Founded 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.
FDA 21 CFR Part 210 and 211 cGMP
Compliance program
FDA 21 CFR Part 4 Regulation of Combination Products
Compliance program
FDA 21 CFR Part 11 Electronic Records and Electronic Signatures
Compliance program
ICH Q10 Pharmaceutical Quality System
Compliance program
FDA-approved aseptic cGMP manufacturing facility
Registration
FDA21CFRPART211
Quality certification
FDA
Quality certification
Slate Run PharmaceuticalsFounded in Columbus, Ohio, in 2014, Slate Run Pharmaceuticals is a pharmaceutical company led by industry veterans with more than 200 years of combined experience in generic medicines. The company supplies FDA-approved pharmaceuticals to healthcare customers, with a particular focus on dependable access to generic injectables.COLUMBUS, OH
Pharmaceutics International, Inc. (Pii)Founded in 1994, Pharmaceutics International, Inc. (Pii) is a Hunt Valley drug product contract development and manufacturing organization that takes pharmaceutical products from early development through clinical trials and commercial production. Now part of Jabil, Pii combines more than 30 years of complex-formulation experience with a 360,000-square-foot, four-site campus and more than 300 scientists and support staff. Its GMP facilities are built for demanding work, including potent compounds, complex injectables and oral drug products, with FDA-licensed and DEA-registered operations.HUNT VALLEY, MD
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
BioTechniqueBioTechnique is a pharmaceutical CRDMO in York, Pennsylvania, known for carrying sterile injectable products from clinical development through commercial manufacture. Its 268,000-square-foot facility gives pharmaceutical and biotech companies room to move projects through development and fill-finish production within one organization.YORK, PA