Clean Room following Cosmetic GMP guidelines.
Based in West Columbia, SC, Nephron Pharmaceuticals specializes in sterile pharmaceutical manufacturing. They utilize advanced Blow-Fill-Seal technology to produce pre-filled medications, including inhalation solutions and suspension products. The company provides high-quality sterile medications for hospitals and medical facilities across the United States.
Based in Salt Lake City, UT, Nutrix USA is an NSF ISO certified contract manufacturer of personal care products. They offer private label and wholesale packaging solutions, including unit dose sample packs, for cosmetics, skin care, oral care, and essential oils. The company provides product development from their FDA registered facility.
Based in Philadelphia, PA, PCI Pharma Services is a contract development and manufacturing organization (CDMO) for the pharmaceutical industry. They offer comprehensive sterile fill-finish services for injectables, including ampoules, vials, and cartridges. Leveraging automated lines, they support the full product lifecycle with scalable solutions for clinical and commercial supply.
Based in Solana Beach, CA, PiSA USA provides comprehensive pharmaceutical and medical device contract manufacturing. They specialize in aseptic blow-fill-sealing, injectables, lyophilized powders, and packaging solutions. The company offers full product development, ETO sterilization, and manufacturing for combination products, serving the pharmaceutical industry.
Phoenix Glass is a US manufacturer of glass vials and containers, operating from its New Jersey facility. They produce millions of vials for fragrance, cosmetic, diagnostic, and lab science industries. The company also offers decorating services, plastic closures, and pumps, serving over 500 unique customers.
RetiRacks specializes in providing customized Quartz Ampoules and Plugs. These products are designed for the processing of sensors and infrared glass, primarily serving the specialized needs of the Optics industry.
Richland Glass manufactures standard and custom glass products for electronics, industrial, and scientific applications. They specialize in precision electronic glass and quartz components, including tubular glass vials for pharmaceutical packaging. Services include direct draw, re-drawing, cutting, and glass-to-metal sealing.
Based in Lower Gwynedd, PA, Richman Chemical Inc. offers custom glass ampoule filling and sealing services. They provide versatile solutions for safely containing a variety of substances, serving industrial and commercial clients with their specialized manufacturing capabilities.
Based in Columbia, SC, Ritedose is a contract development and manufacturing organization (CDMO) specializing in sterile Blow-Fill-Seal (BFS) technology. They produce unit dose solutions for ophthalmic and respiratory pharmaceutical products, offering comprehensive manufacturing services with an emphasis on high-quality therapeutics.
Robinson Pharma, Inc., a Santa Ana, CA contract manufacturer, offers over 30 years of experience in supplement production. They specialize in custom formulation, private labeling, and packaging for diverse product types including softgels, capsules, powders, and liquids. The company provides a substantial annual capacity for liquid ampoule manufacturing.
Alfasigma, based in Bedminster, NJ, is a contract manufacturing organization providing outsourcing services for pharmaceutical forms. The company manufactures nearly all pharmaceutical forms, including sterile injectable products like ampoules, for the pharmaceutical industry. They offer comprehensive services for various drug products.
Fresenius Kabi Contract Manufacturing provides sterile fill and finish services, specializing in ampoule manufacturing for sterile solutions and emulsions. They offer aseptic processing and terminal sterilization capabilities. With state-of-the-art production centers in North America and globally, the company focuses on quality and compliance, delivering tailored solutions for pharmaceutical partners.
Delpharm operates multiple manufacturing facilities in the United States, specializing in the production of sterile liquid ampoules for the pharmaceutical industry. As a Contract Development and Manufacturing Organization (CDMO), they produce ampoules in various sizes, from 1ml to 25ml.
Gerresheimer manufactures high-quality pharmaceutical ampoules from type I pharma glass, offering a broad portfolio of primary packaging solutions. Operating globally with US facilities, including in Denver, CO, the company employs modern technologies to meet stringent hygiene and safety standards. Gerresheimer is committed to ambitious sustainability goals.
Based in Wilmington, NC, Heraeus Covantics specializes in large-scale custom glass manufacturing. The company leverages lean manufacturing and automation at its facility to produce high-quality, specialized glass products for industrial clients. Their capabilities are well-suited for crafting custom glass components and potential ampoule manufacturing applications.
Hikma Pharmaceuticals provides manufacturing services for high-quality injectable, oral, and respiratory products. The company leverages its state-of-the-art facilities to offer reliable and flexible manufacturing capabilities for diverse pharmaceutical needs, including ampoules.
Based in West Palm Beach, FL, Horizon Pharmaceuticals, Inc. is a CDMO specializing in the development, manufacture, and lifecycle management of pharmaceutical products. The company focuses on blow-fill-seal (BFS) technology to produce sterile, unit-dose liquid medications, providing comprehensive contract manufacturing services for the pharmaceutical industry.
