Baltimore-based Congruence Medical Solutions designs, develops and supplies drug-delivery devices that add precision and usability to standard prefillable syringes and other primary containers. The company is especially known for its award-winning Microliter Dosing Syringe, developed for difficult small-volume injections and recognized with the 2019 PDA Drug Delivery Innovation Award in partnership with Santen Pharmaceutical. Its platforms also address viscous and variable-dose therapies, home injection, and drug waste from vials, including through the ELDO™ technology selected for the Johnson & Johnson Innovation–JLABS and BARDA BLUE KNIGHT program.
ISO 11040 compliant prefillable syringes
Compliance program
Enable InjectionsFounded in 2010, Cincinnati-based Enable Injections develops and manufactures enFuse, a hands-free wearable drug-delivery platform that administers large-volume medications under the skin rather than intravenously. The company combines in-house design, development, and GMP-compliant manufacturing with a patient-centered approach, and its technology now supports the FDA-approved EMPAVELI Injector and other partner-branded delivery systems.CINCINNATI, OH
Kindeva Drug DeliveryFounded on the invention of the pressurized metered-dose inhaler in 1956, Kindeva Drug Delivery develops and manufactures drug-device combination products as a global contract development and manufacturing organization. Its specialist work spans injectable, inhalation and dermal delivery, supported by nearly one million square feet of cGMP facilities worldwide. The company’s Bridgeton, Missouri site adds more than 155,000 square feet of aseptic operations space for sterile injectable fill-finish production.COLUMBIA, MD
Innovative Health Sciences, LLCFounded in 2019 by medical engineer and inventor Andrew Sealfon, Innovative Health Sciences develops and commercializes non-electric syringe infusion systems for intravenous and subcutaneous medication delivery. Based in Chester, New York, the company’s Insignis system combines a mechanical 13.5-psi syringe driver with selectable flow-rate control, giving patients and clinicians a portable alternative to electronic infusion equipment. The system is FDA cleared, CE Mark approved, and supported by MDSAP and ISO 13485 certifications.CHESTER, NY
Laxxon MedicalFounded in 2017 by pharmaceutical professionals, Laxxon Medical develops 3D screen-printed drug delivery systems through its proprietary SPID®-Technology. Headquartered in New York City with research and development facilities in Jena, Germany, the company works with pharmaceutical partners on oral dosage forms that can control how active ingredients are released, including projects aimed at making injectable therapies available by mouth. Its platform supports development from small clinical batches through production at up to 1.5 million units per day.NEW YORK, NY