Founded 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.
ISO Certificate (FM 635537)
MDR Certificate
MDSAP Certificate
CE Mark under the European Union Medical Device Regulation (EU MDR)
United Kingdom MHRA Registration
Registration
Brazil ANVISA Registration
Registration
South Korea MFDS Marketing Authorization
Registration
ISO
Quality certification
MDR
Quality certification
UKMHRA
Quality certification
Congruence Medical Solutions LLCBaltimore-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.BALTIMORE, MD
Oakwood LabsFounded in 1997 in the Cleveland area, Oakwood Labs develops and manufactures sustained-release injectable pharmaceuticals through its proprietary Chroniject™ polymer microsphere platform. Its integrated operation connects formulation research and development with an FDA-approved aseptic cGMP facility, supporting products from early feasibility through clinical supply and commercial manufacturing. Oakwood has worked on more than 100 long-acting injectable projects and currently manufactures five FDA-approved commercial products.OAKWOOD VILLAGE, OH
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
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