Based in St. Louis, MO, Accu-Glass, LLC engineers and manufactures precision glass tube products. Since 1960, they have specialized in custom solutions for medical, laboratory, and pharmaceutical packaging industries, including glass ampoules, microbore tubing, and calibrated micropipettes. Accu-Glass is dedicated to quality and rapid service.
Arcade Beauty is a global manufacturing partner providing turnkey beauty solutions, including packaging, fragrance blending, bulk manufacturing, and filling and assembly for various product formats. They specialize in ampoules for serums and oils, offering capacities from 1.5ml to 11ml. The company operates multiple manufacturing facilities across the United States.
Based in Vineland, NJ, Bellco Glass, Inc. engineers and manufactures premium laboratory glassware, including freeze-dry ampoules and cell culture systems, since 1936. The family-owned company serves the biotechnology industry, from academic research to biopharma production, and offers custom configurations.
Based in Grand Rapids, MI, Grand River Aseptic Manufacturing is a CDMO specializing in sterile injectable fill-and-finish services. They produce liquid and lyophilized vials, syringes, and cartridges for pharmaceutical and biotechnology partners, supporting clinical trials and commercialization.
Founded in 1976, James Alexander Corporation specializes in contract filling services and single-use packaging solutions. They are recognized for innovations in glass ampoule packaging and plastic ampoule delivery systems, including crushable glass ampoules, plastic ampoules, and snap-top vials for various applications.
Jubilant Pharma provides sterile manufacturing services for liquid and lyophilized vials, serving pharmaceutical clients from clinical trials through commercial production. Its US facility in Spokane, Washington, supports these critical manufacturing needs, offering specialized expertise in injectable drug product manufacturing.
Based in Spokane, WA, Jubilant HollisterStier is a contract manufacturing partner specializing in sterile fill-finish services for pharmaceutical products. They offer comprehensive solutions, including sterile filling into ampoules, vials, and syringes, lyophilization, inspection, and packaging for clinical to commercial scale projects.
Based in Claremont, CA, King Precision Glass, Inc. manufactures premium specialty glass tubing. They provide drawing and redrawing services for custom tubing, cane, and various forms with sealed ends. Serving medical device manufacturing, electronics, and research, they offer solutions from prototypes to large-scale production runs.
Based in Vineland, NJ, Precision Electronic Glass specializes in custom glass and quartz component fabrication. They provide precision bore glass tubing and other customized glass products, engineered to exact specifications. Capabilities include grinding, polishing, finishing, laser engraving, and CNC machining for diverse industrial applications.
Based in Orchard Park, NY, Polymer Medical specializes in the consistent manufacturing of plastic ampoules. The company's personnel have a long track record, demonstrating deep understanding of tool transfer and production methodologies for these intricate medical devices.
Röchling US, part of the Röchling Group, specializes in developing and producing customized plastic primary packaging solutions. They serve the Pharma, Diagnostics, and Medical Technology sectors, offering high functional reliability and easy, safe handling components tailored to client needs.
Based in Spokane, WA, Silgan Unicep specializes in contract filling and packaging. They offer custom unit-dose blow-fill-seal dispensers, effectively manufacturing ampoules for liquids and gels. Serving diagnostics, animal health, oral, and consumer healthcare, they are FDA registered, ISO13485:2016, and cGMP compliant.
Based in Westwood, NJ, Sonic Packaging Industries provides single-use unit dose packaging services. The company offers specialized filling and packaging options for various products, including topical and oral applications, supporting clients from concept to market.
Unither Pharmaceuticals, based in San Diego, CA, is a contract manufacturer for liquid pharmaceutical products. They offer comprehensive services, from formulation to manufacturing, utilizing advanced Blow-Fill-Seal (BFS) technology. Specializing in sterile, preservative-free multidose applications, Unither delivers diverse liquid product solutions for the health industry.
Alcami is a US-based contract development and manufacturing organization (CDMO) specializing in comprehensive sterile fill-finish manufacturing services for pharmaceuticals and biologics. They provide drug product manufacturing, including prefilled syringes, along with integrated lab services and cGMP pharma storage. Alcami supports drug advancement from development to delivery.
Argonaut Manufacturing Services provides full-service contract manufacturing for aseptic fill-finish. They specialize in sterile filling of vials, syringes, and cartridges, offering comprehensive solutions for the biopharmaceutical and medical device sectors. Their services ensure high-quality, sterile packaging.
Based in Temecula, CA, MOS Plastics, a KS Group Company, specializes in custom plastic injection molding for medical devices, diagnostic devices, and regulated packaging. They offer cleanroom manufacturing, automation assembly, and design engineering services for complex plastic components and specialized containers.
Nipro manufactures primary pharmaceutical packaging solutions, including glass ampoules, vials, cartridges, and syringes. With global operations and U.S. manufacturing facilities, they serve the pharmaceutical industry by providing high-quality packaging for drug products and medical devices through integrated processes.
Pfizer CentreOne is a pharmaceutical contract manufacturing organization (CMO) specializing in sterile injectables, including liquid, lyophilization, pre-filled syringes, vials, and cartridges. With extensive US manufacturing facilities and global regulatory support, they offer comprehensive capabilities, including antibody-drug conjugates, to support pharmaceutical drug development and commercialization worldwide.
Pacific Vial Manufacturing specializes in the production of state-of-the-art glass containers for the pharmaceutical industry. Based in Norton, MA, the company manufactures precision vials and similar glass packaging solutions, utilizing advanced technology to meet the specific needs of its B2B clients.
Based in York, PA, Pyramid Pharma Services provides aseptic fill/finish services for sterile injectable products. They specialize in commercial manufacturing for vials and prefilled syringes, supporting both clinical development and large-scale commercial production. The company offers comprehensive solutions for pharmaceutical and biotech clients.
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How to Choose a Company
- Evaluate their expertise in sourcing and processing specific glass types, particularly Type I borosilicate glass, and their capabilities for glass delamination testing, especially critical for pH-sensitive formulations or long-term stability studies. Request data on USP <660> and EP 3.2.1 compliance.
- Verify the manufacturer's cleanroom classification (e.g., ISO 5 / Grade A/B) and their track record with aseptic processing or sterile fill/finish for your specific product type. Insist on a clear understanding of their environmental monitoring program and gowning procedures, especially if dealing with parenteral drugs, aligning with EU GMP Annex 1 guidelines.
- Probe their methods for ensuring Container Closure Integrity (CCI) throughout the product lifecycle, including specific testing protocols (e.g., dye ingress, vacuum decay, headspace analysis). A common red flag is a lack of robust, validated leaker detection and fill volume accuracy (e.g., micro-leak or overfill) testing at speed, which can lead to costly batch recalls down the line.
- Assess their ability to scale from clinical trial batches to commercial volumes, including flexibility in minimum order quantities (MOQ) for your growth trajectory. Crucially, confirm their current Good Manufacturing Practices (cGMP) compliance, particularly FDA 21 CFR Part 211, and their experience navigating your target market's regulatory submissions (e.g., IND, NDA, BLA support).
Frequently Asked Questions
How do I choose between pull-seal and tip-seal ampoules for my product?
The choice between pull-seal and tip-seal ampoules depends largely on your drug product's viscosity, fill volume, and the desired opening method for the end-user. Pull-seal ampoules are typically formed by heating and pulling the glass, creating a fine capillary neck that requires more controlled breaking, often preferred for precise dosing or where minimal particulate generation during opening is paramount. Tip-seal ampoules are sealed by melting the glass at the tip, resulting in a slightly thicker, often easier-to-open neck, suitable for less viscous products and applications where user convenience is a higher priority. Discuss your specific product characteristics and target user experience with potential manufacturers to determine the optimal seal type and corresponding breaking strength.
What level of cleanroom classification is required for sterile ampoule filling, and why does it matter?
For sterile fill/finish ampoule manufacturing, the most critical areas where the drug product is exposed must meet ISO 5 (Class 100) or EU GMP Grade A/B cleanroom standards. This ensures an extremely low particulate and microbial count during the filling and sealing processes, directly preventing contamination of the injectable product. Surrounding areas typically require ISO 7 (Class 10,000) or EU GMP Grade C for gowning and material transfer, while less critical areas might be ISO 8 (Class 100,000) or EU GMP Grade D. It matters because regulatory bodies like the FDA and EMA mandate these classifications to guarantee product sterility and patient safety, especially for parenteral drugs that bypass the body's natural defenses.
What are the key considerations for preventing glass delamination in ampoules, and how do manufacturers address it?
Glass delamination—the shedding of glass flakes into the drug product—is a critical concern, particularly for injectable solutions. It's primarily driven by the interaction between the drug formulation (especially at high pH or with chelating agents) and the glass's inner surface, accelerated by heat during sterilization. To prevent this, manufacturers focus on using Type I borosilicate glass, which has excellent chemical resistance, and often employ specific treatment processes like ammonium sulfate washing or silicone coating. They also rigorously conduct extractables and leachables studies and accelerated stability testing, per USP <1660>, to assess potential interactions. A robust manufacturer will have validated processes and analytical capabilities to monitor for delamination risk throughout your product's lifecycle.